Loomio
Tue 9 Oct 2018

Funding a SHAP clinical evaluation kit for an e-NABLE clinical study in South Florida (Nicklaus Children's Hospital, Miami, FL)

CC
Chad Coarsey Public Seen by 82

Research Funding Proposal: Scan2Make, The Bionic Glove Project et al.

-Proposal Background

The Bionic Glove Project, a registered 501 c3, has worked over the last 9 months to develop a novel five (5) year pilot study evaluating the efficacy of 3-D scanning for custom fitting of eNABLE devices and designing novel devices to increase access to 3-D printed orthotic and prosthetic devices to upper limb amputees. BGP is sponsoring the clinical trial and has assumed all costs for preparation. This research utilizes a multidisciplinary team in conjunction with pediatricians, orthopedists, orthotists/prosthetists, physical therapists, case workers,other e-NABLE chapters such as Handling the Future, 501 c3 (Tampa Bay area), and other clinical partners.

The clinical trial, entitled Scan2make has recently been given a greenlight for IRB approval (submitted independently by Nicklaus Children's Hospital) pending finalization of research agreements; however, in anticipation of the study, we are moving forward with our research funding request with the idea that the trial shall begin in December 2018 or January 2019. This will also allow us to finalize enrollment the clinical study on the FDA’s clinicaltrials.gov.

A critical part of this study will use a well-documented, standard clinical evaluation tool called the Southampton Hand Assessment Procedure (SHAP) (http://www.shap.ecs.soton.ac.uk/ ). Previously, our research collaborator has used this kit for evaluations of users with neurotrauma, and is an ideal clinical evaluator with 23 different options to test dexterity, grip, control, etc. for device testing in this study as well. We are seeking assistance to funding of £ 2050 ($2665) to purchase a kit, which will be provided to Nicklaus Children’s Hospital to evaluate e-NABLE devices and customized solutions for upper limb amputees in a clinical settings. The biggest aims are to evaluate the many different designs and fitting practices for a wide range of varying upper limb amputees, and understand where there may be an ideal device or practice for specific clinical case types. The e-NABLE community will also gain access to the protocols and will be informed regularly on updates. Many of the SHAP objects can be replicated, and another aim of this will be to identify the applicable SHAP tests that e-NABLE makers can perform for gaining feedback on previous and custom-made devices. A quality of life survey, PedsQL, will be administered to ascertain psychosocial feedback as well from the user.

-Motivation

The South Florida area has a population of over 6.6 million people (1), and The Bionic Glove Project has been approached with over 10 potential cases in the last year ranging from the the West and East coast of South Florida, 7 were deemed eligible for devices, of which 4 were e-NABLE devices including the Team UnLimited Arm, Raptor Reloaded 2 hand, and Phoenix V2 hand. One in five thousand children are born with a genetic birth defect which affects the growth of their hand(s), one in twenty thousand are born with hand defect caused by their arm, hand or fingers being occluded and constricted by the amniotic sac known as Amniotic Band Syndrome (2) Regarding congenital limb amputation, anomalies affecting only the hand plate accounted for 62% (296) of the malformations. Of these, radial polydactyly (15%) was the most common specific anomaly, followed by symbrachydactyly (13%) and cleft hand (11%) (2,3). Additionally, other cases which have presented include central deficiency which there have been 0.52/10,000 cases of this nature are reported annually. (3,4) It is then estimated that there are over two million amputees in the US ten million people worldwide (5,6) are in need some form of hand supplementation using a Personal Assistive Device , be it an e-NABLE or custom made design. This is apparent as healthcare costs for amputees are on the order of over 35% greater than able-bodied persons over their lifetime (5,6,7). This motivates a solution for adaptive devices that are low-cost and custom to the user. Furthermore, additional limitations are increased with physiological variation within the multiple degrees of congenital and acquired amputations, and further complicates the ability to streamline an active process for rapid prototyping and directly 3-D printing prosthetics with good manufacturing practice for upper limb amputees. This highlights the need to develop a strategy that can overcome this major barrier to provide custom-fit prosthetic solutions. To address this need, 3D scanning has been used in a clinical setting for both orthotics (8) and for prosthetic devices (9) to develop custom sockets and attachments for upper limb amputees (10).

The Bionic Glove project is committed to finding the best custom-fit orthotic and prosthetic devices for patients, while holding their safety and quality of care to the highest regard. They team with local medical, pediatric, orthopedic, and orthotist and prosthetist specialists to develop tools to address challenges for providing custom fit prosthetics for patients in the South Florida community. Previously, using 3-D scanning, the BGP has made customized flexible sockets for myoelectric integration (http://bit.ly/2Obc0AK), customized orthotic devices for e-NABLE cases without a custom or premade solution such as for cases with central deficiency (case 507) (http://bit.ly/2PmZgU5) or complex amniotic band syndrome (http://bit.ly/2IKT5a6). Therein, a standardized process can be developed using low-cost 3-D scanning and CAD to deliver a customized 3-D printed device for typical and unique upper limb amputee cases. To evaluate the efficacy of functional prosthetics, standardized clinical tests, like SHAP, test can be applied to measure the the degrees of freedom, functionality and quality of life for each case. Thus a full clinical trial is warranted to understand the benefits of integrating 3-D scanning and printing technologies for increasing access to customized prosthetic technology to upper limb amputees

-Budget Request
Southampton Hand Assessment Procedure kit to provide to Nicklaus Children's Hospital (Miami, FL) Cost: £2050.00 ($2665.00).

-Proposal

Research Plan:

Phase Timeline of Design Study by Year
Timeline figure: http://bit.ly/2ype3X9

A pilot study will attempt to recruit 50 participants from South Florida, which will take place over a five (5) year pilot period to allow for time for recruitment, due to the relatively low incidence of congenital hand deformities. The scanning technology used is widely commercially available, low cost and optimal for versatile point-of-care application. Initially this technology will be adopted into a design process, incorporating other CAD tools to enable a powerful and standard method of rendering custom fit prosthetics. Participant recruitment will begin following a formulized standard scanning and design strategy. Next, a toolset of parts that can be adapted to the 3-D scan will then be created. Once enrollment begins, participants will be asked to be evaluated for a prosthetic and 3-D scanned, then fitted. Non-adult participants (ages 2-17) will be asked to perform the PedsQL Measurement Model for the Quality of Life Inventory (PedsQL) two weeks after fitting, and participants thirteen (13) and older will be asked to perform a SHAP test to evaluate the ability of the custom fit prosthetic.

Research Methods:

Research Study Participant Involvement Timeline by Month
Timeline figure: http://bit.ly/2E9XhBm

First, after the potential participant has contacted the P.I. and expressed interest in the study, the participant or parent/guardian will be given an initial questionnaire via mail in a pre-stamped, self-addressed envelope, upon receiving interest in recruitment.

Within two (2) weeks, the Bionic Glove Project (BGP) will arrange for a clinical visit to ensure the participant meets all criteria to enter the study. This will involve likely a one (1) hour visit to the clinician office or at FAU. The participant will be asked to travel to the chosen clinic closest to the participant’s location.

If the participant meets all appropriate criteria, they will then be 3-D scanned. The scanning can take up to twenty (20) minutes and can be done at the clinic after evaluation. Alternatively, if the participant would like to request another appointment for 3-D scanning at Dr. Erik Engeberg’s BioRobotics Lab or another partner clinic they can do so. The prosthetic will be created from the participant’s 3-D scan using computer design software and will be printed out and assembled.

Once ready six (6) weeks from the participant’s initial scan, the participant will be asked to meet at a chosen clinic or at the BGP for a fitting. This can take up to one (1) hour, and consists of ensuring the prosthetic fits, using patient-feedback to enhance padding for their desired custom fit. The participant will also be instructed to use and care for their prosthetic.

Additionally, Teen and Adult participants, aged thirteen (13) or older, will be asked to perform a physical evaluation using the Southampton Hand Assessment Procedure (SHAP). This procedure will be conducted in five (5) minute intervals with ten (10) minutes of rest in between each trial attempt. The participant will be asked to perform a total number of four (4) trials for a total of one (1) hour.

The participant will be followed up two (2) weeks after the fitting to follow-up on the prosthetic and will be requested to complete a twenty (20) minute mail-in survey (PedsQL) depending on age of the participant, sent to the participant or participant’s parents/guardians for evaluation of the prosthetic, via mail in a pre-stamped, self-addressed envelope.

The participant will receive no financial compensation but will be able to keep the custom fit prosthetic for free, and have access to free future custom fit prosthetics, if desired, even if participation is ended prior to study completion.

Analysis Plan:

Analysis shall be three-fold. The first will be a quantitative measure of the ability to make the prosthetics with be measure in terms of time from scan to fitting the patient, materials and extra support hardware (e.g. machine screws, straps, 7x7 leader wire, wire crimps, and 3/8-inch rubber bands), and the burden of labor documented for each step in the design process.

Secondly, If the participant is age 2-18, parents the will be asked to fill out PedsQL Measurement Model for the Quality of Life Inventory (PedsQL) Parent Report for either Toddlers (ages 2-4), Young Children (ages 5-7), Children ages (8-12), or Teen (ages 13-18). Child (ages 8-12) and Teen participants (ages 13-18), will be asked to either take the PedsQL Child Report (ages 8-12) or Teen Report (ages 13-18), respectively. These are standardized, verified quality of life surveys. Parents/guardians of participants will be asked to complete surveys after informed consent is obtained. Surveys will be sent out and collected via mail in a pre-stamped, self-addressed envelope. Survey data will be stored in a locked drawer located in the BGP’s office.

Assessments Utilized by age:
2-4
PedsQL Parent Report
5-7
PedsQL Parent Report
8-12
PedsQL Parent and Child Report
13-17
PedsQL Parent and Teen Report, SHAP Test
18<
SHAP Test

Finally, Teen and Adult participants, ages thirteen (13) and older will be asked to conduct a Southampton Hand Assessment Procedure (SHAP) test, where they will be asked to perform various tasks including: grasping various objects on a flat surface and picking them up and place them into a target space or conveying a specific function such as rotating a screw or squeezing an irregular object.

-Resources

The BGP has all of the equipment necessary for this research, including 3-D printers, hardware, access to computers for CAD rendering and scanning infrastructure. Including P.I., Dr. Erik Engeberg of the FAU BioRobotics Lab, Dr. Patricia Anastasio M.D. of Pediatric Associates of Boca, Richard Brown, DO, of Handling the Future, Inc., Dr. Aaron Berger, MD. Ph.D., of Nicklaus Children’s Hospital, and David Falk, LPO CPO of Falk Prosthetics & Orthotics, John Calloway of Halo Technologies, LLC. and Christopher Scull or Delta Design, LLC. will be staff on this study. Clinical services such as physicals and fittings may be rendered at these locations. Any kind of social or medical services are extremely unlikely to be needed, but are within short distance of the Boca Raton FAU campus and any of the off-site locations.

Pediatric Associates of Boca, Nicklaus Children’s Hospital, and Falk Prosthetics & Orthotics; At these clinics sites, clinicians may use X-rays to help evaluate if the participant meets the study criteria.

Halo Technologies, LLC., Delta Design, LLC., are engineering manufacturers that will offer knowledge and expertise in CAD and 3-D Scanning and printing of rendered custom fit prosthetics.
Handling the Future, Inc. consists of a group of senior e-NABLE volunteers that fabricate and deliver 3-D printed prosthetics to amputees. They will contribute their subject-matter expertise, assist in scanning and socket fabrication and delivery.

-Outcomes

Innovation and Technology Development:

The study will lead to a standardized 3-D scanning technique for developing custom-fit 3-D printed orthotics and prosthetics and evaluated in clinical settings

Indirectly, case-specific prosthetics that are not currently being met with e-NABLE device designs will be made and delivered open-source.

Current e-NABLE devices will also have the opportunity to be evaluated in the clinical setting, dependent on case presentation, and tested through use of the SHAP .

SHAP tests that can be implemented on e-NABLE devices for clinical testing will be identified, and made available to the community.

-Community Engagement and Pedagogical Development

Promote local university and high school student volunteers enabling access to those with limb difference in the South Florida and contribute to global e-NABLE Community.

Allow student access to new and beneficial technology, and teaching them the importance of integrating such useful technologies in the most helpful of ways.

Creation of a platform for inquiry-based learning which incorporates the most effective and creative teaching practices to drive an environment capable of fostering passion and developing innovation.

-Citations

US Census, 2016 visited 9/26, https://factfinder.census.gov/faces/tableservices/jsf/pages/productview.xhtml?pid=PEP_2016_PEPANNRES&amp;prodType=table

Charles A. Goldfarb, Lindley B. Wall, Deborah C. Bohn, Patrick Moen, Ann E. Van Heest, Epidemiology of Congenital Upper Limb Anomalies in a Midwest United States Population: An Assessment Using the Oberg, Manske, and Tonkin Classification, The Journal of Hand Surgery, Volume 40, Issue 1, 2015, Pages 127-132.e2, ISSN 0363-5023, https://doi.org/10.1016/j.jhsa.2014.10.038.

Koskimies E, Lindfors N, Gissler M, Peltonen J, Nietosvaara Y. Congenital upper limb deficiencies and associated malformations in Finland: a population-based study. J Hand Surg [Am] 2011;36:1058–1065.; Link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4094123/

Dy, Christopher J., Ishaan Swarup, and Aaron Daluiski. "Embryology, diagnosis, and evaluation of congenital hand anomalies."Current reviews in musculoskeletal medicine 7.1 (2014): 60-67.) Link: https://www.ncbi.nlm.nih.gov/pubmed/24515896

Ziegler‐Graham K, MacKenzie EJ, Ephraim PL, Travison TG, Brookmeyer R. Estimating the Prevalence of Limb Loss in the United States: 2005 to 2050. Archives of Physical Medicine and Rehabilitation2008;89(3):422‐9.

Center for Health S. Ambulatory and Inpatient Procedures in the United States, 1996. Hyattsville, Md.: U.S. Dept. of Health and Human Services, Centers for Disease Control and Prevention, National Center for Health Statistics; 1998.

HCUP Nationwide Inpatient Sample (NIS). Healthcare Cost and Utilization Project (HCUP). Rockville, MD: Agency for Healthcare Research and Quality; 2009.

Volonghi, Paola, Gabriele Baronio, and Alberto Signoroni. "3D scanning and geometry processing techniques for customised hand orthotics: an experimental assessment." Virtual and Physical Prototyping 13.2 (2018): 105-116.

Liacouras, Peter C., et al. "Using computed tomography and 3D printing to construct custom prosthetics attachments and devices." 3D printing in medicine 3.1 (2017): 8.

Tian, Li, et al. "A Methodology to Model and Simulate Customized Realistic Anthropomorphic Robotic Hands." Proceedings of Computer Graphics International 2018. ACM, 2018.

CC

Chad Coarsey started a proposal Tue 9 Oct 2018

Funding a SHAP clinical evaluation kit for an e-NABLE clinical study in South Florida (Nicklaus Children's Hospital, Miami, FL) Closed Fri 19 Oct 2018

Outcome
by Chad Coarsey Sat 20 Oct 2018

With over 90% and quorum requirements met, we have approved the proposal. I am happy to the support and willingness of all to be involved in this clinical study. Stay tuned for updates in the coming months regarding the purchase of the kit (could take 6-8 weeks shipping from the UK), and the progress of preparing for and initiating the clinical trial. For any questions please feel free to reach me at: ccoarsey@bionicglove.org.
Thank you all again for your support! I look forward to collaborating with the community on this clinical study!

Chad Coarsey, M.S.

Research Funding Proposal: Scan2Make, The Bionic Glove Project et al.

-Proposal Background

The Bionic Glove Project, a registered 501 c3, has worked over the last 9 months to develop a novel five (5) year pilot study evaluating the efficacy of 3-D scanning for custom fitting of eNABLE devices and designing novel devices to increase access to 3-D printed orthotic and prosthetic devices to upper limb amputees. BGP is sponsoring the clinical trial and has assumed all costs for preparation. This research utilizes a multidisciplinary team in conjunction with pediatricians, orthopedists, orthotists/prosthetists, physical therapists, case workers,other e-NABLE chapters such as Handling the Future, 501 c3 (Tampa Bay area), and other clinical partners.

The clinical trial, entitled Scan2make has recently been given a greenlight for IRB approval (submitted independently by Nicklaus Children's Hospital) pending finalization of research agreements; however, in anticipation of the study, we are moving forward with our research funding request with the idea that the trial shall begin in December 2018 or January 2019. This will also allow us to finalize enrollment the clinical study on the FDA’s clinicaltrials.gov.

A critical part of this study will use a well-documented, standard clinical evaluation tool called the Southampton Hand Assessment Procedure (SHAP) (http://www.shap.ecs.soton.ac.uk/). Previously, our research collaborator has used this kit for evaluations of users with neurotrauma, and is an ideal clinical evaluator with 23 different options to test dexterity, grip, control, etc. for device testing in this study as well. We are seeking assistance to funding of £ 2050 ($2665) to purchase a kit, which will be provided to Nicklaus Children’s Hospital to evaluate e-NABLE devices and customized solutions for upper limb amputees in a clinical settings. The biggest aims are to evaluate the many different designs and fitting practices for a wide range of varying upper limb amputees, and understand where there may be an ideal device or practice for specific clinical case types. The e-NABLE community will also gain access to the protocols and will be informed regularly on updates. Many of the SHAP objects can be replicated, and another aim of this will be to identify the applicable SHAP tests that e-NABLE makers can perform for gaining feedback on previous and custom-made devices. A quality of life survey, PedsQL, will be administered to ascertain psychosocial feedback as well from the user.

-Motivation

The South Florida area has a population of over 6.6 million people (1), and The Bionic Glove Project has been approached with over 10 potential cases in the last year ranging from the the West and East coast of South Florida, 7 were deemed eligible for devices, of which 4 were e-NABLE devices including the Team UnLimited Arm, Raptor Reloaded 2 hand, and Phoenix V2 hand. One in five thousand children are born with a genetic birth defect which affects the growth of their hand(s), one in twenty thousand are born with hand defect caused by their arm, hand or fingers being occluded and constricted by the amniotic sac known as Amniotic Band Syndrome (2) Regarding congenital limb amputation, anomalies affecting only the hand plate accounted for 62% (296) of the malformations. Of these, radial polydactyly (15%) was the most common specific anomaly, followed by symbrachydactyly (13%) and cleft hand (11%) (2,3). Additionally, other cases which have presented include central deficiency which there have been 0.52/10,000 cases of this nature are reported annually. (3,4) It is then estimated that there are over two million amputees in the US ten million people worldwide (5,6) are in need some form of hand supplementation using a Personal Assistive Device , be it an e-NABLE or custom made design. This is apparent as healthcare costs for amputees are on the order of over 35% greater than able-bodied persons over their lifetime (5,6,7). This motivates a solution for adaptive devices that are low-cost and custom to the user. Furthermore, additional limitations are increased with physiological variation within the multiple degrees of congenital and acquired amputations, and further complicates the ability to streamline an active process for rapid prototyping and directly 3-D printing prosthetics with good manufacturing practice for upper limb amputees. This highlights the need to develop a strategy that can overcome this major barrier to provide custom-fit prosthetic solutions. To address this need, 3D scanning has been used in a clinical setting for both orthotics (8) and for prosthetic devices (9) to develop custom sockets and attachments for upper limb amputees (10).

The Bionic Glove project is committed to finding the best custom-fit orthotic and prosthetic devices for patients, while holding their safety and quality of care to the highest regard. They team with local medical, pediatric, orthopedic, and orthotist and prosthetist specialists to develop tools to address challenges for providing custom fit prosthetics for patients in the South Florida community. Previously, using 3-D scanning, the BGP has made customized flexible sockets for myoelectric integration (http://bit.ly/2Obc0AK), customized orthotic devices for e-NABLE cases without a custom or premade solution such as for cases with central deficiency (case 507) (http://bit.ly/2PmZgU5) or complex amniotic band syndrome (http://bit.ly/2IKT5a6). Therein, a standardized process can be developed using low-cost 3-D scanning and CAD to deliver a customized 3-D printed device for typical and unique upper limb amputee cases. To evaluate the efficacy of functional prosthetics, standardized clinical tests, like SHAP, test can be applied to measure the the degrees of freedom, functionality and quality of life for each case. Thus a full clinical trial is warranted to understand the benefits of integrating 3-D scanning and printing technologies for increasing access to customized prosthetic technology to upper limb amputees

-Budget Request
Southampton Hand Assessment Procedure kit to provide to Nicklaus Children's Hospital (Miami, FL) Cost: £2050.00 ($2665.00).

-Proposal

Research Plan:

Phase Timeline of Design Study by Year
Timeline figure: http://bit.ly/2ype3X9

A pilot study will attempt to recruit 50 participants from South Florida, which will take place over a five (5) year pilot period to allow for time for recruitment, due to the relatively low incidence of congenital hand deformities. The scanning technology used is widely commercially available, low cost and optimal for versatile point-of-care application. Initially this technology will be adopted into a design process, incorporating other CAD tools to enable a powerful and standard method of rendering custom fit prosthetics. Participant recruitment will begin following a formulized standard scanning and design strategy. Next, a toolset of parts that can be adapted to the 3-D scan will then be created. Once enrollment begins, participants will be asked to be evaluated for a prosthetic and 3-D scanned, then fitted. Non-adult participants (ages 2-17) will be asked to perform the PedsQL Measurement Model for the Quality of Life Inventory (PedsQL) two weeks after fitting, and participants thirteen (13) and older will be asked to perform a SHAP test to evaluate the ability of the custom fit prosthetic.

Research Methods:

Research Study Participant Involvement Timeline by Month
Timeline figure: http://bit.ly/2E9XhBm

First, after the potential participant has contacted the P.I. and expressed interest in the study, the participant or parent/guardian will be given an initial questionnaire via mail in a pre-stamped, self-addressed envelope, upon receiving interest in recruitment.

Within two (2) weeks, the Bionic Glove Project (BGP) will arrange for a clinical visit to ensure the participant meets all criteria to enter the study. This will involve likely a one (1) hour visit to the clinician office or at FAU. The participant will be asked to travel to the chosen clinic closest to the participant’s location.

If the participant meets all appropriate criteria, they will then be 3-D scanned. The scanning can take up to twenty (20) minutes and can be done at the clinic after evaluation. Alternatively, if the participant would like to request another appointment for 3-D scanning at Dr. Erik Engeberg’s BioRobotics Lab or another partner clinic they can do so. The prosthetic will be created from the participant’s 3-D scan using computer design software and will be printed out and assembled.

Once ready six (6) weeks from the participant’s initial scan, the participant will be asked to meet at a chosen clinic or at the BGP for a fitting. This can take up to one (1) hour, and consists of ensuring the prosthetic fits, using patient-feedback to enhance padding for their desired custom fit. The participant will also be instructed to use and care for their prosthetic.

Additionally, Teen and Adult participants, aged thirteen (13) or older, will be asked to perform a physical evaluation using the Southampton Hand Assessment Procedure (SHAP). This procedure will be conducted in five (5) minute intervals with ten (10) minutes of rest in between each trial attempt. The participant will be asked to perform a total number of four (4) trials for a total of one (1) hour.

The participant will be followed up two (2) weeks after the fitting to follow-up on the prosthetic and will be requested to complete a twenty (20) minute mail-in survey (PedsQL) depending on age of the participant, sent to the participant or participant’s parents/guardians for evaluation of the prosthetic, via mail in a pre-stamped, self-addressed envelope.

The participant will receive no financial compensation but will be able to keep the custom fit prosthetic for free, and have access to free future custom fit prosthetics, if desired, even if participation is ended prior to study completion.

Analysis Plan:

Analysis shall be three-fold. The first will be a quantitative measure of the ability to make the prosthetics with be measure in terms of time from scan to fitting the patient, materials and extra support hardware (e.g. machine screws, straps, 7x7 leader wire, wire crimps, and 3/8-inch rubber bands), and the burden of labor documented for each step in the design process.

Secondly, If the participant is age 2-18, parents the will be asked to fill out PedsQL Measurement Model for the Quality of Life Inventory (PedsQL) Parent Report for either Toddlers (ages 2-4), Young Children (ages 5-7), Children ages (8-12), or Teen (ages 13-18). Child (ages 8-12) and Teen participants (ages 13-18), will be asked to either take the PedsQL Child Report (ages 8-12) or Teen Report (ages 13-18), respectively. These are standardized, verified quality of life surveys. Parents/guardians of participants will be asked to complete surveys after informed consent is obtained. Surveys will be sent out and collected via mail in a pre-stamped, self-addressed envelope. Survey data will be stored in a locked drawer located in the BGP’s office.

Assessments Utilized by age:
2-4
PedsQL Parent Report
5-7
PedsQL Parent Report
8-12
PedsQL Parent and Child Report
13-17
PedsQL Parent and Teen Report, SHAP Test
18<
SHAP Test

Finally, Teen and Adult participants, ages thirteen (13) and older will be asked to conduct a Southampton Hand Assessment Procedure (SHAP) test, where they will be asked to perform various tasks including: grasping various objects on a flat surface and picking them up and place them into a target space or conveying a specific function such as rotating a screw or squeezing an irregular object.

-Resources

The BGP has all of the equipment necessary for this research, including 3-D printers, hardware, access to computers for CAD rendering and scanning infrastructure. Including P.I., Dr. Erik Engeberg of the FAU BioRobotics Lab, Dr. Patricia Anastasio M.D. of Pediatric Associates of Boca, Richard Brown, DO, of Handling the Future, Inc., Dr. Aaron Berger, MD. Ph.D., of Nicklaus Children’s Hospital, and David Falk, LPO CPO of Falk Prosthetics & Orthotics, John Calloway of Halo Technologies, LLC. and Christopher Scull or Delta Design, LLC. will be staff on this study. Clinical services such as physicals and fittings may be rendered at these locations. Any kind of social or medical services are extremely unlikely to be needed, but are within short distance of the Boca Raton FAU campus and any of the off-site locations.

Pediatric Associates of Boca, Nicklaus Children’s Hospital, and Falk Prosthetics & Orthotics; At these clinics sites, clinicians may use X-rays to help evaluate if the participant meets the study criteria.

Halo Technologies, LLC., Delta Design, LLC., are engineering manufacturers that will offer knowledge and expertise in CAD and 3-D Scanning and printing of rendered custom fit prosthetics.
Handling the Future, Inc. consists of a group of senior e-NABLE volunteers that fabricate and deliver 3-D printed prosthetics to amputees. They will contribute their subject-matter expertise, assist in scanning and socket fabrication and delivery.

-Outcomes

Innovation and Technology Development:

The study will lead to a standardized 3-D scanning technique for developing custom-fit 3-D printed orthotics and prosthetics and evaluated in clinical settings

Indirectly, case-specific prosthetics that are not currently being met with e-NABLE device designs will be made and delivered open-source.

Current e-NABLE devices will also have the opportunity to be evaluated in the clinical setting, dependent on case presentation, and tested through use of the SHAP .

SHAP tests that can be implemented on e-NABLE devices for clinical testing will be identified, and made available to the community.

-Community Engagement and Pedagogical Development

Promote local university and high school student volunteers enabling access to those with limb difference in the South Florida and contribute to global e-NABLE Community.

Allow student access to new and beneficial technology, and teaching them the importance of integrating such useful technologies in the most helpful of ways.

Creation of a platform for inquiry-based learning which incorporates the most effective and creative teaching practices to drive an environment capable of fostering passion and developing innovation.

-Citations

US Census, 2016 visited 9/26, https://factfinder.census.gov/faces/tableservices/jsf/pages/productview.xhtml?pid=PEP_2016_PEPANNRES&amp;prodType=table

Charles A. Goldfarb, Lindley B. Wall, Deborah C. Bohn, Patrick Moen, Ann E. Van Heest, Epidemiology of Congenital Upper Limb Anomalies in a Midwest United States Population: An Assessment Using the Oberg, Manske, and Tonkin Classification, The Journal of Hand Surgery, Volume 40, Issue 1, 2015, Pages 127-132.e2, ISSN 0363-5023, https://doi.org/10.1016/j.jhsa.2014.10.038.

Koskimies E, Lindfors N, Gissler M, Peltonen J, Nietosvaara Y. Congenital upper limb deficiencies and associated malformations in Finland: a population-based study. J Hand Surg [Am] 2011;36:1058–1065.; Link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4094123/

Dy, Christopher J., Ishaan Swarup, and Aaron Daluiski. "Embryology, diagnosis, and evaluation of congenital hand anomalies."Current reviews in musculoskeletal medicine 7.1 (2014): 60-67.) Link: https://www.ncbi.nlm.nih.gov/pubmed/24515896

Ziegler‐Graham K, MacKenzie EJ, Ephraim PL, Travison TG, Brookmeyer R. Estimating the Prevalence of Limb Loss in the United States: 2005 to 2050. Archives of Physical Medicine and Rehabilitation2008;89(3):422‐9.

Center for Health S. Ambulatory and Inpatient Procedures in the United States, 1996. Hyattsville, Md.: U.S. Dept. of Health and Human Services, Centers for Disease Control and Prevention, National Center for Health Statistics; 1998.

HCUP Nationwide Inpatient Sample (NIS). Healthcare Cost and Utilization Project (HCUP). Rockville, MD: Agency for Healthcare Research and Quality; 2009.

Volonghi, Paola, Gabriele Baronio, and Alberto Signoroni. "3D scanning and geometry processing techniques for customised hand orthotics: an experimental assessment." Virtual and Physical Prototyping 13.2 (2018): 105-116.

Liacouras, Peter C., et al. "Using computed tomography and 3D printing to construct custom prosthetics attachments and devices." 3D printing in medicine 3.1 (2017): 8.

Tian, Li, et al. "A Methodology to Model and Simulate Customized Realistic Anthropomorphic Robotic Hands." Proceedings of Computer Graphics International 2018. ACM, 2018.

Agree - 23
Abstain - 2
Disagree - 0
Block - 0
25 people have voted (22%)
RK

Richard Kim
Agree
Tue 9 Oct 2018

TO

Thierry Oquidam
Abstain
Tue 9 Oct 2018

SM

Skip Meetze
Agree
Tue 9 Oct 2018

JS

Jeremy Simon
Agree
Tue 9 Oct 2018

PB

Peter Binkley
Agree
Tue 9 Oct 2018

Good idea!

KB

Ken Bice
Agree
Wed 10 Oct 2018

RB

Rich B
Agree
Wed 10 Oct 2018

JS

Jack Sutcliffe
Agree
Wed 10 Oct 2018

JO

Jen Owen
Agree
Wed 10 Oct 2018

E

ebubar
Agree
Thu 11 Oct 2018

FP

Fricis Pirtnieks
Agree
Thu 11 Oct 2018

3D prosthetics have very poor acceptance from clinicians, because of lack of structured evidence.

LG

Leland Green
Agree
Thu 11 Oct 2018

Chad has proven his expertise as a graduate student. IMHO, he's one of the best people we could possibly recruit for doing this sort of thing.

If anything, his background should lend credence to the tests (in the eyes of the medical and education communities).

SAP

Sarah Anne Paynter
Agree
Thu 11 Oct 2018

YA

Yourdy Alcaide
Agree
Thu 11 Oct 2018

RV

Richard VanderMey
Agree
Thu 11 Oct 2018

Keep up the good work Chad.

EM

emanuelcruz07@gmail.com
Agree
Thu 11 Oct 2018

J

Jen
Agree
Sat 13 Oct 2018

P

Patrick
Abstain
Sun 14 Oct 2018

How much are you asking for? One time or continual funding? I will re-read.

QM

Quinn Morley
Agree
Sun 14 Oct 2018

JS

Jon Schull
Agree
Mon 15 Oct 2018

Great proposal!

P

Patrick
Abstain
Mon 15 Oct 2018

I am not sold on the idea yet. A few details still pop out.

AT

Ashley Turner
Agree
Tue 16 Oct 2018

RH

Richard Hodgdon
Agree
Fri 19 Oct 2018

P

Patrick
Disagree
Fri 19 Oct 2018

A few details need to be worked out. Still a good idea, but certain details pop out. Is there any chapter or company you are affiliated with? Where will these funds be going? And what is the breakdown. Great idea, but the lack of a budget still startles me. May change vote once details are brought together.

P

Patrick
Abstain
Fri 19 Oct 2018

What is the hospital timetable. Are you able to bring your timeline back 30-days to reevaluate these areas? Entity and budget. A few details need to be worked out. Still a good idea, but certain details pop out. Is there any chapter or company you are affiliated with? Where will these funds be going? And what is the breakdown. Great idea, but the lack of a budget still startles me. May change vote once details are brought together.

WM

Wayne Munslow
Agree
Fri 19 Oct 2018

JB

Jacquin Buchanan
Agree
Fri 19 Oct 2018

AA

Adam Armfield
Agree
Fri 19 Oct 2018

KB

Ken Bice Tue 9 Oct 2018

Does anyone know how much remains in the funding pool? This proposal seems to request more than others have previously. This is a very well explained proposal with considerable professional support behind it, and I believe it would benefit e-NABLE, but I don’t know what’s remaining in the pool for other worthy proposals. Does anyone know?

CC

Chad Coarsey Tue 9 Oct 2018

I have asked a similar question to Jon Schull in regards to funding caps a few months ago in anticipation of this proposal. I think he may know better. The best thing is that with this one cost, we can select what tests are applicable to e-NABLE devices from a clinical medicine standpoint, which can be replicated very easily for the whole community to use in their potential evaluations. I know its not the best answer, but highlights the value and benefit

JS

Jon Schull Tue 9 Oct 2018

Roughly speaking there's probably 10-15k uncommitted

RV

Richard VanderMey Thu 11 Oct 2018

Thank you for your proposal. Can you breakdown some of the costs, and will this Certification be available for cases outside of Florida?

CC

Chad Coarsey Thu 11 Oct 2018

Hi Richard, thank you for your question. The only cost we are asking for from e-NABLE is for the SHAP for clinical testing. The Bionic Glove Project is assuming ALL other costs, including for initial clinical evaluation by physician, 3D scanning services, manufacturing, assembly and fitting of devices for the study. Although localized in South Florida (West and East Coast south of Orlando), represents almost 2% of the entire US population. We will be evaluating upper limb devices with a standardized clinical method (SHAP kit) and by psychosocial method (PedsQL). These devices are available from the e-NABLE repositories (i.e. raptor, pheonix, team unlimbited, etc) or customized devices, either scaled or built around 3D scans. The outcome will directly benefit the entire e-NABLE community by generating the clinical and psychosocial data from the study for these devices in use. Indirectly, access to the SHAP kit will allow us to determine and allow replication of the testing materials in the kit and protocols; which can ne used by any e-NABLE chapter to test devices and case compliance, and for developing customized devices from 3D scans for more complex cases.

CC

Chad Coarsey Thu 11 Oct 2018

The SHAP kit costs £2050 (~$2665), and is the only item for purchase in the proposal. To find out more about the kit and its 23 procedures you can find it on their website:

http://www.shap.ecs.soton.ac.uk/

RV

Richard VanderMey Thu 11 Oct 2018

Thank you Chad for your Speedy reply. Will this effect all forms of 3D printed devices, or just the bionics? I am a maker as well as a designer, this program sounds exciting, and really qualifies the use of 3D printing of devices. I support your endeavours 100%.

CC

Chad Coarsey Thu 11 Oct 2018

Richard we are aiming across the board! We are focused on both body-powered and bionics as well. With this all said, I think we will try to idealy start a pipeline within the eNABLE Web Central to get more designers involved on a collaborative level united!

RV

Richard VanderMey Thu 11 Oct 2018

That sounds like a Great Program Chad. I look forward to being a helping hand in your work.

P

Patrick Sun 14 Oct 2018

"as assumed all costs for preparation". Does any cost occur after?

CC

Chad Coarsey Sun 14 Oct 2018

Patrick, No this is a one-time cost of roughly ~$2665 we are asking from the e-NABLE R&D fund (converted from 2050 pounds sterling). It is a standard clinical evaluation tool that has been used in Prosthetics for over 20 years. ALL OTHER costs prior, during and after the study are being assumed by the Bionic Glove Project. BGP is also carrying its own general and products liability insurance and will not need to depend on e-NABLE APBLS for this.

P

Patrick Sun 14 Oct 2018

I apologize but I have seen hospitals (the boards of trustees rather) assume projects to watch them fail as American hospitals have a "for profit" model.

CC

Chad Coarsey Sun 14 Oct 2018

I am sorry for your previous experience with for-profit hospitals in the united states. Nicklaus Children's Hospital is a Private hospital but is funded by its 501c3 foundation, the Nicklaus Children’s Hospital Foundation. We have a 3+ year working relationship with the hospital and are in specific clinical research agreements to protect the study. Everyone we have spoken with agrees this study will benefit not only their patients, but the future of 3-D printed prosthesis, positively. I hope you can change your abstention to a "yes" with all this information. Please let me know if there is any other information you need.

P

Patrick Mon 15 Oct 2018

Which device do you plan to use? I can see this potentially working with 1-device. What do you hope to do with these results? We never stop people from using devices for their cause, but this sounds as if you want our support and financial support in a few cases, which would follow more of a "chapter model". In privatizing anything, it is difficult to see how an open-source model would fit in, but it always great to help. Can you illustrate when I may be incorrect in making this comment?

My comment is based on the idea that regulating it may increase cost while 3d-printing these research designs will absolutely lower the cost and increase the satisfaction of life of those involved. Do you believe this will be more of a chapter model where you can help the local hospitals, or do you believe this will lead to privation and cost increase? Getting the local schools and hospitals involved is always great.

CC

Chad Coarsey Mon 15 Oct 2018

Patrick, I am not sure where you got the notion of privatization, this is NOT the case. We are simply conducting an unprecedented, clinical study on the psychosocial and clinical feedback from both pre-made e-NABLE designs and custom designs. We have an opportunity to partner with clinicians that at e-NABLEcon 2018, was discussed as a great benefit to the movement. There is a gap of feedback from the clinic and from the user. In the proposal, we lay out through the SHAP test (the one time cost we are asking funds for) and the PedsQL a standardized quality of life evaluation. If you read in the comments, I have addressed the notion that we are open "across the board" regarding which e-NABLE designs we are testing. This is a 5 year pilot study, with the aims of registering up to 50 participants with varying degrees of upper limb amputation; thus there will be pertinent device designs specific to each case (e.g. wrist disarticulation, trans-radial and trans-humeral) For more complex or unaddressed cases (i.e. complex amniotic band syndrome and Central deficiency) , we will be creating body-powered devices to fit them as well with the intention these will also be released open-source. There are certain inclusion/exclusion criteria as well to screen by our P.I. Dr. Aaron Berger, MD PhD., and we have a team of O&Ps and PTs ready to also be involved. The FDA has stated that these are class 1 with execption medical devices, and are not subject to regulation. However, with no true clinical or standardized psychosocial data, we hope to identify any designs which may give better promise to specific cases, and publish results for future e-NABLE work. The Bionic Glove Project, my company is a non-profit, and strictly donor and grant supported, this is the reason why we are pursuing this avenue of funding. On the contrary, this R& D fund was set up for this exact cause, to further the science behind e-NABLE devices, and our study aligns directly with this notion.

JS

Jon Schull Mon 15 Oct 2018

I don't see anything about privatizing in this proposal...?

CC

Chad Coarsey Mon 15 Oct 2018

Exactly right, there is no mention of privatization of designs, because this is not the study's intention at all!

P

Patrick Mon 15 Oct 2018

With hospitals come insurance, I am just curious as to the waiver process and putting them name behind it. I love the idea of helping others though. Maybe I am incorrect and hopefully a thorough explanation will help.

CC

Chad Coarsey Mon 15 Oct 2018

See my previous e-mail I just sent you

P

Patrick Mon 15 Oct 2018

Did not see any email but feel free to write everything here.

CC

Chad Coarsey Mon 15 Oct 2018

If you read my previous response, I have stated that my non-profit company, The Bionic Glove Project, is carrying a general and Products liability insurance and is NOT depending on e-NABLE to cover this. This is $1,000,000 and $2,000,000, respectively. We are asking e-NABLE to only assist with one aspect (critical nonetheless) of funding and the BGP, being sponsor/investigator, and Nicklaus Children's Hospital investigator Dr. Berger assumes ALL liability. We are also offering NCH the option to be additionally insured through our policy in good faith (pending finalization of the clinical research agreement )
We have an approved Institutional Review Board protocol that includes the informed consent process. We have allowed the ages 2-65 to be involved as participants and there are varying degrees of forms depending on the age-appropriate cognition. Participants under 18 will have a parents sign an assent form as well. We are not enrolling anyone who is a prisoner/incarcerated or anyone who is mentally-incapacitated or non-cognizant. The forms are either sent out and signed and notarized, and sent back to us, and when they come to the clinic, the forms are read to them. This is after the participant (or guardian) reaches out in response to a research flier, that details all the aspects, benefits and risks of the research. The consent forms again vary depending on age, for ages 5-7 for instance the description of the study is in plain English. Alternatively, participants that are referred by clinicians have the flier, and can sign consent forms in the clinic, and those are also read to them at that point-of-care. BGP will not be using the participants in any gain other than that they produce the valuable clinical and psychosocial data we expect as an outcome. This is also explained in the consent process. The participants may quit the study any time without penalty and still keep their device, and can request future devices if wanted. Again, this is explained in the informed consent process.
If you are not familiar, your concerns should alleviated as we must have IRB approval before the study is sent. IRB committees oversee any human research in any level of human involvement. They have stringent guidelines set forth by the HHS that are adhered too and scrutinize the submitted research protocol just as you are doing, prior to any enrollment of a clinical study. This IRB approval is something I mentioned in the beginning of the proposal, so again, rest assured. Nicklaus Children Hospital, as the investigator and site of the study is responsible for the IRB approval, and since we have all met these benchmarks, we are pursuing funding in anticipation that the clinical research agreement will be finalized within the next 4 weeks.

P

Patrick Mon 15 Oct 2018

One thing, why omit "prisoner/incarcerated or anyone who is mentally-incapacitated or non-cognizant." I am still reading this, I really love how you are responding to this, but the ultimate fear is making this less available to people. Everyone needs hand sometimes.

RB

Rich B Mon 15 Oct 2018

I hate to jump into a good intellectual debate, but I see an assumption that the results will limit device use. Perhaps it will increase use. Case in point, our HTF chapter of e-NABLE went to the Tampa Shriners Hospital and was closed out of giving help because of IRB's restricting the use of materials and use not functionally tested...this could open a new door!

P

Patrick Tue 16 Oct 2018

I am not sold on the idea yet.

JS

Jon Schull Tue 16 Oct 2018

Patrick, unanimity is not required, rubber-stamping not encouraged. You should feel free to Disagree or Abstain. I appreciate your diligence.

P

Patrick Tue 16 Oct 2018

Fair enough. I would have to disagree in terms of the aim of making the project inclusive, but agree in that it may be a good opportunity. I prefer to deliberate the idea and the details, but in this instance if the idea is desired by the hospital, where does e-NABLE funding or name need to come into play if this is an open source design?

I agree with: "Indirectly, case-specific prosthetics that are not currently being met with e-NABLE device designs will be made and delivered open-source."

I agree with:" Promote local university and high school student volunteers enabling access to those with limb difference in the South Florida and contribute to global e-NABLE Community."

But again, if I read correctly it says the hospital has all the resources. Thus, where does the need for funding come in?

CC

Chad Coarsey Tue 16 Oct 2018

This is incorrect. I said my company, the Bionic Glove Project, a non-profit and ecpected to disclose financial records, is assuming ALL COSTS

CC

Chad Coarsey Tue 16 Oct 2018

We are literally e-NABLE volunteers testing devices, i have said this to you in your first question.

LG

Leland Green Tue 16 Oct 2018

Hey Patrick, I believe Chad is only asking for help with purchasing the SHAP test device. I admit, I had to google it. This merely is a tool that Chad will have available for e-NABLE testing from now on to asses e-NABLE devices. http://www.shap.ecs.soton.ac.uk/

IMO, he's done due-diligence by lining up the first (excellent) evaluation, or "use case". The mentions of the clinic, doctors and all. That's merely one step in the long road that he plans to travel! :slight_smile:

Maybe this will help convince you. Or maybe you already understood all that. Either way, this is a summary of why I voted yes.

CC

Chad Coarsey Tue 16 Oct 2018

The idea comes from e-NABLE volunteers, not a Hospital. We approached them...

We are not preventing access to devices for anyone.

However, in general, research on humans in vulnerable situations is discouraged for many reasons. I encourage you to read the 1974 Belmont Report. It is available on the US HHS website. We are involving children in this study which are a vulnerable population (incognizant). The benefits outweigh the risks as these devices are also intended for pediatric cases. This is also why as I laid out that there is a detailed informed consent and assent process. We are not researching on incarcerated individuals because neither I nor the hospital has access to these cases. But still does not bar them for upper limb devices. Please understand the distinction between research and commercialization here. We also are not targeting developmentally delayed or unconscious individuals as research requires us to justify benefit over potential risk and part of our inclusion criteria states that the users must be able to be approved by a clinician for a device. If those individuals are unable, they are at more risk of harm than potential benefit. This again is all in the context of RESEACH, not commericalizing products.

P

Patrick Tue 16 Oct 2018

As Jon said "unanimity is not required, rubber-stamping not encouraged". I am very interested in picking out as many items as I can due to the nature of using minimal resources. I do appreciate you replying.

  1. Can this be something where a chapter can hop on and help? Maybe even a school to form the bonds you speak of.

  2. For the funding, what is the breakdown exactly? I see the number, but if the hospital can afford to pickup the cost, I am just curious as to what might be missing/what can help you get to that endgame.

It is truly about helping as many people as we can, I do not mean to discourage, thus the deliberation continues!

CC

Chad Coarsey Tue 16 Oct 2018

  1. Yes, see my above comments already addressing this. We are embracing collaboration.

  2. The hospital is donating the site, the physician and their services, including clinical evaluation of each case for free, including a physical and any diagnostic tools (i.e. x-rays ultrasound, etc.). The hospital as the site and the prinicipal investigator employed by the hospital assumes liability. They also assume any costs associated with follow up care and specialist referrals where applicable.


Cost breakdown

  1. One SHAP kit - £2050

This is a clinical research tool as I have stated. The proposal is evaluating e-NABLE devices, that are being created by my company for every participant in the study, comprising of e-NABLE volunteers. We are applying for funding as Sponsors of the trial which we initiated. This is exactly in accordance of why this fund was established.

Now personally, I have one hand, and its hurting now from these justifications you demand. I am now repeating a lot of the above proposal, comments addressed to others, and comments to you. I cannot make this simpler to you in writing. Call me tomorrow (10/16) after 2pm EST, if you still have reservations to give you a clearer answer to your questions instead of this back and forth. I would sincerely appreciate that. 7048805577

CC

Chad Coarsey Tue 16 Oct 2018

@danceupon any chance to call?

E

ebubar Thu 18 Oct 2018

Not sure if it will add to discussion or cause more confusion, but I think this is an extremely well planned academic study for clinically assessing these devices. There is currently not much buy-in from medical professionals on eNABLE devices, I think in part due to a lack of clinically validated data on the use of these hands. I've done some clinical testing in my lab but have been unable find the same sorts of medical partnerships that Chad has developed. This is a truly powerful team that Chad has access to and will, I think, potentially open doors for more medical clinicians to work with eNABLE, as others have mentioned. The funds that Chad is asking for are the equipment costs for getting the SHAP evaluation suite of tools, which is a great set of tools. Its use on eNABLE devices will further demonstrate how eNABLE is working to build useful tools that just happen to also look like awesome toys!. Finding funding sources for these kinds of purchases in academic circles is often quite difficult in my experience. The hospital partner is already putting forth a huge amount of resources, thus I think its a well justified use of some of the eNABLE fund money. This tool will identify how functional eNABLE designs are for a variety of daily use activities and place their use in context with commercial prosthetics, which is a language that O and P's can speak and understand. In that respect, the potential gains from this project are tremendous. Finally, I should note that if its not clear, going through IRB approval for a study like this is quite exhausting and is a MOUNTAIN of work. Exclusion of populations of people from participating in the study is, I suspect, more of a practical matter stemming from the specifics of how applying for IRB approval works. There is no attempt to restrict or limit device use. I assume Chad would happily test anyone, but the identified populations were chosen because that's who they have access to and have expertise to work with.

P

Patrick Thu 18 Oct 2018

LG

Leland Green Thu 18 Oct 2018

This link should work:
http://www.shap.ecs.soton.ac.uk/

P

Patrick Sat 20 Oct 2018

THANK YOU Leland. So many acronyms in my life.

P

Patrick Sat 20 Oct 2018

@chadcoarsey1 I am unfamiliar with Florida, but if you ever wrote "New Articles of Organization" and setup a specific business for this ideal, could you not then DBA as the entity of a similar name? I am not a lawyer I cannot give legal advice.

CC

Chad Coarsey Sat 20 Oct 2018

We have a 501 c3, Adaptive Bionic Devices, inc. d/b/a/ The Bionic Glove Project

P

Patrick Sat 20 Oct 2018

In Massachusetts it is either 2 or 3 years in a row if you do not file an annual...

P

Patrick Sat 20 Oct 2018

This one is NOT a nonprofit, as such, not a 501c?

CC

Chad Coarsey Sat 20 Oct 2018

See my above link

P

Patrick Sat 20 Oct 2018

I see it, but it differs from the proposal. First Paragraph. I just want to make sure I am looking at the correct information.

CC

Chad Coarsey Sat 20 Oct 2018

Thank you

P

Patrick Mon 22 Oct 2018

I am still not sold on the idea. Please be wary of your processes and do understand the name you put behind this.

CC

Chad Coarsey Mon 22 Oct 2018

Thank you for your feedback