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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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Targeted Muscle Reinnervation increases the control signals available for commercial arm systems. A new type of control, pattern recognition, has been developed into a form that allows use with commercially available arm system. The goal of this project is a home trial, in which people who have had TMR will try the new controls and the new arm to find out if they are better than what is currently available. Home trials will also allow us to see what needs to be done to make our inventions work even better.
Subjects who participate return to RIC several times (approximately 6-8 times) to undergo any necessary training and testing. Each visit will last from 2-5 days. The study will include use of up to three different prosthesis control systems at home for approximately 6 weeks each. The order of the systems will be randomized.
The first visit will allow us to cast the subject's residual limb for a socket and measure for a gel liner to be made with embedded electrode contacts prior to the next return. The socket interface will be fit for optimal comfort and a suspension sleeve and/or other straps, fasters, etc to best hold the prosthesis securely on the residual limb for the activities required. Unless changes are needed due to changes in limb volume, the same socket can be used for all phases of the study. During the initial and subsequent visits, subjects may practice the various control methods using a virtual reality system. EMG data and virtual "games" will be used to practice the control and will provide quantitative data that can be used to assess the various control methods mathematically, without the prosthesis.
Each phase of the study (up to 4 phases), will include preliminary training and testing at RIC lasting for 1-5 days, followed by approximately 6 weeks of at-home use of the system. After this time subjects will return to the RIC for 2-3 days of testing. They will then be trained and pre-tested in use of the next control during the same visit or at a later date. These systems include a commercially available myoelectric prosthesis with standard control, a commercially available device with advanced control (called pattern recognition), a commercially available device with pattern recognition and a new electrode configuration. Photographs or video recordings will be made during participation in this research study. These pictures and video recordings are essential for proper data analysis.
During the at-home use periods subjects will go about their daily business using the test prosthesis and will be asked document the experience with the prosthesis via weekly phone communication with study staff. Dates/times will be coordinated during normal business hours At the end of the at-home use period subjects will return to RIC for 3-5 days, where they will be asked to complete a questionnaire about how the prosthesis worked, and will undergo some non-invasive testing to see how well they can control and use the prosthesis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RIC arm system with pattern recognition | Experimental | Subject will be fit with a custom socket and receive training on pattern recognition with the RIC arm prosthesis. Once appropriate training has occurred, outcome measures will be completed followed by a home trial for at least 6 weeks with the device. Outcome measures will be collected at the conclusion of the 6 week home trial. |
|
| RIC arm system with direct control | Experimental | Subject will be fit with a custom socket and receive training on direct control with the RIC arm prosthesis. Once appropriate training has occurred, outcome measures will be completed followed by a home trial for at least 6 weeks with the device. Outcome measures will be collected at the conclusion of the 6 week home trial. |
|
| Commercial system with PR control | Experimental | Subject will be fit with a custom socket and receive training on pattern recognition with a conventional, commercial prosthesis system. Once appropriate training has occurred, outcome measures will be completed followed by a home trial for at least 6 weeks with the device. Outcome measures will be collected at the conclusion of the 6 week home trial. |
|
| Commercial system with Direct Control | Experimental | Subject will be fit with a custom socket and receive training on direct control with a conventional, commercial prosthesis system. Once appropriate training has occurred, outcome measures will be completed followed by a home trial for at least 6 weeks with the device. Outcome measures will be collected at the conclusion of the 6 week home trial. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Commercial system | Device | Transhumeral amputees who have had TMR will use a commercially available prosthesis with an elbow,wrist, and a hand with custom electronics and software for both direct and pattern recognition - based control. |
| Measure | Description | Time Frame |
|---|---|---|
| Pattern recognition and the RIC arm system will demonstrate a significant improvement over exiting technology. | Improved control of prosthesis as seen through functional use improvements. | 15 months from initial enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Box and Blocks | Timed task to assess prosthetic control. | At 1 month, 2 months, 4 months, 6 months |
| Jebsen Test of Hand Function | 7 part timed diagnostic test to determine the level of hand function |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Todd Kuiken, MD, PhD | Shirley Ryan AbilityLab | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rehabilitation Institute of Chicago | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30255800 | Derived | Hargrove L, Miller L, Turner K, Kuiken T. Control within a virtual environment is correlated to functional outcomes when using a physical prosthesis. J Neuroeng Rehabil. 2018 Sep 5;15(Suppl 1):60. doi: 10.1186/s12984-018-0402-y. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 16, 2019 | |
| Reset | Jun 4, 2019 | |
| Release | Aug 15, 2019 | |
| Reset | Sep 4, 2019 | |
| Release | Mar 19, 2020 | |
| Reset | Apr 2, 2020 | |
| Release | Oct 27, 2020 | |
| Reset | Nov 17, 2020 | |
| Release | Jan 15, 2021 | |
| Reset | Feb 2, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 16, 2019 | Jun 4, 2019 | |||
| Aug 15, 2019 |
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| RIC arm system | Device | Transhumeral amputees who have had TMR will use the RIC arm system prosthesis with an elbow,wrist, and a hand with custom electronics and software for both direct and pattern recognition - based control. |
|
| Direct Control | Other | Transhumeral amputees who have had TMR will use either a commercially available prosthesis or the RIC arm system prosthesis with an elbow,wrist, and a hand with custom electronics and software for both direct control. |
|
| Pattern Recognition | Other | Transhumeral amputees who have had TMR will use either a commercially available prosthesis or the RIC arm system prosthesis with an elbow,wrist, and a hand with custom electronics and software for pattern recognition control. |
|
| At 1 month, 2 months, 4 months, 6 months |
| Southampton Hand Assessment Procedure (SHAP) | The test consists of the manipulation of a series of both lightweight and heavyweight abstract objects. The procedure is designed to provide a score of functionality. | At 1 month, 2 months, 4 months, 6 months |
| ACMC | Assessment of capacity for myoelectric prosthetic control | At 1 month, 2 months, 4 months, 6 months |
| Sep 4, 2019 |
| Mar 19, 2020 | Apr 2, 2020 |
| Oct 27, 2020 | Nov 17, 2020 |
| Jan 15, 2021 | Feb 2, 2021 |