Amputation; Traumatic, Hand, and WristNCT02349035
Application of Targeted Reinnervation for People With Transradial Amputation
A study of Amputation; Traumatic, Hand, and Wrist and Amputation; Traumatic, Hand, at Wrist Level, run by Shirley Ryan AbilityLab at 3 sites in United States.
Trial summary
The purpose of this study is to improve prosthesis control for transradial amputees with combining targeted muscle reinnervation surgery (TMR) and pattern recognition control. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Amputation; Traumatic, Hand, and Wrist, Amputation; Traumatic, Hand, at Wrist Level
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2014to Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A upper limb amputation at the transradial level
Who cannot join
- Significant new injury that would prevent use of a prosthesis: The ability to consistently wear a prosthesis and perform activities of daily living and specific performance tasks is necessary to evaluate the relative benefits of the interventions.
- Cognitive impairment sufficient to adversely affect understanding of or compliance with study requirements, ability to communicate experiences, or ability to give informed consent: The ability to understand and comply with requirements of the study is essential in order for the study to generate useable, reliable data. The ability to obtain relevant user feedback through questionnaires and informal discussion adds significant value to this study.
- Significant other co morbidity: Any other medical issues or injuries that would preclude completion of the study, use of the prostheses, or that would otherwise prevent acquisition of useable data by researchers
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
Rehabilitation Institute of Chicago
Chicago, Illinois, 60611
San Antonio Military Medical Center
Fort Sam Houston, Texas, 78234
About this study
The purpose of this study is to improve prosthesis control for transradial amputees with combining targeted muscle reinnervation surgery (TMR) and pattern recognition control.
Read the detailed description
Phase 1: Transradial amputees will be asked to come to the Rehabilitation Institute of Chicago, Walter Reed National Military Medical Center or the San Antonio Military Medical Center for initial fitting with a prosthetist for a multifunctional hand system or multifunctional hand and wrist system. The prosthesis system will consist of a custom-made socket and commercially available components. The first visit (up to five days)s involves casting, creating and fitting of a socket that will be used for the study. During the initial and subsequent visits, the subject will be asked asked to practice 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.
Once they receive a socket, they will complete 1-3 days of training to learn how to control the prosthesis with either conventional or pattern recognition control. The prosthetic training days may occur concurrently with the fitting appointment or it may require a separate visit. The subject will return home for the initial 8 week home use trial. They will be asked to use the prosthesis for an average of 2 hours per day across the 8 week home trial period. They will keep a home log of prosthesis use and check in weekly with a therapist to discuss usage and prosthesis performance. They may also be provided with a laptop computer with a camera for Skyping. The laptop can be connected to the prosthesis, and the screen can be viewed remotely. The research team can then continue with remote follow up with more training and problem solving as needed. Directly following the 8 week home trial period, usage data from the prosthesis will be downloaded. The subject will complete 1-3 days of outcomes testing with a therapist. A series of tests will be performed and data recorded of your performance. The subject will then repeat the 1-3 days of training, 8 week home trial period, and 1-3 days of outcomes testing with either the other type of control (i.e. conventional or pattern recognition).
Phase 2: The subject will return to one of the three centers for Targeted Muscle Reinnervation (TMR) surgery. The surgery is an outpatient procedure that will be performed under general anesthesia, consistent with current standard of care. The surgery will involve the transfer of the median nerve to the flexor digitorum superficialis (DFS) muscle and the ulnar nerve will be transferred to the flexor carpi ulnaris (FCU) muscle. Both transfers can be done with a single incision. Alternative target muscles (e.g. the brachioradialis muscle) can be used if trauma interferes with use of the DFS and/or FCU. Some post-operative pain is expected and the subject will be given a prescription for pain medication if needed. Two weeks after the surgery the subject will be asked to start doing exercises to help with muscle recovery. They will return to using the prosthesis from Phase 1 with either conventional or pattern recognition control for 6 months after surgery. Socket adjustments will be made if needed. If they return to using pattern recognition control, their usage and performance data will be tracked during this 6 month period. The subject may be provided with a laptop computer and asked to perform a series of virtual tests. They will receive additional training on how to complete these tests. If the subject returns to using conventional control, they will not be asked to complete the additional tests, nor will the usage or performance data be tracked. Six months after surgery, when reinnervation of the target muscles has been completed, the subject will return to using the prosthesis with pattern recognition control. They will be asked to return to one of the three centers if socket adjustments or a replacement socket is needed. The subject will receive 1-3 days of pattern recognition control training, only this time special attention will be paid to utilizing EMG from target muscles for improved function. Preliminary testing will be done to ensure that they can adequately use the prosthesis. The subject will then take the prosthesis home for a third 8-week home-use trial. The subject will be asked to log daily use of the device, note any issues, and follow up weekly with a therapist. After this home-use trial, the same 1-3 days of comprehensive outcomes testing will be completed and usage data from their prostheses will be downloaded.
Finally, the subject will continue using the prostheses at home for an additional 3-4 months. No usage requirements will be given during this time. At the end of this 3-4 month period (approximately 12 months after surgery), they will have a final round of 1-3 days of testing with the complete toolbox and data from the prosthesis will be downloaded.
The days of prosthesis training and testing may take place at the Rehabilitation Institute of Chicago, Walter Reed National Military Medical Center, or the San Antonio Military Medical Center or near your home. Study coordinators will determine the best location.
- Being tested
- Compare control of multifunction transradial prosthesis, Perform TMR surgery and evaluate transradial TMR pattern recognition control of multifunctional prostheses.
- Keywords
- Transradial amputee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compare control of multifunction transradial prosthesisDevice
Subjects practice control methods using a VR system. EMG data and virtual games are used and provide data to assess control methods without prosthesis. Subjects are fit with commercially available multifunctional hand system. They receive 1-3 days of training for conventional or pattern recognition control. They return home for an 8 week trial. They use the prosthesis for 2 hours a day across the 8 week trial. They keep a log of use and check with a therapist about usage and performance. After the 8 week trial, data from the prosthesis is downloaded. The subject will complete 1-3 days of outcomes testing. They perform a series of tests and data is recorded. The subject will repeat the 1-3 days of training, 8 week home trial, and 1-3 days of outcomes testing with either type of control.
Perform TMR surgery and evaluate transradial TMR pattern recognition control of multifunctional prostheses.Procedure or surgery
Subject has Targeted Muscle Reinnervation surgery. The surgery transfers median nerve to flexor digitorum superficialis muscle and ulnar nerve to flexor carpi ulnaris muscle. Two weeks after surgery, exercises start for muscle recovery. Then return to prosthesis from Phase 1 for 6 months. If they have pattern recognition control, usage and performance will be tracked for 6 months. If they return to conventional control, they will not complete tests, track usage, or performance. Six months after surgery, they return to pattern recognition control. Receive 1-3 days of training. Take prosthesis home for 8 week trial. Log use of device, note issues, and follow up with therapist. After home trial, 1-3 days of outcomes testing are completed and usage data downloaded. Continue using their prostheses for an additional 3-4 months. At 12 months after surgery, a final round of 1-3 days of testing and data are downloaded.
| Study group | Role | What they receive |
|---|---|---|
| TMR surgery to evaluate pattern recognition control | Experimental | Perform Targeted Muscle Reinnervation (TMR) surgery and evaluate transradial TMR pattern recognition control of multifunctional prostheses. Receives: Device: Compare control of multifunction transradial prosthesis; Procedure: Perform TMR surgery and evaluate transradial TMR pattern recognition control of multifunctional prostheses. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improve pattern recognition control of multifunction prostheses for transradial amputees.
Improved control of prosthesis as seen through functional use improvements.
Measured: 15 months from initial enrollment
Secondary outcomes (9)
Modified Box and Blocks
Timed task to assess prosthetic control.
Measured: At 2 and 4 months pre-op; At 6 and 10 months post-op
Clothespin Relocation Test
Timed task to assess prosthetic control.
Measured: At 2 and 4 months pre-op; At 6 and 10 months post-op
ACMC
Assessment of capacity for myoelectric prosthetic control
Measured: At 2 and 4 months pre-op; At 6 and 10 months post-op
Jebsen Test of Hand Function
7 part timed diagnostic test to determine the level of hand function.
Measured: At 2 and 4 months pre-op; At 6 and 10 months post-op
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.
Measured: At 2 and 4 months pre-op; At 6 and 10 months post-op
OPUS-UEFS
An instrument that evaluates the activity limitations, quality of life, and patient satisfaction with services and devices.
Measured: At 2 and 4 months pre-op; At 6 and 10 months post-op
Activities Measure for Upper Limb Amputees (AM-ULA)
A clinician rated measure of an upper limb amputee's performance of daily functional activities using a prosthesis.
Measured: At 2 and 4 months pre-op; At 6 and 10 months post-op
TAC TEST/ Motion Test
Virtual reality testing of classification accuracy, motion completion rate, motion completion time and path efficiency.
Measured: At 2 and 4 months pre-op; At 6 and 10 months post-op
PSFS
Used to assess functional ability to complete specific activities
Measured: At 2 and 4 months pre-op; At 6 and 10 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study startDec 2014
- Primary completionDec 2020
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amputation; Traumatic, Hand, and WristStudies of the same condition, open and under way.
- More trials run by Shirley Ryan AbilityLabThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Collaborators
- Walter Reed National Military Medical Center, San Antonio Military Medical Center, Northwestern University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Todd Kuiken, Shirley Ryan AbilityLab
- Investigators
- Todd A Kuiken, MD, PhD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02349035
- Sponsor's protocol ID
- STU00101444
- Other IDs
- R01HD081525-01
- Status last verified
- May 2021
- First submitted
- 9 Jan 2015
- Last updated
- 13 May 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Targeted Reinnervation for People With Transradial Amputation
- ClinicalTrials.gov ID
- NCT02349035
- Acronym / sponsor ID
- STU00101444
- Keywords
- Transradial amputee
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Collaborators
- Walter Reed National Military Medical Center, San Antonio Military Medical Center, Northwestern University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Dec 2014
- Primary completion
- Dec 2020 (actual)
- Study completion
- Jan 2022 (estimated)
- First posted
- 28 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to improve prosthesis control for transradial amputees with combining targeted muscle reinnervation surgery (TMR) and pattern recognition control.
Detailed description
Phase 1: Transradial amputees will be asked to come to the Rehabilitation Institute of Chicago, Walter Reed National Military Medical Center or the San Antonio Military Medical Center for initial fitting with a prosthetist for a multifunctional hand system or multifunctional hand and wrist system. The prosthesis system will consist of a custom-made socket and commercially available components. The first visit (up to five days)s involves casting, creating and fitting of a socket that will be used for the study. During the initial and subsequent visits, the subject will be asked asked to practice 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.
Once they receive a socket, they will complete 1-3 days of training to learn how to control the prosthesis with either conventional or pattern recognition control. The prosthetic training days may occur concurrently with the fitting appointment or it may require a separate visit. The subject will return home for the initial 8 week home use trial. They will be asked to use the prosthesis for an average of 2 hours per day across the 8 week home trial period. They will keep a home log of prosthesis use and check in weekly with a therapist to discuss usage and prosthesis performance. They may also be provided with a laptop computer with a camera for Skyping. The laptop can be connected to the prosthesis, and the screen can be viewed remotely. The research team can then continue with remote follow up with more training and problem solving as needed. Directly following the 8 week home trial period, usage data from the prosthesis will be downloaded. The subject will complete 1-3 days of outcomes testing with a therapist. A series of tests will be performed and data recorded of your performance. The subject will then repeat the 1-3 days of training, 8 week home trial period, and 1-3 days of outcomes testing with either the other type of control (i.e. conventional or pattern recognition).
Phase 2: The subject will return to one of the three centers for Targeted Muscle Reinnervation (TMR) surgery. The surgery is an outpatient procedure that will be performed under general anesthesia, consistent with current standard of care. The surgery will involve the transfer of the median nerve to the flexor digitorum superficialis (DFS) muscle and the ulnar nerve will be transferred to the flexor carpi ulnaris (FCU) muscle. Both transfers can be done with a single incision. Alternative target muscles (e.g. the brachioradialis muscle) can be used if trauma interferes with use of the DFS and/or FCU. Some post-operative pain is expected and the subject will be given a prescription for pain medication if needed. Two weeks after the surgery the subject will be asked to start doing exercises to help with muscle recovery. They will return to using the prosthesis from Phase 1 with either conventional or pattern recognition control for 6 months after surgery. Socket adjustments will be made if needed. If they return to using pattern recognition control, their usage and performance data will be tracked during this 6 month period. The subject may be provided with a laptop computer and asked to perform a series of virtual tests. They will receive additional training on how to complete these tests. If the subject returns to using conventional control, they will not be asked to complete the additional tests, nor will the usage or performance data be tracked. Six months after surgery, when reinnervation of the target muscles has been completed, the subject will return to using the prosthesis with pattern recognition control. They will be asked to return to one of the three centers if socket adjustments or a replacement socket is needed. The subject will receive 1-3 days of pattern recognition control training, only this time special attention will be paid to utilizing EMG from target muscles for improved function. Preliminary testing will be done to ensure that they can adequately use the prosthesis. The subject will then take the prosthesis home for a third 8-week home-use trial. The subject will be asked to log daily use of the device, note any issues, and follow up weekly with a therapist. After this home-use trial, the same 1-3 days of comprehensive outcomes testing will be completed and usage data from their prostheses will be downloaded.
Finally, the subject will continue using the prostheses at home for an additional 3-4 months. No usage requirements will be given during this time. At the end of this 3-4 month period (approximately 12 months after surgery), they will have a final round of 1-3 days of testing with the complete toolbox and data from the prosthesis will be downloaded.
The days of prosthesis training and testing may take place at the Rehabilitation Institute of Chicago, Walter Reed National Military Medical Center, or the San Antonio Military Medical Center or near your home. Study coordinators will determine the best location.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TMR surgery to evaluate pattern recognition control | Experimental | Device: Compare control of multifunction transradial prosthesis, Procedure: Perform TMR surgery and evaluate transradial TMR pattern recognition control of multifunctional prostheses.Perform Targeted Muscle Reinnervation (TMR) surgery and evaluate transradial TMR pattern recognition control of multifunctional prostheses. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- A upper limb amputation at the transradial level
Key exclusion criteria (3 listed)
- Significant new injury that would prevent use of a prosthesis: The ability to consistently wear a prosthesis and perform activities of daily living and specific performance tasks is necessary to evaluate the relative benefits of the interventions.
- Cognitive impairment sufficient to adversely affect understanding of or compliance with study requirements, ability to communicate experiences, or ability to give informed consent: The ability to understand and comply with requirements of the study is essential in order for the study to generate useable, reliable data. The ability to obtain relevant user feedback through questionnaires and informal discussion adds significant value to this study.
- Significant other co morbidity: Any other medical issues or injuries that would preclude completion of the study, use of the prostheses, or that would otherwise prevent acquisition of useable data by researchers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compare control of multifunction transradial prosthesisSubjects practice control methods using a VR system. EMG data and virtual games are used and provide data to assess control methods without prosthesis. Subjects are fit with commercially available multifunctional hand system. They receive 1-3 days of training for conventional or pattern recognition control. They return home for an 8 week trial. They use the prosthesis for 2 hours a day across the 8 week trial. They keep a log of use and check with a therapist about usage and performance. After the 8 week trial, data from the prosthesis is downloaded. The subject will complete 1-3 days of outcomes testing. They perform a series of tests and data is recorded. The subject will repeat the 1-3 days of training, 8 week home trial, and 1-3 days of outcomes testing with either type of control. | Device | TMR surgery to evaluate pattern recognition control |
| Perform TMR surgery and evaluate transradial TMR pattern recognition control of multifunctional prostheses.Subject has Targeted Muscle Reinnervation surgery. The surgery transfers median nerve to flexor digitorum superficialis muscle and ulnar nerve to flexor carpi ulnaris muscle. Two weeks after surgery, exercises start for muscle recovery. Then return to prosthesis from Phase 1 for 6 months. If they have pattern recognition control, usage and performance will be tracked for 6 months. If they return to conventional control, they will not complete tests, track usage, or performance. Six months after surgery, they return to pattern recognition control. Receive 1-3 days of training. Take prosthesis home for 8 week trial. Log use of device, note issues, and follow up with therapist. After home trial, 1-3 days of outcomes testing are completed and usage data downloaded. Continue using their prostheses for an additional 3-4 months. At 12 months after surgery, a final round of 1-3 days of testing and data are downloaded. | Procedure or surgery | TMR surgery to evaluate pattern recognition control |
Primary outcome
Improve pattern recognition control of multifunction prostheses for transradial amputees.
Time frame: 15 months from initial enrollment
Improved control of prosthesis as seen through functional use improvements.
9 secondary outcomes
Modified Box and Blocks
Time frame: At 2 and 4 months pre-op; At 6 and 10 months post-op
Clothespin Relocation Test
Time frame: At 2 and 4 months pre-op; At 6 and 10 months post-op
ACMC
Time frame: At 2 and 4 months pre-op; At 6 and 10 months post-op
Jebsen Test of Hand Function
Time frame: At 2 and 4 months pre-op; At 6 and 10 months post-op
Southampton Hand Assessment Procedure (SHAP)
Time frame: At 2 and 4 months pre-op; At 6 and 10 months post-op
OPUS-UEFS
Time frame: At 2 and 4 months pre-op; At 6 and 10 months post-op
Activities Measure for Upper Limb Amputees (AM-ULA)
Time frame: At 2 and 4 months pre-op; At 6 and 10 months post-op
TAC TEST/ Motion Test
Time frame: At 2 and 4 months pre-op; At 6 and 10 months post-op
PSFS
Time frame: At 2 and 4 months pre-op; At 6 and 10 months post-op
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Todd A Kuiken, MD, PhD principal investigator
Shirley Ryan AbilityLab
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Amputation; Traumatic, Hand, and Wrist and Amputation; Traumatic, Hand, at Wrist Level, run by Shirley Ryan AbilityLab at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improve pattern recognition control of multifunction prostheses for transradial amputees. (time frame: 15 months from initial enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2021.