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Application of Targeted Reinnervation for People With Transradial Amputation

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ClinicalTrials.gov Identifier: NCT02349035
Recruitment Status : Active, not recruiting
First Posted : January 28, 2015
Last Update Posted : August 14, 2019
Sponsor:
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)
Information provided by (Responsible Party):
Todd Kuiken, Shirley Ryan AbilityLab

Brief 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.

Condition or disease Intervention/treatment Phase
Amputation; Traumatic, Hand, and Wrist Amputation; Traumatic, Hand, at Wrist Level Device: Compare control of multifunction transradial prosthesis Procedure: Perform TMR surgery and evaluate transradial TMR pattern recognition control of multifunctional prostheses. Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Application of Targeted Reinnervation for People With Transradial Amputation
Study Start Date : December 2014
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TMR surgery to evaluate pattern recognition control
Perform Targeted Muscle Reinnervation (TMR) surgery and evaluate transradial TMR pattern recognition control of multifunctional prostheses.
Device: Compare control of multifunction transradial prosthesis
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.

Procedure: 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Modified Box and Blocks [ Time Frame: At 2 and 4 months pre-op; At 6 and 10 months post-op ]
    Timed task to assess prosthetic control.

  2. Clothespin Relocation Test [ Time Frame: At 2 and 4 months pre-op; At 6 and 10 months post-op ]
    Timed task to assess prosthetic control.

  3. ACMC [ Time Frame: At 2 and 4 months pre-op; At 6 and 10 months post-op ]
    Assessment of capacity for myoelectric prosthetic control

  4. Jebsen Test of Hand Function [ Time Frame: At 2 and 4 months pre-op; At 6 and 10 months post-op ]
    7 part timed diagnostic test to determine the level of hand function.

  5. Southampton Hand Assessment Procedure (SHAP) [ Time Frame: At 2 and 4 months pre-op; At 6 and 10 months post-op ]
    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.

  6. OPUS-UEFS [ Time Frame: At 2 and 4 months pre-op; At 6 and 10 months post-op ]
    An instrument that evaluates the activity limitations, quality of life, and patient satisfaction with services and devices.

  7. Activities Measure for Upper Limb Amputees (AM-ULA) [ Time Frame: At 2 and 4 months pre-op; At 6 and 10 months post-op ]
    A clinician rated measure of an upper limb amputee's performance of daily functional activities using a prosthesis.

  8. TAC TEST/ Motion Test [ Time Frame: At 2 and 4 months pre-op; At 6 and 10 months post-op ]
    Virtual reality testing of classification accuracy, motion completion rate, motion completion time and path efficiency.

  9. PSFS [ Time Frame: At 2 and 4 months pre-op; At 6 and 10 months post-op ]
    Used to assess functional ability to complete specific activities



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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A upper limb amputation at the transradial level

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02349035


Locations
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United States, Illinois
Rehabilitation Institute of Chicago
Chicago, Illinois, United States, 60611
United States, Maryland
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889
United States, Texas
San Antonio Military Medical Center
Fort Sam Houston, Texas, United States, 78234
Sponsors and Collaborators
Shirley Ryan AbilityLab
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)
Investigators
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Principal Investigator: Todd A Kuiken, MD, PhD Shirley Ryan AbilityLab

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Responsible Party: Todd Kuiken, Director, Center for Bionic Medicine, Shirley Ryan AbilityLab
ClinicalTrials.gov Identifier: NCT02349035     History of Changes
Other Study ID Numbers: STU00101444
R01HD081525-01 ( U.S. NIH Grant/Contract )
First Posted: January 28, 2015    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Keywords provided by Todd Kuiken, Shirley Ryan AbilityLab:
Transradial amputee
Additional relevant MeSH terms:
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Amputation, Traumatic
Wounds and Injuries