Application of Targeted Reinnervation for People With Transradial Amputation

NCT02349035 | Unknown

• 2 other identifiers: STU00101444R01HD081525-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 3

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.

Conditions

Amputation; Traumatic, Hand, and Wrist; Amputation; Traumatic, Hand, at Wrist Level

Keywords

Transradial amputee

Outcome Measures

Primary Outcomes (1)

• Improve pattern recognition control of multifunction prostheses for transradial amputees.

  Improved control of prosthesis as seen through functional use improvements.

  15 months from initial enrollment

Secondary Outcomes (9)

• Modified Box and Blocks

  At 2 and 4 months pre-op; At 6 and 10 months post-op

• Clothespin Relocation Test

  At 2 and 4 months pre-op; At 6 and 10 months post-op

• ACMC

  At 2 and 4 months pre-op; At 6 and 10 months post-op

• Jebsen Test of Hand Function

  At 2 and 4 months pre-op; At 6 and 10 months post-op

• Southampton Hand Assessment Procedure (SHAP)

  At 2 and 4 months pre-op; At 6 and 10 months post-op

Study Arms (1)

TMR surgery to evaluate pattern recognition control

EXPERIMENTAL

Perform Targeted Muscle Reinnervation (TMR) surgery and evaluate transradial TMR pattern recognition control of multifunctional prostheses.

Device: Compare control of multifunction transradial prosthesis; Procedure: Perform TMR surgery and evaluate transradial TMR pattern recognition control of multifunctional prostheses.

Interventions

Compare control of multifunction transradial prosthesis DEVICE

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.

TMR surgery to evaluate pattern recognition control

Perform TMR surgery and evaluate transradial TMR pattern recognition control of multifunctional prostheses. PROCEDURE

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.

TMR surgery to evaluate pattern recognition control

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A upper limb amputation at the transradial level

You may not qualify if:

• 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

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead
• Walter Reed National Military Medical Center: collaborator
• San Antonio Military Medical Center: collaborator
• Northwestern University: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (3)

Rehabilitation Institute of Chicago

Chicago, Illinois, 60611, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

San Antonio Military Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

Study Officials

• Todd A Kuiken, MD, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Bionic Medicine

Study Record Dates

• First Submitted: January 9, 2015
• First Posted: January 28, 2015
• Study Start: December 1, 2014
• Primary Completion: December 1, 2020
• Study Completion: January 1, 2022
• Last Updated: May 13, 2021

Record last verified: 2021-05

Locations

US (3)