Application of Targeted Reinnervation for People With Transradial Amputation

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

Interventions

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.

Sponsors & Collaborators

• Walter Reed National Military Medical Center

  collaborator FED

• San Antonio Military Medical Center

  collaborator FED

• Northwestern University

  collaborator OTHER

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• Shirley Ryan AbilityLab

  lead OTHER

Principal Investigators

• Todd A Kuiken, MD, PhD · Shirley Ryan AbilityLab

Study Design

Allocation

NA

Purpose

BASIC_SCIENCE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

95 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-12-31

Primary Completion

2020-12-31

Completion

2022-01-31

Countries

• United States

Study Locations