Comparison of Pattern Recognition Control and Direct Control in TMR

NCT03097978 | Completed

• 1 other identifier: STU00068547
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Amputation; Amputation; Traumatic, Arm, Upper

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Modified Box and Blocks

  At 1 month, 2 months, 4 months, 6 months

• Jebsen Test of Hand Function

  At 1 month, 2 months, 4 months, 6 months

• Southampton Hand Assessment Procedure (SHAP)

  At 1 month, 2 months, 4 months, 6 months

• ACMC

  At 1 month, 2 months, 4 months, 6 months

Study Arms (4)

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.

Device: RIC arm system; Other: Pattern Recognition

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.

Device: RIC arm system; Other: Direct Control

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.

Device: Commercial system; Other: Pattern Recognition

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.

Device: Commercial system; Other: Direct Control

Interventions

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.

Commercial system with Direct Control; Commercial system with PR control

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.

RIC arm system with direct control; RIC arm system with pattern recognition

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.

Commercial system with Direct Control; RIC arm system with 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.

Commercial system with PR control; RIC arm system with pattern recognition

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 transhumeral or shoulder-disarticulation level
• Successful TMR surgery
• Previous success at operating a myoelectric prosthesis using surface EMG signals from reinnervated muscles (not necessarily current prosthesis usage, although current prosthesis users may be more likely to use their trial prostheses).

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. Of note, all TMR patients to date have normal cognitive function and we are not aware of any new brain injuries that would preclude participation
• 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
• United States Department of Defense: collaborator

Study Sites (1)

Rehabilitation Institute of Chicago

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• 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.

  PMID: 30255800 DERIVED

Study Officials

• Todd Kuiken, MD, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• 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: March 27, 2017
• First Posted: March 31, 2017
• Study Start: June 1, 2013
• Primary Completion: September 29, 2017
• Study Completion: September 29, 2017
• Last Updated: February 23, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)