Recruiting

Myoelectric Channels

Sponsor:

Liberating Technologies, Inc.

Code:

NCT07011420

Conditions

Amputation

Amputation, Traumatic

Amputation, Congenital

Prosthesis User

Upper Limb Amputation Below Elbow (Injury)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Experimental socket with 4 untargeted channels active

Experimental socket with 8 untargeted channels active

Experimental socket with up to 16 untargeted channels active

Experimental socket with 8 targeted channels active

Coapt EMG Cuff

Study Details

Brief summary:

The goal of this clinical trial is to systematically evaluate whether or not two commonly held fundamental assumptions for pattern recognition control translates to functional performance when tested on individuals aged 18 years or older with upper limb absence at the transradial level while wearing a physical prosthesis.

The specific aims of this study are:

1. To evaluate the effect of changing untargeted myoelectric channel count on the functional performance of transradial prosthesis users wearing a fully functional prosthesis via functional outcomes measures such as the Box and Blocks test.
2. To evaluate the effect of changing myoelectric channel targeting of a fixed number of myoelectric channels on the functional performance of transradial prosthesis users wearing a fully functional prosthesis via functional outcomes measures such as the Box and Blocks test.

Researchers will perform a randomized crossover study to compare system configurations with different number of sensor channels and with various strategies for sensor placement on the limb. Participants will be assigned to a random test sequence that includes the following four different EMG channel conditions:

Condition A: 4 untargeted channels Condition B: 8 untargeted channels Condition C: Up to 16 untargeted channels Condition D: 8 targeted channels

Researchers will evaluate the effects of changing myoelectric channel counts on the functional prosthesis performance of individuals with transradial limb loss via functional outcome measures.

Participants will:

  • Attend up to 5 in-lab sessions that are expected to last 4 hours.
  • Conduct site visits every 1-2 weeks to complete functional and self reported outcome measures with each condition.
  • Play virtual games with the Coapt Cuff for 15 minutes a day, 3 days a week in between visits.

Conditions

Amputation

Amputation, Traumatic

Amputation, Congenital

Prosthesis User

Upper Limb Amputation Below Elbow (Injury)

Study ID

NCT07011420

Start date

Oct, 2025

Status verified date

Sep, 2025

Completion date

Jun, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Unilateral transradial level limb absence
  • Current or past user of myo-electric controlled prostheses
  • Six months or more post-amputation
  • Have adequate limb length such that a wrist rotation device can fit in the check socket
  • Well-fitting socket as determined by a Socket-Comfort Score of 6 or above
  • Capable of wearing and operating a prosthesis with a wrist rotator and multi-articulating hand
  • Capable of understanding and following multi-step instructions and completing the tasks as described
  • English speaking

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 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.

Study Design

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Condition A: 4 untargeted channels

The 4-channel untargeted condition (Condition A) will utilize every fourth channel, and their location will be targeted at positions that are 'on the 45s' when examining a cross section of the forearm with the elbow bent to 90 degrees and the thumb pointed up.

This condition is conducted and completed during a site visit. Outcome measures will be conducted to assess functional outcomes and self-report measures.

experimental: Condition B: 8 untargeted channels

The 8-channel condition (Condition B) will use the same channels as the 4-channel condition but add the four channels that bisect the original four channels.

This condition is conducted and completed during a site visit. Outcome measures will be conducted to assess functional outcomes and self-report measures.

experimental: Condition C: Up to 16 untargeted channels

The 16-channel untargeted condition (Condition C) will utilize all 16 electrodes. Due to different limb sizes a full singular ring of 16 channels may not be possible on all human subjects. In these situations, the clinicians fabricating will use their best clinical judgement in order to fit as many electrode channels as possible onto the arm. If there is no reasonable way to fit 16 channels within the socket, then the maximum possible number of channels will be placed in the socket and the "16-channel" condition will be completed with the maximum number of available channels.

This condition is conducted and completed during a site visit. Outcome measures will be conducted to assess functional outcomes and self-report measures.

active comparator: Condition D: 8 targeted channels

This socket will use 8 targeted EMG channels identified and marked by the study prosthetist using Coapt's clinical instructions for identifying electrode sites. This condition is conducted and completed during a site visit. Outcome measures will be conducted to assess functional outcomes and self-report measures.

other: At-home Pattern Recognition Practice

The subject will use a commercially available EMG Coapt Cuff to practice pattern recognition while at home between study visits. They will be asked to play virtual games with the Coapt Cuff for 15 minutes a day, 3 days a week in between visits. The time between visits will be based on scheduling availability of the participant and study team but is expected to be approximately 1-2 weeks.

Interventions

Experimental socket with 4 untargeted channels active

Participants will utilize the experimental socket made with untargeted EMG channels. Untargeted sites will ideally be located by creating a band of electrode pairs at the largest muscular circumference distal to the elbow. Only 4 channels will be active during this condition.

Experimental socket with 8 untargeted channels active

Participants will utilize the experimental socket made with untargeted EMG channels. Untargeted sites will ideally be located by creating a band of electrode pairs at the largest muscular circumference distal to the elbow. Only 8 channels will be active during this condition.

Experimental socket with up to 16 untargeted channels active

Participants will utilize the experimental socket made with untargeted EMG channels. Untargeted sites will ideally be located by creating a band of electrode pairs at the largest muscular circumference distal to the elbow. All16 channels (or the maximum number of channels based on limb size) will be active during this condition.

Experimental socket with 8 targeted channels active

Participants will utilize the experimental socket made with targeted EMG channels. This socket will follow Coapt's clinical instructions for targeted site location to identify and mark locations for 8 targeted EMG channels.

Coapt EMG Cuff

This device is the commercially available Coapt EMG Cuff. This armband cuff with electrodes can be strapped onto the user's arm to connect with the Coapt app and play virtual games with their EMG signals.

Primary outcome measure

  • The Assessment of Capacity for Myoelectric Control (ACMC) [ Time Frame: 4 hours ]

Central Contacts and Locations

Central contacts

Brianna Rozell

774-233-0876brianna.rozell@liberatingtech.com

Craig Kelly

774.233.0878craig.kelly@liberatingtech.com

Locations

Shirley Ryan AbilityLab

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Laura Miller, PhD

312-238-1000lmiller1@sralab.org

More Information

Sponsor

Liberating Technologies, Inc.

Last update posted

Sep 3, 2025

Last verified

Sep, 2025

Keywords

  • amputee
  • upper limb amputee
  • transradial amputee
  • prosthetic arm
  • upper limb prosthesis user

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Liberating Technologies, Inc. on 2025-09-03.