Effects of Myoelectric Channel Count and Targeting for Upper Limb Prosthetic Control

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)
• Amputation; Traumatic, Arm: Forearm, Between Elbow and Wrist

Interventions

DEVICE

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.

DEVICE

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.

DEVICE

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.

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

• Liberating Technologies, Inc.

  lead INDUSTRY

Principal Investigators

• Todd Farrell, PhD · Liberating Technologies, Inc.

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-31

Primary Completion

2026-06-30

Completion

2026-06-30

FDA Device

Yes

Countries

• United States

Study Locations