NCT07011420 Effects of Myoelectric Channel Count and Targeting for Upper Limb Prosthetic Control

Eligibility & Interventions

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This trial targets 32 participants in total. It began in 2025-10 with a primary completion date of 2026-06.

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.

Eligibility Criteria

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.

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