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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLiberating Technologies, Inc.

About this trial

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

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • 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

Treatment groups

32 Participants
are divided into 5 treatment groups

Sponsors and collaborators