Optimize Pattern Recognition Control of Powered Upper Limb Prosthesis

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

About this trial

This study is focused on optimizing methods for controlling upper-limb myoelectric prosthetic arms. If you are enrolled in this study you would be expected to visit one of the research sites for approximately 5 in-lab visits lasting about 4 hours. These visits are expected to happen within a 5-week period but may take longer depending on scheduling availability. During these visits you will be completing basic tasks similar to your everyday actions using a prosthetic arm that is provided for you.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 years or older

Unilateral transradial level limb difference

Current or past user of myo-electric controlled prostheses

Six months or more post-amputation

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 that would 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.

Significant other comorbidity: 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.

Pregnant participants as risk to pregnant individuals, embryos, or fetuses are not understood.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Condition A: Electrode Configuration

    Device

    Each intervention is a specific blinded number and location of electrodes within the prosthetic arm used to control the prosthetic arm with pattern recognition myoelectric control.

  • Condition B: Electrode Configuration

    Device

    Each intervention is a specific blinded number and location of electrodes within the prosthetic arm used to control the prosthetic arm with pattern recognition myoelectric control.

  • Condition C: Electrode Configuration

    Device

    Each intervention is a specific blinded number and location of electrodes within the prosthetic arm used to control the prosthetic arm with pattern recognition myoelectric control.

  • Condition D: Electrode Configuration

    Device

    Each intervention is a specific blinded number and location of electrodes within the prosthetic arm used to control the prosthetic arm with pattern recognition myoelectric control.

Treatment groups

32 Participants
are divided into 4 treatment groups
Group A: Sequence 1Experimental treatment 4 interventions
Group B: Sequence 2Experimental treatment 4 interventions
Group C: Sequence 3Experimental treatment 4 interventions
Group D: Sequence 4Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

ACMC

The participant will complete a daily task (such as packing a suitcase) using their prosthetic arm. A study occupational therapist will score the participants ability along different metrics.

Time frame
Through study completion, an average of 1 month, 1 time at each 4 site visits.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Liberating Technologies, Inc.

Lead sponsor

Shirley Ryan AbilityLab

Collaborator

University of Hartford

Collaborator