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Regulatory Clearance of the Glide Control Strategy for Upper Limb Prostheses

RecruitingNAAges 18 Years - anyAllInfinite Biomedical Technologies
NCT06539936 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The investigators will test the following hypothesis: Use of Glide results in improved functional performance, satisfaction, and usage metrics as compared to use of a standard Direct Control (DC) prosthesis. This study will compare the use of Glide \[Experimental\] prosthesis with a DC \[Standard\] prosthesis in a clinical setting and in unsupervised daily activity. We will follow a multiple baseline design, specifically an AB design. Each of the subjects will use the Experimental and Standard systems over a total of 24-weeks. The A phase is the baseline phase where the DC prosthesis will be used, and the B phase will be the treatment phase where the Glide prosthesis will be used. Participants will undergo an A phase of either 10-weeks, 12-weeks, or 14-weeks duration, with the remaining 14-, 12-, or 10-weeks of the study being dedicated to the B phase.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Trans-radial unilateral limb loss * Candidate for a multi-articulated myoelectric hand prosthesis as determined by the study prosthetist * Minimal residual limb length for myoelectric control as determined by the clinical team * Age of 18 years or greater Exclusion Criteria: * Patients with a residual limb that is unhealed from the amputation surgery * Patients with easily damaged or sensitive skin who would not tolerate EMG electrodes * Unhealed wounds * Significant cognitive deficits as determined upon clinical evaluation * Significant neurological deficits as determined upon clinical evaluation * Significant physical deficits of the residual limb impacting full participation in the study as determined upon clinical evaluation * Uncontrolled pain or phantom pain impacting full participation in the study as determined upon clinical evaluation * Serious uncontrolled medical problems as judged by the project therapist
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What it tests

  • Glide
  • Direct Control
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Where

1 site
Advanced Arm Dynamics
Redondo Beach, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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