Regulatory Clearance of the Glide Control Strategy for Upper Limb Prostheses

Recruiting now · Not applicable

Conditions studied: Amputation, Upper Limb

In brief

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.

Key facts

Study ID

NCT06539936

Run by

Infinite Biomedical Technologies

People needed

7

Starts

2024-09-16

Expected to finish

2027-03-31

Last updated by the study team

2026-05-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Advanced Arm Dynamics — Redondo Beach, California, United States (enrolling)

Full record on ClinicalTrials.gov

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