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Regulatory Clearance of the Glide Control Strategy for Upper Limb Prostheses

Who can join

Ages 18 and older · All sexes

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

About the study

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.

What is being tested

• Glide (device)
• Direct Control (device)

Sponsor: Infinite Biomedical Technologies · Participants: 7 · Started: Sep 16, 2024

Contact the study team

• Rahul R Kaliki, Ph.D · Phone: (443) 451-7175

Official record on ClinicalTrials.gov — NCT06539936

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.