Regulatory Clearance of the Glide Control Strategy for Upper Limb Prostheses

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.

NCT Number	NCT06539936
Lead Sponsor	Infinite Biomedical Technologies Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Advanced Arm Dynamics
Conditions	Amputation, Upper Limb
Enrollment	7 participants
Start Date	2024-09-16
Primary Completion	2027-03-31 (estimated)
Study Completion	2027-03-31 (estimated)
Updated on ClinicalTrials.gov	2026-05-29