Actively Recruiting
Regulatory Clearance of the Glide Control Strategy for Upper Limb Prostheses
Led by Infinite Biomedical Technologies · Updated on 2025-03-24
7
Participants Needed
1
Research Sites
80 weeks
Total Duration
On this page
Sponsors
I
Infinite Biomedical Technologies
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Regulatory Clearance of the Glide Control Strategy for Upper Limb Prostheses
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Unilateral trans-radial limb loss
- Candidate for a multi-articulated myoelectric hand prosthesis as determined by the study prosthetist
- Minimal residual limb length suitable for myoelectric control as determined by the clinical team
- Age 18 years or older
You will not qualify if you...
- Unhealed residual limb from amputation surgery
- Easily damaged or sensitive skin that cannot tolerate EMG electrodes
- Unhealed wounds
- Significant cognitive deficits as determined by clinical evaluation
- Significant neurological deficits as determined by clinical evaluation
- Significant physical deficits of the residual limb impacting full study participation
- Uncontrolled pain or phantom pain impacting study participation
- Serious uncontrolled medical problems as judged by the project therapist
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Advanced Arm Dynamics
Redondo Beach, California, United States, 90277
Actively Recruiting
Research Team
R
Rahul R Kaliki, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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