Regulatory Clearance of the Glide Control Strategy for Upper Limb Prostheses
Infinite Biomedical Technologies · with Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Advanced Arm Dynamics · NCT06539936
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Not applicable
- Target enrollment
- 7
- US sites recruiting
- 1
- Study start
- September 16, 2024
- Record last updated
- May 29, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study 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.
Being studied: Glide; Direct Control
Conditions: Amputation; Upper Limb
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
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
Recruiting US locations
Advanced Arm Dynamics
Redondo Beach, CA 90277
Site contact: John M Miguelez, CP, FAAOP (D) · (310) 372-3050 · jmiguelez@armdynamics.com
Study contacts (from the official record)
- Rahul R Kaliki, Ph.D · (443) 451-7175 · rahul@i-biomed.com