Status:
RECRUITING
Regulatory Clearance of the Glide Control Strategy for Upper Limb Prostheses
Lead Sponsor:
Infinite Biomedical Technologies
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Advanced Arm Dynamics
Conditions:
Amputation
Upper Limb
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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) pros...
Detailed Description
Recruitment and group assignment: Participants will be recruited through one of Arm Dynamics's six Centers of Excellence. Potentially eligible participants will be identified by their care team and re...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT06539936
Start Date
September 16 2024
End Date
March 31 2026
Last Update
March 24 2025
Active Locations (1)
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1
Advanced Arm Dynamics
Redondo Beach, California, United States, 90277