Long-Term Stability of the Glide Control Strategy
Part of paid clinical trials in Annapolis, Maryland.
- Sponsor
- Infinite Biomedical Technologies
- Study ID
- NCT07222085
- Status
- Recruiting
Conditions
- Upper Limb Amputation Above Elbow
- Upper Limb Amputation Below Elbow
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Glide Control System — DEVICEGlide is a commercially developed directional myoelectric control strategy from Infinite Biomedical Technologies (IBT) that sits between classic Direct Control (DC) and modern Pattern Recognition (PR). Instead of requiring an isolated on/off muscle signal for each function (e.g., DC) or training a complex classifier on many gestures (e.g., PR), Glide uses the relative activity across 2-8 EMG electrodes to move a virtual cursor on a 2-D "Glide map." The map is divided into adjustable sectors ("slices"), and each slice is assigned a prosthetic movement (e.g., hand open/close, wrist rotation, elbow flexion). Moving the cursor into a slice actuates that movement.
- Pattern Recognition System — DEVICEPattern recognition (PR)-based myoelectric control is a data-driven approach that allows a user to control multiple prosthetic functions using natural muscle activation patterns rather than discrete, isolated signals. Instead of mapping one muscle to one motion (as in conventional Direct Control), PR systems record the spatial and temporal pattern of EMG activity from multiple sites on the residual limb and use machine learning algorithms to classify which intended movement the user is trying to make.
Study Details
This research is intended to test whether the prescription of the Glide prosthesis control system reduces the burden of use for both patients and their clinical care team as compared to use of Pattern Recognition-based advanced myoelectric control. The goal of the study is to fill the gaps in clinically relevant knowledge to inform the prescription of prosthesis components and the rehabilitation process.
Key Dates
- Start date
- Oct 15, 2025
- Status verified
- Nov 2025
- Primary completion
- Nov 30, 2028
- Completion
- Apr 30, 2029
Study Design
- Enrollment
- 12 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- TREATMENT
Arms
- Experimental: Glide then Pattern RecognitionParticipants use a Glide-controlled upper limb prosthesis first, followed by a Pattern Recognition-based upper limb prosthesis.
- Experimental: Pattern Recognition then GlideParticipants use a Pattern Recognition-based upper limb prosthesis first, followed by a Glide-controlled upper limb prosthesis.
Primary Outcome Measure
Daily Mean Number of Control Adjustment Sessions (DMNCAS) [ Time Frame: Weekly, From Prosthesis Delivery (Day 0) to the End of Treatment (Day 168) ]
Central Contacts
- Christopher Hunt, Ph.D+1 443-451-7175
Locations (10)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Medical Center Orthotics and Prosthetics - Annapolis | Annapolis | Maryland | 21401 | |
| Medical Center Orthotics and Prosthetics - Baltimore | Baltimore | Maryland | 21227 | |
| Medical Center Orthotics and Prosthetics - Silver Spring | Silver Spring | Maryland | 20910 | |
| Medical Center Orthotics and Prosthetics - Allston | Allston | Massachusetts | 02134 | |
| Medical Center Orthotics and Prosthetics - Milton | Milton | Massachusetts | 02186 | |
| Medical Center Orthotics and Prosthetics - Charlotte | Charlotte | North Carolina | 28210 | |
| Medical Center Orthotics and Prosthetics - Anderson | Anderson | South Carolina | 29621 | |
| Medical Center Orthotics and Prosthetics - Greenville | Greenville | South Carolina | 29615 | |
| Medical Center Orthotics and Prosthetics - Fairfax | Fairfax | Virginia | 22031 | |
| Medical Center Orthotics and Prosthetics - Leesburg | Leesburg | Virginia | 20176 |
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Medical Center Orthotics and Prosthetics - Annapolis· Annapolis, MDMedical Center Orthotics and Prosthetics - Baltimore· Baltimore, MDMedical Center Orthotics and Prosthetics - Silver Spring· Silver Spring, MDMedical Center Orthotics and Prosthetics - Allston· Allston, MAMedical Center Orthotics and Prosthetics - Milton· Milton, MAMedical Center Orthotics and Prosthetics - Charlotte· Charlotte, NC