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 — DEVICE
    Glide 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 — DEVICE
    Pattern 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 Recognition
    Participants use a Glide-controlled upper limb prosthesis first, followed by a Pattern Recognition-based upper limb prosthesis.
  • Experimental: Pattern Recognition then Glide
    Participants 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

Locations (10)

FacilityCityStateZIPSite coordinators
Medical Center Orthotics and Prosthetics - AnnapolisAnnapolisMaryland21401
James Vandersea, CPO
+1 (410) 573-2374
Medical Center Orthotics and Prosthetics - BaltimoreBaltimoreMaryland21227
James Vandersea, CPO
+1 (410) 800-4730
Medical Center Orthotics and Prosthetics - Silver SpringSilver SpringMaryland20910
James Vandersea, CPO
+1 (301) 585-5347
Medical Center Orthotics and Prosthetics - AllstonAllstonMassachusetts02134
James Vandersea, CPO
+1 (617) 208-8468
Medical Center Orthotics and Prosthetics - MiltonMiltonMassachusetts02186
James Vandersea, CPO
+1 (617) 698-6334
Medical Center Orthotics and Prosthetics - CharlotteCharlotteNorth Carolina28210
James Vandersea, CPO
+1 (704) 644-3636
Medical Center Orthotics and Prosthetics - AndersonAndersonSouth Carolina29621
James Vandersea, CPO
+1 (864) 225-1683
Medical Center Orthotics and Prosthetics - GreenvilleGreenvilleSouth Carolina29615
James Vandersea, CPO
+1 (864) 676-0029
Medical Center Orthotics and Prosthetics - FairfaxFairfaxVirginia22031
James Vandersea, CPO
+1 (703) 698-5007
Medical Center Orthotics and Prosthetics - LeesburgLeesburgVirginia20176
James Vandersea, CPO
+1 (571) 291-3121

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