Recruiting

Glide Prosthesis

Sponsor:

Infinite Biomedical Technologies

Code:

NCT07222085

Conditions

Upper Limb Amputation Above Elbow

Upper Limb Amputation Below Elbow

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Glide Control System

Pattern Recognition System

Study Details

Brief summary:

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.

Conditions

Upper Limb Amputation Above Elbow

Upper Limb Amputation Below Elbow

Study ID

NCT07222085

Start date

Oct 15, 2025

Status verified date

Nov, 2025

Completion date

Apr, 2029

Anticipated

Primary completion date

Nov, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Unilateral trans-radial or trans-humeral limb loss with a healed residual limb
  • Candidate for 2+ degree-of-freedom (DOF) myoelectric prosthesis as determined by the study prosthetist
  • Age of 18 years or greater

Exclusion Criteria:

  • Prior experience with Pattern Recognition or Glide control
  • Individuals with a residual limb that is unhealed from the amputation surgery
  • Individuals with easily damaged or sensitive skin who would not tolerate EMG electrodes
  • 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

Study Design

Enrollment

12 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Glide Control System

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

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.

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) ]
  • Number of Follow-Up Clinical Interventions (NFCI) [ Time Frame: Weekly, From Prosthesis Delivery (Day 0) to End of Treatment (Day 168) ]

Central Contacts and Locations

Central contacts

Locations

Medical Center Orthotics and Prosthetics - Annapolis

Recruiting

Annapolis, Maryland, United States, 21401

Contacts

Medical Center Orthotics and Prosthetics - Baltimore

Recruiting

Baltimore, Maryland, United States, 21227

Contacts

Medical Center Orthotics and Prosthetics - Silver Spring

Recruiting

Silver Spring, Maryland, United States, 20910

Contacts

Medical Center Orthotics and Prosthetics - Allston

Recruiting

Allston, Massachusetts, United States, 02134

Contacts

Medical Center Orthotics and Prosthetics - Milton

Recruiting

Milton, Massachusetts, United States, 02186

Contacts

Medical Center Orthotics and Prosthetics - Charlotte

Recruiting

Charlotte, North Carolina, United States, 28210

Contacts

Medical Center Orthotics and Prosthetics - Anderson

Recruiting

Anderson, South Carolina, United States, 29621

Contacts

Medical Center Orthotics and Prosthetics - Greenville

Recruiting

Greenville, South Carolina, United States, 29615

Contacts

Medical Center Orthotics and Prosthetics - Fairfax

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Medical Center Orthotics and Prosthetics - Leesburg

Recruiting

Leesburg, Virginia, United States, 20176

Contacts

More Information

Sponsor

Infinite Biomedical Technologies

Last update posted

Nov 5, 2025

Last verified

Nov, 2025

Keywords

  • Glide
  • Pattern Recognition
  • Myoelectric Control
  • Upper Limb Prostheses

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Infinite Biomedical Technologies on 2025-11-05.