Long-Term Stability of the Glide Control Strategy

NCT ID: NCT07222085

Last Updated: 2025-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-15

Study Completion Date

2029-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Upper Limb Amputation Above Elbow Upper Limb Amputation Below Elbow

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

The study participants will then be randomly block assigned to one of two groups in pair: Group AB will be prescribed a commercial Pattern Recognition (PR) system for the first Phase of the take-home evaluation and Glide for the second Phase. Group BA will be prescribed the control strategies in the inverse order, using Glide during the first Phase and a commercial PR system during the second. Within each group, participants will be again randomly assigned into one of three subgroups: AB10, AB12, and AB14 (or BA10, BA12, and BA14). These subgroups determine the duration of the first (i.e., baseline) Phase, with subgroups correlating to 10-weeks, 12-weeks, and 14-weeks.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Glide then Pattern Recognition

Participants use a Glide-controlled upper limb prosthesis first, followed by a Pattern Recognition-based upper limb prosthesis.

Group Type EXPERIMENTAL

Glide Control System

Intervention Type 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

Intervention Type 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.

Pattern Recognition then Glide

Participants use a Pattern Recognition-based upper limb prosthesis first, followed by a Glide-controlled upper limb prosthesis.

Group Type EXPERIMENTAL

Glide Control System

Intervention Type 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

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medical Center Orthotics and Prosthetics

UNKNOWN

Sponsor Role collaborator

Infinite Biomedical Technologies

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medical Center Orthotics and Prosthetics - Annapolis

Annapolis, Maryland, United States

Site Status RECRUITING

Medical Center Orthotics and Prosthetics - Baltimore

Baltimore, Maryland, United States

Site Status RECRUITING

Medical Center Orthotics and Prosthetics - Silver Spring

Silver Spring, Maryland, United States

Site Status RECRUITING

Medical Center Orthotics and Prosthetics - Allston

Allston, Massachusetts, United States

Site Status RECRUITING

Medical Center Orthotics and Prosthetics - Milton

Milton, Massachusetts, United States

Site Status RECRUITING

Medical Center Orthotics and Prosthetics - Charlotte

Charlotte, North Carolina, United States

Site Status RECRUITING

Medical Center Orthotics and Prosthetics - Anderson

Anderson, South Carolina, United States

Site Status RECRUITING

Medical Center Orthotics and Prosthetics - Greenville

Greenville, South Carolina, United States

Site Status RECRUITING

Medical Center Orthotics and Prosthetics - Fairfax

Fairfax, Virginia, United States

Site Status RECRUITING

Medical Center Orthotics and Prosthetics - Leesburg

Leesburg, Virginia, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Christopher Hunt, Ph.D

Role: CONTACT

+1 443-451-7175

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

James Vandersea, CPO

Role: primary

+1 (410) 573-2374

James Vandersea, CPO

Role: primary

+1 (410) 800-4730

James Vandersea, CPO

Role: primary

+1 (301) 585-5347

James Vandersea, CPO

Role: primary

+1 (617) 208-8468

James Vandersea, CPO

Role: primary

+1 (617) 698-6334

James Vandersea, CPO

Role: primary

+1 (704) 644-3636

James Vandersea, CPO

Role: primary

+1 (864) 225-1683

James Vandersea, CPO

Role: primary

+1 (864) 676-0029

James Vandersea, CPO

Role: primary

+1 (703) 698-5007

James Vandersea, CPO

Role: primary

+1 (571) 291-3121

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

OR240247

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Neuromusculoskeletal Interface for Bionic Arms
NCT07032753 NOT_YET_RECRUITING NA
Active Knee Prosthesis Study
NCT06700668 ACTIVE_NOT_RECRUITING NA