Long-Term Stability of the Glide Control Strategy

NCT07222085 | Recruiting DMC FDA Device

• 1 other identifier: OR240247
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 10

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

Keywords

Glide; Pattern Recognition; Myoelectric Control; Upper Limb Prostheses

Outcome Measures

Primary Outcomes (2)

• Daily Mean Number of Control Adjustment Sessions (DMNCAS)

  DMNCAS quantifies the number of times a prosthesis user needs to adjust their control strategy to maintain performance. For a PR system, a control adjustment refers to a calibration (or recalibration) of one or more prosthesis movements, while for the Glide control strategy, a control adjustment refers to a change in the Glide map configuration (e.g., electrode gains, slice geometries, assigned movements, etc.). A control adjustment session is then a period of time devoted to performing one or more control adjustments. The number and duration of control adjustment sessions will be recorded in a study diary.

  Weekly, From Prosthesis Delivery (Day 0) to the End of Treatment (Day 168)

• Number of Follow-Up Clinical Interventions (NFCI)

  NFCI reports the number of times the prosthesis user requests the aid of a clinician to resolve an issue with their prescribed control strategy. NFCI refers to clinical interventions (both remote and in-person) that occur post-prosthesis delivery, the number and duration of which will be recorded in a study diary. Diary entries will be verified through a retrospective chart review in collaboration with Medical Center Orthotics \& Prosthetics.

  Weekly, From Prosthesis Delivery (Day 0) to End of Treatment (Day 168)

Secondary Outcomes (6)

• Socket Comfort Score (SCS)

  Weekly, From Prosthesis Delivery (Day 0) to End of Treatment (Day 168)

• Numerical Pain Rating Scale (NPRS)

  Weekly, From Prosthesis Delivery (Day 0) to End of Treatment (Day 168)

• PROMIS Pain Interference - Short Form 4a

  Weekly, From Prosthesis Delivery (Day 0) to End of Treatment (Day 168)

• PROMIS Satisfaction - Short Form 8a

  Weekly, From Prosthesis Delivery (Day 0) to End of Treatment (Day 168)

• OPUS Upper Extremity Functional Scale (UEFS)

  Weekly, From Prosthesis Delivery (Day 0) to End of Treatment (Day 168)

Study Arms (2)

Glide then Pattern Recognition

EXPERIMENTAL

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

Device: Glide Control System; Device: Pattern Recognition System

Pattern Recognition then Glide

EXPERIMENTAL

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

Device: Glide Control System; Device: Pattern Recognition System

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.

Glide then Pattern Recognition; Pattern Recognition then Glide

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.

Glide then Pattern Recognition; Pattern Recognition then Glide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Infinite Biomedical Technologies: lead
• Medical Center Orthotics and Prosthetics: collaborator

Study Sites (10)

Medical Center Orthotics and Prosthetics - Annapolis

Annapolis, Maryland, 21401, United States

RECRUITING

Medical Center Orthotics and Prosthetics - Baltimore

Baltimore, Maryland, 21227, United States

RECRUITING

Medical Center Orthotics and Prosthetics - Silver Spring

Silver Spring, Maryland, 20910, United States

RECRUITING

Medical Center Orthotics and Prosthetics - Allston

Allston, Massachusetts, 02134, United States

RECRUITING

Medical Center Orthotics and Prosthetics - Milton

Milton, Massachusetts, 02186, United States

RECRUITING

Medical Center Orthotics and Prosthetics - Charlotte

Charlotte, North Carolina, 28210, United States

RECRUITING

Medical Center Orthotics and Prosthetics - Anderson

Anderson, South Carolina, 29621, United States

RECRUITING

Medical Center Orthotics and Prosthetics - Greenville

Greenville, South Carolina, 29615, United States

RECRUITING

Medical Center Orthotics and Prosthetics - Fairfax

Fairfax, Virginia, 22031, United States

RECRUITING

Medical Center Orthotics and Prosthetics - Leesburg

Leesburg, Virginia, 20176, United States

RECRUITING

Central Study Contacts

Christopher Hunt, Ph.D

CONTACT

+1 443-451-7175; chris@i-biomed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 27, 2025
• First Posted: October 29, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): April 1, 2029
• Last Updated: November 5, 2025

Record last verified: 2025-11

Locations

US (10)