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Recruiting NCT07222085

Long-Term Stability of the Glide Control Strategy

No phase Interventional Upper Limb Amputation Above Elbow Upper Limb Amputation Below Elbow

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Glide Control System, Pattern Recognition System.
Who it may be relevant to
Registry conditions: Upper Limb Amputation Above Elbow, Upper Limb Amputation Below Elbow. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Determining the Long-Term Stability of the Glide Control Strategy for Upper Limb Prostheses

Overview

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.

Interventions

  • Device 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 ("sl
  • 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

Primary outcome measures

  • 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)]
Secondary outcome measures (6)
  • Socket Comfort Score (SCS) [Time frame: Weekly, From Prosthesis Delivery (Day 0) to End of Treatment (Day 168)]
  • Numerical Pain Rating Scale (NPRS) [Time frame: Weekly, From Prosthesis Delivery (Day 0) to End of Treatment (Day 168)]
  • PROMIS Pain Interference - Short Form 4a [Time frame: Weekly, From Prosthesis Delivery (Day 0) to End of Treatment (Day 168)]
  • PROMIS Satisfaction - Short Form 8a [Time frame: Weekly, From Prosthesis Delivery (Day 0) to End of Treatment (Day 168)]
  • OPUS Upper Extremity Functional Scale (UEFS) [Time frame: Weekly, From Prosthesis Delivery (Day 0) to End of Treatment (Day 168)]
  • Mean Daily Prosthesis Wear Duration (MDPWD) [Time frame: Weekly, From Prosthesis Delivery (Day 0) to End of Treatment (Day 168)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 10 centers
  • Medical Center Orthotics and Prosthetics - Annapolis — Annapolis
  • Medical Center Orthotics and Prosthetics - Baltimore — Baltimore
  • Medical Center Orthotics and Prosthetics - Silver Spring — Silver Spring
  • Medical Center Orthotics and Prosthetics - Allston — Allston
  • Medical Center Orthotics and Prosthetics - Milton — Milton
  • Medical Center Orthotics and Prosthetics - Charlotte — Charlotte
  • Medical Center Orthotics and Prosthetics - Anderson — Anderson
  • Medical Center Orthotics and Prosthetics - Greenville — Greenville
  • … and 2 more centers

Identifiers

NCT: NCT07222085 · OR240247

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗