Long-term stability of the Glide prosthesis control system
Determining the Long-Term Stability of the Glide Control Strategy for Upper Limb Prostheses
NA · Infinite Biomedical Technologies · NCT07222085
This comparison tests whether the Glide control system makes using and managing an advanced myoelectric arm easier for adults with an upper-limb amputation than pattern-recognition control.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Infinite Biomedical Technologies (industry) |
| Locations | 10 sites (Annapolis, Maryland and 9 other locations) |
| Trial ID | NCT07222085 on ClinicalTrials.gov |
What this trial studies
Adults with a healed unilateral trans-radial or trans-humeral amputation who are candidates for a 2+ degree-of-freedom myoelectric prosthesis will be fitted with either the Glide control system or a pattern-recognition control system and followed over time. The study will measure burden of use for both patients and their clinical care teams, device stability, usability, and implications for prosthesis prescription and rehabilitation. People with prior Glide or pattern-recognition experience, unhealed residual limbs, skin sensitivity, or significant cognitive, neurological, or medical problems are excluded. Results are intended to fill gaps in clinically relevant knowledge to guide which control systems clinicians prescribe and how rehabilitation is delivered.
Who should consider this trial
Good fit: Adults 18 or older with a healed unilateral trans-radial or trans-humeral amputation who are candidates for a 2+ DOF myoelectric prosthesis and have no prior Glide or pattern-recognition experience.
Not a fit: People with unhealed residual limbs, easily damaged or sensitive skin, significant cognitive/neurological/physical deficits, uncontrolled pain, serious uncontrolled medical problems, or prior Glide/PR experience are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, this could make advanced myoelectric prostheses easier to use and reduce clinical workload, improving long-term use and patient satisfaction.
How similar studies have performed: Pattern-recognition myoelectric control has shown promise in laboratory and short-term clinical work, but long-term real-world benefits have been mixed and long-term data on Glide control are limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Annapolis, Maryland and 9 other locations
- Medical Center Orthotics and Prosthetics - Annapolis — Annapolis, Maryland, United States (RECRUITING)
- Medical Center Orthotics and Prosthetics - Baltimore — Baltimore, Maryland, United States (RECRUITING)
- Medical Center Orthotics and Prosthetics - Silver Spring — Silver Spring, Maryland, United States (RECRUITING)
- Medical Center Orthotics and Prosthetics - Allston — Allston, Massachusetts, United States (RECRUITING)
- Medical Center Orthotics and Prosthetics - Milton — Milton, Massachusetts, United States (RECRUITING)
- Medical Center Orthotics and Prosthetics - Charlotte — Charlotte, North Carolina, United States (RECRUITING)
- Medical Center Orthotics and Prosthetics - Anderson — Anderson, South Carolina, United States (RECRUITING)
- Medical Center Orthotics and Prosthetics - Greenville — Greenville, South Carolina, United States (RECRUITING)
- Medical Center Orthotics and Prosthetics - Fairfax — Fairfax, Virginia, United States (RECRUITING)
- Medical Center Orthotics and Prosthetics - Leesburg — Leesburg, Virginia, United States (RECRUITING)
Study contacts
- Study coordinator: Christopher Hunt, Ph.D
- Email: chris@i-biomed.com
- Phone: +1 443-451-7175
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Upper Limb Amputation Above Elbow, Upper Limb Amputation Below Elbow, Glide, Pattern Recognition, Myoelectric Control, Upper Limb Prostheses