Evaluating the MyoTrain System for Individuals with Trans-radial Limb Loss
Regulatory Clearance of a Rehabilitation System for Individuals With Upper Limb Loss
This study is testing if the MyoTrain system can help people who have lost their arm below the elbow learn to use prosthetics better compared to regular training methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Infinite Biomedical Technologies Industry-sponsored |
| Locations | 1 site (Grand Rapids, Michigan) |
| Trial ID | NCT05888428 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the efficacy of the MyoTrain system in individuals who have experienced trans-radial upper-limb loss. Sixteen participants will be randomly assigned to either a control group using standard motor imagery training or a group utilizing the MyoTrain system over a 206-day period. The study will evaluate the transfer of skills to prosthetic control, the correlation of virtual outcome measures with real-world functional outcomes, and improvements in clinical outcomes through various metrics. Participants will undergo a pre-prosthetic training period before receiving their prosthetic devices and occupational therapy.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with unilateral trans-radial limb loss who are suitable for a myoelectric prosthesis.
Not a fit: Patients with prior experience using pattern recognition control or those with unhealed wounds or significant cognitive, neurological, or physical deficits may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the functional capabilities of individuals with trans-radial limb loss through improved prosthetic control.
How similar studies have performed: While the MyoTrain system is a novel approach, similar studies have shown promise in improving prosthetic control through advanced training techniques.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Trans-radial unilateral limb loss * Candidate for a 2+ degree-of-freedom myoelectric pattern recognition prosthesis as determined by prosthetist * Fluent in English * Age of 18 years or greater Exclusion Criteria: * Prior experience with pattern recognition control * Patients with a residual limb that is unhealed from the amputation surgery * Patients with easily damaged or sensitive skin who would not tolerate EMG electrodes * Unhealed wounds * 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 impactive full participation in the study as determined upon clinical evaluation * Serious uncontrolled medical problems as judged by the project therapist
Where this trial is running
Grand Rapids, Michigan
- Hanger Clinic - Grand Rapids — Grand Rapids, Michigan, United States (Recruiting)
Study contacts
- Study coordinator: Rahul R Kaliki
- Email: rahul@i-biomed.com
- Phone: 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.