Augmented reality rehabilitation for upper limb amputees
A Patient-Driven Augmented Reality-Based Rehabilitation System to Improve Upper Limb Amputee Outcomes
NA · Infinite Biomedical Technologies · NCT05975970
This study tests if using a special augmented reality system can help people with upper limb amputations control their prosthetic devices better than regular exercises over a month.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Infinite Biomedical Technologies (industry) |
| Locations | 1 site (Edmonton, Alberta) |
| Trial ID | NCT05975970 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of the MyoTrain AR system for individuals with trans-radial upper-limb loss. Participants will be randomly assigned to either a control group using conventional motor imagery exercises or a group training with the MyoTrain AR system over a 30-day period. The study aims to determine if pre-prosthetic training with augmented reality leads to better control stability with prosthetic devices compared to standard care. Functional assessments will be conducted before and after the training period to measure outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with trans-radial unilateral limb loss who are candidates for a myoelectric prosthesis.
Not a fit: Patients with unhealed residual limbs, significant cognitive or neurological deficits, or prior experience with pattern recognition control may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the rehabilitation outcomes for upper limb amputees, leading to improved prosthetic control.
How similar studies have performed: While the use of augmented reality in rehabilitation is a growing field, this specific approach has not been extensively tested, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Trans-radial unilateral limb loss with a healed residual limb * Candidate for a 2+ degree-of-freedom (DoF) myoelectric pattern recognition prosthesis as determined by the study 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
Edmonton, Alberta
- University of Alberta — Edmonton, Alberta, Canada (RECRUITING)
Study contacts
- Study coordinator: Rahul R Kaliki, Ph.D
- 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.
Conditions: Amputation, Upper Limb, amputation, upper limb, myoelectric, training, prosthesis, augmented reality