Testing a new prosthesis control method for upper limb amputees
Regulatory Clearance of the Glide Control Strategy for Upper Limb Prostheses
NA · Infinite Biomedical Technologies · NCT06539936
This study is testing a new way to control prosthetic arms to see if it helps people with upper limb amputations perform better and feel more satisfied compared to a standard method.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 7 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Infinite Biomedical Technologies (industry) |
| Locations | 1 site (Redondo Beach, California) |
| Trial ID | NCT06539936 on ClinicalTrials.gov |
What this trial studies
This study compares the Glide prosthesis control strategy with a standard Direct Control (DC) prosthesis in individuals with upper limb amputations. Participants will use both prosthetic systems over a 24-week period, with an initial baseline phase using the DC prosthesis followed by a treatment phase using the Glide prosthesis. The study aims to assess improvements in functional performance, satisfaction, and usage metrics. Participants will be recruited from specialized centers and will receive tailored occupational therapy and prosthetic fitting.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with trans-radial unilateral limb loss who are suitable for a multi-articulated myoelectric hand prosthesis.
Not a fit: Patients with unhealed residual limbs, significant cognitive or neurological deficits, or uncontrolled medical issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to enhanced functionality and satisfaction for upper limb amputees using prosthetic devices.
How similar studies have performed: While the Glide control strategy is a novel approach, similar studies have shown promise in improving prosthetic control and user satisfaction.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Trans-radial unilateral limb loss * Candidate for a multi-articulated myoelectric hand prosthesis as determined by the study prosthetist * Minimal residual limb length for myoelectric control as determined by the clinical team * Age of 18 years or greater Exclusion Criteria: * 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 impacting 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
Redondo Beach, California
- Advanced Arm Dynamics — Redondo Beach, California, United States (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 control, prosthesis, glide