NCT06539936 Regulatory Clearance of the Glide Control Strategy for Upper Limb Prostheses
| NCT ID | NCT06539936 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Infinite Biomedical Technologies |
| Condition | Amputation |
| Study Type | INTERVENTIONAL |
| Enrollment | 7 participants |
| Start Date | 2024-09-16 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 7 participants in total. It began in 2024-09-16 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The investigators will test the following hypothesis: Use of Glide results in improved functional performance, satisfaction, and usage metrics as compared to use of a standard Direct Control (DC) prosthesis. This study will compare the use of Glide \[Experimental\] prosthesis with a DC \[Standard\] prosthesis in a clinical setting and in unsupervised daily activity. We will follow a multiple baseline design, specifically an AB design. Each of the subjects will use the Experimental and Standard systems over a total of 24-weeks. The A phase is the baseline phase where the DC prosthesis will be used, and the B phase will be the treatment phase where the Glide prosthesis will be used. Participants will undergo an A phase of either 10-weeks, 12-weeks, or 14-weeks duration, with the remaining 14-, 12-, or 10-weeks of the study being dedicated to the B phase.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06539936 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Amputation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06539936 currently recruiting?
Yes, NCT06539936 is actively recruiting participants. Contact the research team at rahul@i-biomed.com for enrollment information.
Where is the NCT06539936 trial being conducted?
This trial is being conducted at Redondo Beach, United States.
Who is sponsoring the NCT06539936 clinical trial?
NCT06539936 is sponsored by Infinite Biomedical Technologies. The trial plans to enroll 7 participants.