NCT05888428 Study of Efficacy of the MyoTrain System in a Population of Individuals With Trans-radial Limb Loss
| NCT ID | NCT05888428 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Infinite Biomedical Technologies |
| Condition | Amputation |
| Study Type | INTERVENTIONAL |
| Enrollment | 16 participants |
| Start Date | 2024-02-02 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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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 16 participants in total. It began in 2024-02-02 with a primary completion date of 2026-08-31.
⚠ 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 propose to evaluate the efficacy of MyoTrain in a prospective clinical study involving 16 individuals with trans-radial upper-limb loss over a period of 206 days. These individuals will be randomized to Group A (Control Group using standard motor imagery training) and Group B (who are provided the MyoTrain system). The investigators will test three hypotheses: 1. The use of MyoTrain results in skills transference to control of the final prosthesis 2. The virtual outcome measures in MyoTrain are correlated with real-world functional outcome measures 3. The use of MyoTrain results in improved clinical outcomes as measured by functional, subjective and usage metrics Following a baseline functional assessment, participants will undergo a 30-day pre-prosthetic training period specific to their assigned Group. After this training period, participants will receive their prosthetic device and occupational therapy consistent with the current clinical care standard, after which they will again undergo clinical assessment. Post-device delivery, participants will then complete 3 56-day blocks of at-home prosthesis use, in between which they will return to clinic for assessment.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05888428 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 NCT05888428 currently recruiting?
Yes, NCT05888428 is actively recruiting participants. Contact the research team at rahul@i-biomed.com for enrollment information.
Where is the NCT05888428 trial being conducted?
This trial is being conducted at Grand Rapids, United States.
Who is sponsoring the NCT05888428 clinical trial?
NCT05888428 is sponsored by Infinite Biomedical Technologies. The trial plans to enroll 16 participants.