Study of Efficacy of the MyoTrain System in a Population of Individuals With Trans-radial Limb Loss (NCT05888428)
Regulatory Clearance of a Rehabilitation System for Individuals With Upper Limb Loss
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Hanger Clinic - Grand Rapids โ Grand Rapids, Michigan
Age range: 18 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (1 Sites)
- Hanger Clinic - Grand Rapids โ Grand Rapids, Michigan
๐ Contact the Study Coordinator
Phone: (443) 451-7175
Email: rahul@i-biomed.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- Magnetic Bead Tracking System and eOPRA Implant System With Bionic Prosthesis for Transtibial Amputees โ Boston, Massachusetts
- Personalized Mobility Interventions Using Smart Sensor Resources for Lower-Limb Prosthesis Users โ Chicago, Illinois
- Optimizing Prosthetic Prescription to Mitigate the Effects of Perspiration โ Seattle, Washington
Explore by condition: All Amputation clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.