Actively Recruiting
Study of Efficacy of the MyoTrain System in a Population of Individuals With Trans-radial Limb Loss
Led by Infinite Biomedical Technologies · Updated on 2025-10-29
16
Participants Needed
1
Research Sites
134 weeks
Total Duration
On this page
Sponsors
I
Infinite Biomedical Technologies
Lead Sponsor
N
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of Efficacy of the MyoTrain System in a Population of Individuals With Trans-radial Limb Loss
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Prior experience with pattern recognition control
- Residual limb unhealed from amputation surgery
- Easily damaged or sensitive skin intolerant to EMG electrodes
- Unhealed wounds
- Significant cognitive deficits as determined by clinical evaluation
- Significant neurological deficits as determined by clinical evaluation
- Significant physical deficits of the residual limb impacting study participation
- Uncontrolled pain or phantom pain impacting study participation
- Serious uncontrolled medical problems judged by the project therapist
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hanger Clinic - Grand Rapids
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
Research Team
R
Rahul R Kaliki
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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