Study of Efficacy of the MyoTrain System in a Population of Individuals With Trans-radial Limb Loss
Infinite Biomedical Technologies · with National Institute of Neurological Disorders and Stroke (NINDS), Johns Hopkins University · NCT05888428
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Not applicable
- Target enrollment
- 16
- US sites recruiting
- 1
- Study start
- February 2, 2024
- Record last updated
- October 29, 2025
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study 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:
- The use of MyoTrain results in skills transference to control of the final prosthesis
- The virtual outcome measures in MyoTrain are correlated with real-world functional outcome measures
- 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.
Being studied: MyoTrain; Motor Imagery
Conditions: Amputation; Upper Limb
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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
Recruiting US locations
Hanger Clinic - Grand Rapids
Grand Rapids, MI 49546
Site contact: Ryan Sheridan, CPO, FAAOP · (616) 940-0878 · rsheridan@hanger.com
Study contacts (from the official record)
- Rahul R Kaliki · 443-451-7175 · rahul@i-biomed.com