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Study of Efficacy of the MyoTrain System in a Population of Individuals With Trans-radial Limb Loss

Regulatory Clearance of a Rehabilitation System for Individuals With Upper Limb Loss

Who can join

Ages 18 and older · All sexes

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

About the study

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.

What is being tested

• MyoTrain (device)
• Motor Imagery (behavioral)

Sponsor: Infinite Biomedical Technologies · Participants: 16 · Started: Feb 2, 2024

Contact the study team

• Rahul R Kaliki · Phone: 443-451-7175

Official record on ClinicalTrials.gov — NCT05888428

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.