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

Description

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

Amputation, Upper Limb

Study Overview

Study Details

Study overview

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.

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

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

Condition
Amputation
Intervention / Treatment

-

Contacts and Locations

Grand Rapids

Hanger Clinic - Grand Rapids, Grand Rapids, Michigan, United States, 49546

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Infinite Biomedical Technologies,

Study Record Dates

2026-01-31