RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-02-02
Study Completion:2026-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05888428

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Trans-radial unilateral limb loss
  2. * Candidate for a 2+ degree-of-freedom myoelectric pattern recognition prosthesis as determined by prosthetist
  3. * Fluent in English
  4. * Age of 18 years or greater
  1. * Prior experience with pattern recognition control
  2. * Patients with a residual limb that is unhealed from the amputation surgery
  3. * Patients with easily damaged or sensitive skin who would not tolerate EMG electrodes
  4. * Unhealed wounds
  5. * Significant cognitive deficits as determined upon clinical evaluation
  6. * Significant neurological deficits as determined upon clinical evaluation
  7. * Significant physical deficits of the residual limb impacting full participation in the study as determined upon clinical evaluation
  8. * Uncontrolled pain or phantom pain impactive full participation in the study as determined upon clinical evaluation
  9. * Serious uncontrolled medical problems as judged by the project therapist

Contacts and Locations

Study Contact

Rahul R Kaliki
CONTACT
443-451-7175
rahul@i-biomed.com

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Infinite Biomedical Technologies

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-02
Study Completion Date2026-01-31

Study Record Updates

Study Start Date2024-02-02
Study Completion Date2026-01-31

Terms related to this study

Keywords Provided by Researchers

  • amputation
  • upper limb
  • myoelectric
  • training
  • prosthesis

Additional Relevant MeSH Terms

  • Amputation
  • Upper Limb