MyoTrain for Upper Extremity Amputation
Trial Summary
What is the purpose of this trial?
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.
Do I need to stop my current medications for the MyoTrain trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment MyoTrain for Upper Extremity Amputation?
Research shows that virtual reality training platforms can effectively teach people with upper limb loss to control advanced prosthetic limbs, improving their ability to perform complex motions. This suggests that MyoTrain, which uses a virtual-limb training system, may help individuals learn to use their prostheses more effectively.12345
Is MyoTrain safe for human use?
How is the MyoTrain treatment different from other treatments for upper extremity amputation?
MyoTrain is unique because it uses a virtual reality system to train individuals with upper extremity amputations to control advanced prosthetic limbs, allowing them to practice muscle movements and control schemes in a simulated environment before receiving their prosthesis. This approach is more engaging and can be done at home, making it different from traditional training methods that often require in-person sessions with a therapist.19101112
Eligibility Criteria
This trial is for adults over 18 who have lost a limb at the forearm level, are fluent in English, and qualify for an advanced myoelectric prosthesis. It's not suitable for those with other types of limb loss or conditions that would exclude them from using this technology.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants undergo a baseline functional assessment before starting the training period
Pre-prosthetic Training
Participants undergo a 30-day pre-prosthetic training period specific to their assigned group
Prosthetic Device Delivery and Occupational Therapy
Participants receive their prosthetic device and occupational therapy consistent with the current clinical care standard
At-home Prosthesis Use
Participants complete 3 blocks of 56-day at-home prosthesis use, with clinic assessments in between
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- MyoTrain
MyoTrain is already approved in United States for the following indications:
- Pre-prosthetic training for individuals with upper limb loss
Find a Clinic Near You
Who Is Running the Clinical Trial?
Infinite Biomedical Technologies
Lead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Johns Hopkins University
Collaborator
Hanger Clinic: Prosthetics & Orthotics
Collaborator