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

Part of paid clinical trials in Grand Rapids, Michigan.

Sponsor
Infinite Biomedical Technologies
Study ID
NCT05888428
Status
Recruiting
Apply to this trial

Conditions

  • Amputation
  • Upper Limb

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MyoTrain — DEVICE
    MyoTrain is a virtual prosthesis control training system. From a hardware perspective it consists of an Apple iPad tablet computer and an eight-channel EMG armband, based on the Element electrode platform, which interfaces with the tablet via Bluetooth™. From a software perspective, MyoTrain was developed in the cross-platform Unity 4.0 game development environment.
  • Motor Imagery — BEHAVIORAL
    Motor imagery describes the process by which a prosthesis user mentally simulates the execution of a desired limb movement and activates the musculature of the residual limb that would generate the desired movement.

Study Details

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.

Key Dates

Start date
Feb 2, 2024
Status verified
Oct 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
16 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Experimental
    Participants will be provided with the take-home MyoTrain system, which includes the MyoTrain armband, iPad, and MyoTrain software. Participants will progress through the training modules of the MyoTrain software, starting with eliciting paired single DoF antagonistic movements and ending with the proportional control of complex, 2-DoF hand and wrist movements.
  • Active Comparator: Control
    Participants will be provided motor imagery exercises that involve brief attempts to move the missing limb in a similar manner to how they would control their pattern recognition system to strengthen their muscles. These exercises do not involve any real-time control feedback.

Primary Outcome Measure

Mean Prosthesis Wear Duration [ Time Frame: Days 35-206 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hanger Clinic - Grand RapidsGrand RapidsMichigan49546
Ryan Sheridan, CPO, FAAOP
[email protected]
(616) 940-0878

Find similar trials in Grand Rapids, MI

By research site
Hanger Clinic - Grand Rapids· Grand Rapids, MI

Related Studies