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

Summary

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

Interventions

DEVICE

MyoTrain

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.

BEHAVIORAL

Motor Imagery

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.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS)

  collaborator NIH

• Johns Hopkins University

  collaborator OTHER

• Hanger Clinic: Prosthetics & Orthotics

  collaborator OTHER

• Infinite Biomedical Technologies

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-02-02

Primary Completion

2026-08-31

Completion

2026-08-31

FDA Device

Yes

Countries

• United States

Study Locations