NCT05975970

A Patient-Driven Augmented Reality-Based Rehabilitation System to Improve Upper Limb Amputee Outcomes

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Infinite Biomedical Technologies · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators propose to evaluate the efficacy of MyoTrain AR in a prospective clinical study involving 10 individuals with trans-radial upper-limb loss over a period of 35 days. These individuals will be randomized to Group A (Control Group using conventional motor imagery exercises) and Group B (who will train with the MyoTrain AR system pre-prosthetically). The investigators will test the following hypothesis: Pre-prosthetic training with the MyoTrain AR system, as compared to the current standard of care with conventional motor imagery exercises, results in improved subsequent control stability with the prosthesis. 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 repeat the functional assessment. Participants will then receive their prosthetic device and occupational therapy consistent with the current clinical care standard, after which they will again undergo a battery of validated, clinical assessments.

Conditions

• Amputation
• Upper Limb

Interventions

Type	Name	Description
DEVICE	MyoTrain AR	MyoTrain AR is a virtual prosthesis functional training system. From a hardware perspective it consists of an augmented reality head-mounted display (HMD), four SteamVR kinematic trackers, eight surface EMG electrodes based on the Element electrode platform, and a desktop computer to facilitate wireless communication between the various hardware components. From a software perspective, MyoTrain AR was developed in the cross-platform Unity 4.0 game development engine.
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.

Timeline

• Start date: 2023-10-02
• Primary completion: 2024-09-01
• Completion: 2024-09-01
• First posted: 2023-08-04
• Last updated: 2024-01-10

Locations

1 site across 1 country: Canada