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

Infinite Biomedical Technologies

Status: Enrolling

Conditions: Upper Limb; Amputation

Treatments: Device: MyoTrain AR; Behavioral: Motor Imagery

Study type: Interventional

Funder types: Other; Industry; Other U.S. Federal agency

Identifiers

NCT05975970

W81XWH2010919

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Trans-radial unilateral limb loss with a healed residual limb
• Candidate for a 2+ degree-of-freedom (DoF) myoelectric pattern recognition prosthesis as determined by the study prosthetist
• Fluent in English
• Age of 18 years or greater

Exclusion criteria

• Prior experience with pattern recognition control
• Patients with a residual limb that is unhealed from the amputation surgery
• Patients with easily damaged or sensitive skin who would not tolerate EMG electrodes
• Unhealed wounds
• Significant cognitive deficits as determined upon clinical evaluation
• Significant neurological deficits as determined upon clinical evaluation
• Significant physical deficits of the residual limb impacting full participation in the study as determined upon clinical evaluation
• Uncontrolled pain or phantom pain impactive full participation in the study as determined upon clinical evaluation
• Serious uncontrolled medical problems as judged by the project therapist

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

MyoTrain AR System

Experimental group

Description:

Participants will undergo functional task training using the MyoTrain AR system, which includes the HoloLens 2 augmented reality head-mounted display, four HTC VIVE SteamVR kinematic trackers, eight surface EMG electrodes based on the Element hardware platform, and a desktop computer. Participants will be prompted to use a pattern recognition-based myoelectric controller to operate a virtual prosthesis and complete a simulation of the GaMA Cup Transfer Task.

Treatment:

Device: MyoTrain AR

Conventional Motor Imagery

Active Comparator group

Description:

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 or functional assessment.

Treatment:

Behavioral: Motor Imagery