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

NCT ID: NCT05975970

Last Updated: 2024-01-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-02
• Study Completion Date: 2024-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

MyoTrain AR System

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.

Group Type: EXPERIMENTAL

MyoTrain AR

Intervention Type: DEVICE

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.

Conventional Motor Imagery

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.

Group Type: ACTIVE_COMPARATOR

Motor Imagery

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

University of Alberta

OTHER

Sponsor Role: collaborator

Infinite Biomedical Technologies

INDUSTRY

Sponsor Role: lead

Responsible Party

Rahul Kaliki

Chief Executive Officer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Alberta

Edmonton, Alberta, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Rahul R Kaliki, Ph.D

Role: CONTACT

rahul@i-biomed.com

(443) 451-7175

Facility Contacts

Jacqueline Hebert, MD, FRCPC

Role: primary

jhebert@ualberta.ca

(780) 492-7846

Other Identifiers

W81XWH2010919

Identifier Type: -

Identifier Source: org_study_id