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

NCT05975970 | Unknown DMC

• 1 other identifier: W81XWH2010919
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

amputation; upper limb; myoelectric; training; prosthesis; augmented reality

Outcome Measures

Primary Outcomes (2)

• GaMA Cup Transfer Task Mean Completion Time

  The time to successfully complete the entire task trial (all 4 cup movements) from start to finish; averaged over all successful trials.

  Day 35

• GaMA Cup Transfer Task Mean Relative Grasp Duration

  The percentage time spent in grasp phase relative to the entire movement (each movement involves reach-grasp-transport-release phases). This measure compensates for the expected inter-relation of absolute grasp duration with overall time, specifically identifying if grasp (object handling) is the main culprit in overall prolonged movement times.

  Day 35

Secondary Outcomes (3)

• Assessment of Capacity for Myoelectric Controls (ACMC)

  Day 35

• GaMA Cup Transfer Task Completion Rate

  Day 35

• GaMA Cup Transfer Task Wrist Activation

  Day 35

Study Arms (2)

MyoTrain AR System

EXPERIMENTAL

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.

Device: MyoTrain AR

Conventional Motor Imagery

ACTIVE COMPARATOR

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.

Behavioral: Motor Imagery

Interventions

MyoTrain AR 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.

MyoTrain AR System

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.

Conventional Motor Imagery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Infinite Biomedical Technologies: lead
• United States Department of Defense: collaborator
• University of Alberta: collaborator

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2R3, Canada

RECRUITING

Central Study Contacts

Rahul R Kaliki, Ph.D

CONTACT

(443) 451-7175; rahul@i-biomed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Executive Officer

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: August 4, 2023
• Study Start: October 2, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: January 10, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)