Recruiting

Augmented Reality Rehabilitation

Sponsor:

Infinite Biomedical Technologies

Code:

NCT05975970

Conditions

Amputation

Upper Limb

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MyoTrain AR

Motor Imagery

Study Details

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 ID

NCT05975970

Start date

Oct 2, 2023

Status verified date

Jan, 2024

Completion date

Sep, 2024

Anticipated

Primary completion date

Sep, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: 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.

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.

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.

Primary outcome measure

  • GaMA Cup Transfer Task Mean Completion Time [ Time Frame: Day 35 ]
  • GaMA Cup Transfer Task Mean Relative Grasp Duration [ Time Frame: Day 35 ]

Central Contacts and Locations

Central contacts

Rahul R Kaliki, Ph.D

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

Locations

University of Alberta

Recruiting

Edmonton, Alberta, Canada, T6G 2R3

Contacts

Jacqueline Hebert, MD, FRCPC

(780) 492-7846jhebert@ualberta.ca

More Information

Sponsor

Infinite Biomedical Technologies

Last update posted

Jan 10, 2024

Last verified

Jan, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Infinite Biomedical Technologies on 2024-01-10.