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

Last updated: January 8, 2024
Sponsor: Infinite Biomedical Technologies
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

MyoTrain AR

Motor Imagery

Clinical Study ID

NCT05975970
W81XWH2010919
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 thestudy as determined upon clinical evaluation
  • Uncontrolled pain or phantom pain impactive full participation in the study asdetermined upon clinical evaluation
  • Serious uncontrolled medical problems as judged by the project therapist

Study Design

Total Participants: 10
Treatment Group(s): 2
Primary Treatment: MyoTrain AR
Phase:
Study Start date:
October 02, 2023
Estimated Completion Date:
September 30, 2024

Connect with a study center

  • University of Alberta

    Edmonton, Alberta T6G 2R3
    Canada

    Active - Recruiting

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