A Patient-Driven Augmented Reality-Based Rehabilitation System to Improve Upper Limb Amputee Outcomes
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Amputation
- Sponsor
- Infinite Biomedical Technologies
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- GaMA Cup Transfer Task Mean Completion Time
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Rahul Kaliki
Chief Executive Officer
Infinite Biomedical Technologies
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
Outcomes
Primary Outcomes
GaMA Cup Transfer Task Mean Completion Time
Time Frame: Day 35
The time to successfully complete the entire task trial (all 4 cup movements) from start to finish; averaged over all successful trials.
GaMA Cup Transfer Task Mean Relative Grasp Duration
Time Frame: Day 35
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.
Secondary Outcomes
- 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)