Immersive Virtual Reality and Noninvasive Spinal Stimulation to Promote Arm Function in Individuals With Tetraplegia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tetraplegia
- Sponsor
- Virginia Commonwealth University
- Locations
- 1
- Primary Endpoint
- Change in medical status
- Status
- Withdrawn
- Last Updated
- 3 years ago
Overview
Brief Summary
The main objective of our work is to develop and test the safety and feasibility of a home-based upper limb rehabilitation program for individuals with tetraplegia. The program will consist of simultaneous non-invasive spinal cord stimulation and immersive virtual exercises of the upper limbs, with a focus on shoulder and elbow function.
Investigators
Eligibility Criteria
Inclusion Criteria
- •incomplete low tetraplegia (C5-8; \[ASIA\] classification B-D),
- •free of contraindications to transspinal stimulation,
- •more than one-year post-injury,
- •stable medication regimen for the past month,
- •utilization of wheelchair as a primary mode of mobility (\>75% of the time). -
Exclusion Criteria
- •Neurologic injury other than spinal cord injury
- •severe medical illness.
Outcomes
Primary Outcomes
Change in medical status
Time Frame: Baseline to post intervention, approximately 4 weeks
Safety of the intervention will be assessed as the number of participants who experience a reduction in medical stability and/or functionality from before to after the intervention.
Acceptability of the treatment
Time Frame: Post intervention, approximately 4 weeks
Acceptability of the treatment will be assessed using the Treatment Evaluation Inventory-Short Form. Items are scored using a 5-point scale, with 1 equaling strongly disagree and 5 equaling strongly agree. TEI-SF scores can range from 9 to 45, with higher scores representing greater acceptance of the treatment.
Usability of the treatment
Time Frame: Post intervention, approximately 4 weeks
Usability of the treatment will be assessed using the Usefulness, Satisfaction, and Ease of Use (USE) Questionnaire. Items are rated on a seven-point scale ranging from strongly disagree to strongly agree. A higher scale score indicates higher usability.
Secondary Outcomes
- Change in clinical muscle strength(Baseline to post intervention, approximately 4 weeks)
- Change in current pain intensity(Baseline to post intervention, approximately 4 weeks)
- Change in upper limb function(Baseline to post intervention, approximately 4 weeks)
- Change in affect(Baseline to post intervention, approximately 4 weeks)