Virtual Reality and Spinal Stimulation to Improve Arm Function
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Virtual reality and spinal stimulation Safety and feasibility of a virtual reality and spinal stimulation intervention will be tested. |
Other: Active (Virtual reality and spinal stimulation)
Each session is 25 minutes; 5 minutes of setup, and 20 minutes of simultaneous spinal stimulation at the cervical level and immersive virtual experience/gameplay.
|
Outcome Measures
Primary Outcome Measures
- Change in medical status [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 [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 [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 Outcome Measures
- Change in affect [Baseline to post intervention, approximately 4 weeks]
Affect will be assessed using the Positive and Negative Affect Schedule (PANAS). The PANAS is a 20-item measure that measures the intensity of 20 emotions on a 0-5 scale ranging from "not at all" to "extremely."
- Change in current pain intensity [Baseline to post intervention, approximately 4 weeks]
Current pain intensity will be assessed using a Numeric Rating Scale (NRS). Participants will rate their current pain (multiple types of pain) on a 0-10 scale (0 = "no pain" and 10 = "worst possible pain").
- Change in clinical muscle strength [Baseline to post intervention, approximately 4 weeks]
Clinical muscle strength will be assessed using the American Spinal Cord Injury Association (ASIA) Upper Extremity Motor Score. Motor strength is rated on a 6 point scale with higher ratings indicating greater strength.
- Change in upper limb function [Baseline to post intervention, approximately 4 weeks]
Upper limb function will be assessed using the Spinal Cord Independence Measure (SCIM). The SCIM is composed of 19 items that assess function. SCIM scores range from 0 to 100.
Eligibility Criteria
Criteria
Inclusion Criteria:
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incomplete low tetraplegia (C5-8; [ASIA] classification B-D),
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free of contraindications to transspinal stimulation,
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more than one-year post-injury,
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stable medication regimen for the past month,
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utilization of wheelchair as a primary mode of mobility (>75% of the time). -
Exclusion Criteria:
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Neurologic injury other than spinal cord injury
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severe medical illness.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Virginia Commonwealth University | Richmond | Virginia | United States | 23298 |
Sponsors and Collaborators
- Virginia Commonwealth University
Investigators
- Principal Investigator: Carrie Peterson, PhD, Virginia Commonwealth University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FP00015240