Tetraplegia
Conditions
Keywords
upper limb function, virtual reality, spinal cord stimulation
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.
Interventions
OTHERActive (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.
Sponsors
Virginia Commonwealth University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. incomplete low tetraplegia (C5-8; \[ASIA\] classification B-D), 2. free of contraindications to transspinal stimulation, 3. more than one-year post-injury, 4. stable medication regimen for the past month, 5. utilization of wheelchair as a primary mode of mobility (\>75% of the time). -
Exclusion criteria
1. Neurologic injury other than spinal cord injury 2. severe medical illness.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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. |
Countries
United States
Outcome results
None listed