Back to resultsVirtual Reality and Spinal Stimulation to Improve Arm Function
Primary Purpose
Tetraplegia
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active (Virtual reality and spinal stimulation)
Sponsored by
About this trial
This is an interventional treatment trial for Tetraplegia focused on measuring upper limb function, virtual reality, spinal cord stimulation
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.
Sites / Locations
- Virginia Commonwealth University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Virtual reality and spinal stimulation
Arm Description
Safety and feasibility of a virtual reality and spinal stimulation intervention will be tested.
Outcomes
Primary Outcome Measures
Change in medical status
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
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
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
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
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
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
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.
Full Information
NCT ID
NCT05065437
First Posted
September 22, 2021
Last Updated
June 28, 2022
Sponsor
Virginia Commonwealth University
1. Study Identification
Unique Protocol Identification Number
NCT05065437
Brief Title
Virtual Reality and Spinal Stimulation to Improve Arm Function
Official Title
Immersive Virtual Reality and Noninvasive Spinal Stimulation to Promote Arm Function in Individuals With Tetraplegia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Withdrawn
Why Stopped
No IRB application has been prepared for this study and other studies have taken priority. The study team will not be working on this study for the foreseeable future.
Study Start Date
June 2022 (Anticipated)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tetraplegia
Keywords
upper limb function, virtual reality, spinal cord stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Virtual reality and spinal stimulation
Arm Type
Experimental
Arm Description
Safety and feasibility of a virtual reality and spinal stimulation intervention will be tested.
Intervention Type
Other
Intervention Name(s)
Active (Virtual reality and spinal stimulation)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in medical status
Description
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.
Time Frame
Baseline to post intervention, approximately 4 weeks
Title
Acceptability of the treatment
Description
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.
Time Frame
Post intervention, approximately 4 weeks
Title
Usability of the treatment
Description
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.
Time Frame
Post intervention, approximately 4 weeks
Secondary Outcome Measure Information:
Title
Change in affect
Description
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."
Time Frame
Baseline to post intervention, approximately 4 weeks
Title
Change in current pain intensity
Description
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").
Time Frame
Baseline to post intervention, approximately 4 weeks
Title
Change in clinical muscle strength
Description
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.
Time Frame
Baseline to post intervention, approximately 4 weeks
Title
Change in upper limb function
Description
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.
Time Frame
Baseline to post intervention, approximately 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carrie Peterson, PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Virtual Reality and Spinal Stimulation to Improve Arm Function
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