Virtual Reality and Spinal Stimulation to Improve Arm Function

Not Applicable

Withdrawn

• Conditions: Tetraplegia
• Interventions: Other: Active (Virtual reality and spinal stimulation)

• Registration Number: NCT05065437
• Lead Sponsor: Virginia Commonwealth University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-22
• Study First Submitted QC: 2021-10-01
• Study First Posted: 2021-10-04
• Status Verified: 2022-06
• Study Start: 2022-06
• Last Update Submitted: 2022-06-28
• Last Update Posted: 2022-07-01
• Primary Completion: 2024-01-01
• Study Completion: 2024-01-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Virtual reality and spinal stimulation	Active (Virtual reality and spinal stimulation)	Safety and feasibility of a virtual reality and spinal stimulation intervention will be tested.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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 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 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."

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States