Virtual Reality and Spinal Stimulation to Improve Arm Function

NCT05065437 | Withdrawn DMC

• 1 other identifier: FP00015240
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Tetraplegia

Keywords

upper limb function; virtual reality; spinal cord stimulation

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline to post intervention, approximately 4 weeks

• 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.

  Post intervention, approximately 4 weeks

• 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.

  Post intervention, approximately 4 weeks

Secondary Outcomes (4)

• Change in affect

  Baseline to post intervention, approximately 4 weeks

• Change in current pain intensity

  Baseline to post intervention, approximately 4 weeks

• Change in clinical muscle strength

  Baseline to post intervention, approximately 4 weeks

• Change in upper limb function

  Baseline to post intervention, approximately 4 weeks

Study Arms (1)

Virtual reality and spinal stimulation

EXPERIMENTAL

Safety and feasibility of a virtual reality and spinal stimulation intervention will be tested.

Other: Active (Virtual reality and spinal stimulation)

Interventions

Active (Virtual reality and spinal stimulation) OTHER

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.

Virtual reality and spinal stimulation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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). -

You may not qualify if:

• Neurologic injury other than spinal cord injury
• severe medical illness.

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Quadriplegia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Carrie Peterson, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 4, 2021
• Study Start: June 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: July 1, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)