Telehealth Virtual Reality Exergaming for Spinal Cord Injury

NCT05318079 | Withdrawn

• 1 other identifier: IRB-300008605
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This pilot feasibility study aims to test whether youth and adults with spinal cord injury can use a group virtual reality gaming intervention to exercise. A second purpose is to examine whether there are potential benefits to cardiometabolic health and psychosocial health.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (5)

• Total play time

  Percentage of the 300 minutes of prescribed play per week across the intervention.

  Intervention Week 1 - Week 8

• Total exercise time

  Moderate exercise minutes where prescription was met (percent of prescription achieved: weeks where the ≥90 minutes of moderate intensity exercise per week was achieved across the intervention, divided by total weeks).

  Intervention Week 1 - Week 8

• Playtime with others

  Measured by the number of play sessions with other players (online multiplayer and/or peer-gaming). This number will be totaled across the 8-week intervention and divided by 16 (the exercise prescription of 2 x per week of multiplayer gaming).

  Intervention Week 1 - Week 8

• Compliance to baseline data collection

  Number of pre data collections completed, converted into a percentage dividing by the total possible.

  Week 0

• Compliance to post data collections

  Number of pre data collections completed, converted into a percentage dividing by the total possible.

  Week 9

Secondary Outcomes (12)

• Hospital Anxiety and Depression Scale

  Week 0, Week 5, Week 9

• World Health Organization Quality of Life

  Week 0, Week 5, Week 9

• Functional Grip Strength

  Week 0, Week 5, Week 9

• Critical factors that affected adherence

  Intervention Week 9

• Changes in blood pressure

  Week 0, Week 5, Week 9

Study Arms (2)

Group virtual reality gaming

EXPERIMENTAL

The intervention will include home-based exercise using the Oculus Quest 2. Participants will be prescribed two gaming goals to achieve across the 8-week intervention. The first goal will be to play with the Quest for at least ≥60 minutes, 5 days per week (Monday - Friday) across the 8-week intervention: a total of 300 minutes. Participants can achieve these goals through either single- or multiplayer gaming but will be prescribed to engage in online multiplayer or peer-to-peer gaming at least 2 days per week.

Behavioral: Virtual Reality Gaming

Wait-list Control

NO INTERVENTION

People who are randomized to the waitlist group will undergo 4-weeks of wait (habitual daily activities), followed by 8-weeks of VR intervention. People in the wait-group will be in the study for a total of 12 weeks.

Interventions

Virtual Reality Gaming BEHAVIORAL

Peer-to-peer gaming.

Group virtual reality gaming

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• medical diagnosis of traumatic spinal cord injury (determined by International Classification of Disease \[ICD\] codes)
• a caregiver to support the participant if the participant is a child (\<18 years of age)
• access to a Wi-Fi Internet connection in the home

You may not qualify if:

• physically active (defined as \>150 minutes per week of moderate-to-vigorous intensity exercise in a typical week)
• cannot use the arms for exercise or operate the controller buttons using their fingers
• complete blindness or deafness
• recent myocardial infarction or electrocardiography changes, complete heart block, acute congestive heart failure, unstable angina, and uncontrolled severe hypertension \[BP \>/= 180/110 mmHg\]
• prone to seizures

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: April 8, 2022
• Study Start: April 1, 2022
• Primary Completion: April 12, 2022
• Study Completion: April 13, 2022
• Last Updated: April 21, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share