Telehealth Virtual Reality Exergaming for Spinal Cord Injury

Telehealth Virtual Reality Exergaming and Peer Networking Among People With Spinal Cord Injury

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.

Study Overview

• Status: Withdrawn
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Behavioral: Virtual Reality Gaming

Detailed Description

There are three purposes to this study.

The first purpose is to quantify feasibility through telemonitored exercise data: total play time, moderate exercise time, playtime with others, and compliance to the data collections. These variables will be compared against a priori criteria for acceptability. These variables will help determine whether modifications to the intervention protocol are necessary.

The second purpose is to qualitatively interview participants to explain underlying behavioral mechanisms that affect their participation in the program. This information will be used to explain how to improve implementation issues identified in Aim 1.

The third aim is to explore the potential effects of the program on self-reported psychosocial health and quality of life, hand-grip strength, and cardiometabolic health (blood cholesterol, lipids, pressure, and insulin) measured via home dried blood spot test.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group virtual reality gaming; 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; Peer-to-peer gaming.
No Intervention: Wait-list Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Anxiety and Depression Scale	The Hospital Anxiety and Depression Scale is a 14-item self-report measure that provides separate scores for anxiety and depression. Hospital Anxiety and Depression Scale is a common clinical measure that has strong psychometric properties. Scores range from 0 to 42, where a higher score represents a worse level of depression.	Week 0, Week 5, Week 9
World Health Organization Quality of Life	The World Health Organization Quality of Life is a self-report questionnaire with 26 items that cover 5 dimensions: physical health (7 items); psychological health (6 items); social relationships (3 items); environment (8 items); and overall quality of life (2 items). Raw scores are calculated for each domain on a lilkert scale of 1-5 (low domain score of 3, max domain raw score of 40. Raw scores are then multiplied by 4 to transform the raw score into a scaled score. Higher scores represent higher perceived ratings of quality of life.	Week 0, Week 5, Week 9
Functional Grip Strength	Grip strength will be measured as an indicator of global muscular strength, using a low-cost hand-held dynamometer.	Week 0, Week 5, Week 9
Critical factors that affected adherence	Participants will undergo one-on-one, semi-structured interviews after the intervention to identify critical factors that affected their participation to the intervention.	Intervention Week 9
Changes in blood pressure	Changes in resting home-blood pressure (systolic and diastolic ) measured via blood pressure cuff across the intervention.	Week 0, Week 5, Week 9
Changes in high sensitivity C-reactive protein (hsCRP)	Changes in high sensitivity C-reactive protein measured via blood spot test across the intervention.	Week 0, Week 5, Week 9
Changes in hemoglobin A1c	Changes in hemoglobin A1c measured via blood spot test across the intervention.	Week 0, Week 5, Week 9
Changes in fasting insulin	Changes in fasting insulin levels measured via blood spot test across the intervention.	Week 0, Week 5, Week 9
Changes in fasting triglycerides	Changes in fasting triglycerides levels measured via blood spot test across the intervention.	Week 0, Week 5, Week 9
Changes in total cholesterol	Changes in total cholesterol measured via blood spot test across the intervention.	Week 0, Week 5, Week 9
Changes in low-density lipoprotein (LDL)	Changes in low-density lipoprotein via blood spot test across the intervention.	Week 0, Week 5, Week 9
Changes in high-density lipoprotein (LDL)	Changes in high-density lipoprotein via blood spot test across the intervention.	Week 0, Week 5, Week 9

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2022
• Primary Completion (Actual): April 12, 2022
• Study Completion (Actual): April 13, 2022

Study Registration Dates

• First Submitted: March 22, 2022
• First Submitted That Met QC Criteria: March 31, 2022
• First Posted (Actual): April 8, 2022

Study Record Updates

• Last Update Posted (Actual): April 21, 2022
• Last Update Submitted That Met QC Criteria: April 13, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: IRB-300008605

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No