Telehealth Virtual Reality Exergaming for Spinal Cord Injury

NCT ID: NCT05318079

Last Updated: 2022-04-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2022-04-13

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.

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.

Conditions

Spinal Cord Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Virtual Reality Gaming

Intervention Type: BEHAVIORAL

Peer-to-peer gaming.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Virtual Reality Gaming

Peer-to-peer gaming.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Byron Lai

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

IRB-300008605

Identifier Type: -

Identifier Source: org_study_id