Telehealth Virtual Reality Gaming on Cardiometabolic Health Among Youth With Cerebral Palsy

NCT ID: NCT05336227

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2025-02-11

Brief Summary

The primary purpose of this study is to examine the preliminary efficacy of 12-weeks of home-based exercise using consumer available virtual reality gaming technology, compared with a 12 week wait-list control group. The secondary purpose is to understand behavioral mechanisms that explain participation in exergaming through semi-structured interviews with participants from both groups at post-intervention or dropout.

Detailed Description

Youth with cerebral palsy (YwCP) do not have adequate exercise options that empower them to independently maintain their cardiometabolic health and, thus, live inactive, sedentary lifestyles that place them at substantially higher risk for cardiovascular disease, related conditions (e.g., hypercholesterolemia, diabetes, and hypertension), and mortality than the general population. No randomized controlled trial (RCT) has demonstrated clinically meaningful improvements in cardiometabolic health in people with cerebral palsy.

VR gaming delivered via telehealth may be an optimal method of promoting sustainable exercise behavior among large groups of youth. Home-based telehealth programs that incorporate 'virtual' behavioral coaching (tele-coaching) are a desirable approach for promoting non-supervised, exercise behavior among people with disabilities who do not have convenient access to community programs. The addition of behavioral coaching strategies such as goal-setting, confidence building, setting reasonable expectations, and understanding benefits, underpinned by theory such as the Social Cognitive Theory (Bandura, 2004), have been found to enhance the likelihood that people engage in and sustain a behavior.

Therefore, this study hypothesizes that 3-months of tele-monitored VR exergaming with behavioral coaching will result in strong adherence to moderate-intensity exercise and greater changes in key indicators of cardiometabolic health in YwCP, compared with a wait-list control group that maintains habitual activity (before receiving the intervention).

Conditions

Cerebral Palsy

Study Design

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

Study Groups

Immediate Start - Virtual Reality Exergaming

12 weeks of virtual reality active video gaming using immersive commercially available equipment, with adapted games for people to play in the seated position. Maintain normal eating/nutritional behaviors.

Group Type: EXPERIMENTAL

Virtual Reality Exergaming

Intervention Type: BEHAVIORAL

The VR intervention will include home-based exercise using the Oculus Quest, a heart rate monitor (Polar OH1), BP cuff, and mobile application. The games will include rhythmic movements to music and sport/recreation activities that elicit high energy expenditure. Participants will be instructed to reach 150 minutes per week of moderate-exercise in week 1 and maintain this volume across the 12-week intervention. The intervention will include behavioral, physical education coaching through videoconference, which we refer to as Tele-PE. Tele-PE will aim to enhance adherence, provide basic exercise knowledge, and increase mastery playing the games. Calls will last 15 minutes, and be provided weekly in month 1, bi-weekly in month 2, and one call at the end of month 3.

Wait-list Control

Maintain habitual physical activity levels for 12 weeks, before receiving the same intervention. Maintain normal eating/nutritional behaviors.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Virtual Reality Exergaming

The VR intervention will include home-based exercise using the Oculus Quest, a heart rate monitor (Polar OH1), BP cuff, and mobile application. The games will include rhythmic movements to music and sport/recreation activities that elicit high energy expenditure. Participants will be instructed to reach 150 minutes per week of moderate-exercise in week 1 and maintain this volume across the 12-week intervention. The intervention will include behavioral, physical education coaching through videoconference, which we refer to as Tele-PE. Tele-PE will aim to enhance adherence, provide basic exercise knowledge, and increase mastery playing the games. Calls will last 15 minutes, and be provided weekly in month 1, bi-weekly in month 2, and one call at the end of month 3.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. medical diagnosis of cerebral palsy

2. between the ages of 13-24 years to accommodate the World Health Organization definition of youth and the minimum age of 13 years specified by the Quest

3. physician clearance to participate

4. access to a Wi-Fi Internet connection in the home via mobile phone or tablet computer

5. a caregiver to support the child

Exclusion Criteria

1. physically active (defined as >150 minutes per week of moderate-to-vigorous intensity exercise in a typical week)

2. cannot use their arms for exercise or a classification of GMFCS level V, which we have found to preclude the ability to use the Oculus Quest hand-held controllers

3. complete blindness or deafness.

4. contraindications to exercise based on the American College of Sports Medicine (ACSM) guidelines

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Byron Lai

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Byron Lai, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

Children's Hospital of Alabama

Birmingham, Alabama, United States

Countries

United States

References

Lai B, Davis D, Young R, Kimani-Swanson E, Wozow C, Wen H, Kim Y, Wilroy J, Rimmer J. The Effects of Virtual Reality Tele-exergaming on Cardiometabolic Indicators of Health Among Youth With Cerebral Palsy: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2022 Aug 17;11(8):e40708. doi: 10.2196/40708.

Reference Type: DERIVED

PMID: 35976192 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1R03HD107598-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

300007833

Identifier Type: -

Identifier Source: org_study_id