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

The University of Alabama at Birmingham

Status and phase: Completed; Phase 1

Conditions: Cerebral Palsy

Treatments: Behavioral: Virtual Reality Exergaming

Study type: Interventional

Funder types: Other

Identifiers

NCT05336227

1R03HD107598-01

Details and patient eligibility

About

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.

Full 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).

Enrollment: 32 patients

Sex: All

Ages: 13 to 24 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 2 patient groups

Immediate Start - Virtual Reality Exergaming

Experimental group

Description:

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.

Treatment:

Behavioral: Virtual Reality Exergaming

Wait-list Control

No Intervention group

Description:

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