iMOVE: Virtual Reality PT Versus Traditional PT

Stanford University

Status: Not yet enrolling

Conditions: Physical Health

Treatments: Behavioral: Virtual Reality Physical Therapy; Behavioral: Traditional Physical Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05876156

70481

Details and patient eligibility

About

This pragmatic, crossover, randomized controlled study evaluates the efficacy of virtual reality assisted physical therapy (VRPT) for improving the physical activity of hospitalized children as compared to traditional physical therapy. This is a pilot study that will be used to identify patient populations that can benefit the most from VRPT and estimate this effect for future studies.

Patients with a significant neurological condition, major developmental disability, active infection of the face or hand, history of severe motion sickness, history of seizures caused by flashing light or had a major surgery within the last 48 hours will be excluded.

Full description

Childhood cancer is a significant health concern worldwide. Despite improved 5-year survival rates (80%-85%), children undergoing treatment face physiological and psychosocial challenges, including chronic pain, limited mobility, muscle loss, low bone density, and mental distress. To mitigate negative therapy-related adverse health outcomes and improve quality of life, supportive care measures are emphasized during cancer treatments. The US Department of Health & Human Services advises Pediatric oncology patients to engage in 30 minutes of moderate-intensity physical activity, 3 times a week, for a healthy lifestyle. Regular exercise during and after treatment profoundly impacts a child's physical, psychological, and social well-being. Inpatient and outpatient physical therapy is commonly suggested for patients. Yet, traditional physical therapy is usually monotonous and repetitive, leading to boredom and decreased adherence. Limited exercise variation may fail to captivate attention and provide motivation for consistent participation.

Virtual reality physical therapy (VRPT) provides dynamic and interactive exercise, overcoming traditional therapy's boredom. Exergaming offers fun and excitement through engaging virtual environments and gameplay. It enhances motivation, sustains interest, and encourages longer exercise. Personalized and adaptive interventions in virtual reality target individual needs and allow progress tracking.

Enrollment: 40 estimated patients

Sex: All

Ages: 10 to 25 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Between age 10-25 years
• Diagnosed with cancer
• Has an active physical therapy consultation
• Anticipated inpatient stay for at least 3-days with the second PT session following between 24-72 hours after the first PT session
• Ability to understand and the willingness to personally sign the written Institutional Review Board (IRB) approved informed consent document by Legally Authorized Representative (LAR) if participant <18 years old or by participant if 18+
• Ability to understand and the willingness to personally sign the written IRB approved informed assent document for patient <18 years old.

Exclusion criteria

• Legal guardian does not present to obtain consent.
• Child with a significant neurological condition, or major developmental disability.
• Child with active infection of the face or hand.
• A history of severe motion sickness.
• A history of seizures caused by flashing light.
• Major surgery within the last 48 hours.
• Does not speak English (required for surveys)
• With visual impairments or any degree of developmental delays
• Child on mechanical ventilation or ventilatory support

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

VRPT then Traditional PT

Experimental group

Description:

Participants will receive Virtual Reality assisted Physical Therapy sessions (VRPT) in the first Physical Therapy (PT) session and will receive traditional Physical Therapy sessions (standard care) in the second Physical Therapy session under the supervision of the accredited physical therapist.

Treatment:

Behavioral: Traditional Physical Therapy

Behavioral: Virtual Reality Physical Therapy

Traditional PT then VRPT

Experimental group

Description:

Participants will receive traditional Physical Therapy (PT) sessions (standard care) in the first Physical Therapy session and Virtual Reality assisted Physical Therapy sessions (VRPT) in the second Physical Therapy session under the supervision of the accredited physical therapist.

Treatment:

Behavioral: Traditional Physical Therapy

Behavioral: Virtual Reality Physical Therapy