Immersive Technology to Improve Physical Therapy Engagement

NCT06140121 | Completed

• 1 other identifier: 72980
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This is an experimental study to evaluate the efficacy of a Virtual Reality aid Physical Therapy (VRPT) in increasing the physical activity levels and quality of life of children.

Conditions

Physical Health

Keywords

Virtual Reality; Physical Activity

Outcome Measures

Primary Outcomes (1)

• ActiGraph data points

  Compare the total Metabolic Equivalent of Task (METs) rate of pediatric patients when undergo virtual reality assisted physical therapy and traditional physical therapy measured by ActiGraph watch

  During physical therapy session

Secondary Outcomes (10)

• Total movement with wearable movement sensor

  During physical therapy session

• Perceived exertion

  baseline, during physical therapy session, immediately after the physical therapy session

• Difference in Fatigue - Short Form 10a questionnaire result

  immediately after the physical therapy session

• Change in current mental well being as measured by the modified WHO (Five) Well-Being Index

  immediately after the physical therapy session

• Acceptability of Intervention Measure (AIM)

  immediately after the physical therapy session

Study Arms (2)

Experimental: VRPT then Traditional PT

EXPERIMENTAL

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.

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

Traditional PT then VRPT

EXPERIMENTAL

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

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

Interventions

Virtual Reality Physical Therapy BEHAVIORAL

Participants are allowed to freely choose one game from the game list. Participant will be asked to wear a validated activity tracker - ActiGraph. Baseline heart rate will be collected for 1 minute. Participants will be wearing the ActiGraph during Physical Therapy session. Participants receiving VR intervention will be instructed to wear an Oculus Quest 2 headset (Meta, Inc., Menlo Park, CA) and participate in VR applications under the supervision of the physical therapist.

Also known as: VRPT

Experimental: VRPT then Traditional PT; Traditional PT then VRPT

Traditional Physical Therapy BEHAVIORAL

Participants will receive traditional Physical Therapy sessions (standard care) under the supervision of the accredited physical therapist. Participants will be wearing the Actigraph during Physical Therapy session. Participants will perform regular physical exercise, such as 20 minutes walking or biking on a stationary bike, under the supervision of a physical therapist.

Experimental: VRPT then Traditional PT; Traditional PT then VRPT

Eligibility Criteria

• Age: 7 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Between age 7-25
• has an active physical therapy consultation
• Anticipated inpatient stay for more than 2 days

You may not qualify if:

• Legal guardian 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 cause by flashing light
• Major surgery within the last 48 hours

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Lucile Packard Childrens Hospital Stanford

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Thomas Caruso

  Stanford University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: November 18, 2023
• Study Start: March 13, 2024
• Primary Completion: February 7, 2025
• Study Completion: February 7, 2025
• Last Updated: January 27, 2026

Record last verified: 2026-01

Locations

US (1)