Immersive Technology to Improve Physical Therapy Engagement

Not Applicable

Recruiting

• Conditions: Physical Health

• Registration Number: NCT06140121
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-09
• Study First Submitted QC: 2023-11-14
• Study First Posted: 2023-11-18
• Study Start: 2024-03-13
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-19
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
ActiGraph data points	During physical therapy session	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

Secondary Outcome Measures

Name	Time	Method
Patient Fatigue	immediately after the physical therapy session	Patients will self-report fatigue according to the Adult OMNI-Walk/Run RPE Scale (OMNI RPE) scale after both the VR and standard of care portion. The OMNI RPE is an 11-categories perceived exertion rating scale with a numerical rating from 0 to 10 (0= Not Tired at All, 10= Very, Very Tired).
Change in current mental well being as measured by the modified WHO (Five) Well-Being Index	immediately after the physical therapy session	The modified WHO (Five) Well-Being Index is a participant-reported outcome measure that assesses current mental well being. Questionnaire contains 5 questions . Scores range from 0 to 5, with higher scores indicating the corresponding feeling exists all the time
Difference in Fatigue - Short Form 10a questionnaire result	immediately after the physical therapy session	Measured by comparison PROMIS Pediatric Item Bank GenPop v3.0 - Fatigue - Short Form 10a of patient in first physical therapy session and second physical therapy session .; PROMIS Pediatric Item Bank GenPop v3.0 - Fatigue - Short Form 10a is a 10 items -questionnaire which measures the fatigue scale of the patient with scores range from 1 to 5,(1 = never and 5 = Almost always).
Total movement with wearable movement sensor	During physical therapy session	Compare the total movement of pediatric patients when undergo virtual reality assisted physical therapy and traditional physical therapy measured by ActiGraph watch
Difference in FACIT-F questionnaire result	immediately after the physical therapy session	Measured by comparison Pediatric Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) of patient in first physical therapy session and second physical therapy session .; Pediatric Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) is a 13 items -questionnaire which measures the fatigue scale of the patient with minimum score at 0 (low fatigue score) and maximum score at 52 (high fatigue score).

Trial Locations

Locations (1)

Lucile Packard Childrens Hospital Stanford; 🇺🇸 Palo Alto, California, United States