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Clinical Trials/NCT03874507
NCT03874507
Completed
Not Applicable

Technology-Based Intervention for Physical Therapy in Pediatric and Adult Populations

Stanford University2 sites in 1 country41 target enrollmentJuly 25, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mobility Limitation
Sponsor
Stanford University
Enrollment
41
Locations
2
Primary Endpoint
Patient and Physical Therapist Feedback
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The purpose of this study is to determine if non-invasive distracting devices (Virtual Reality (VR) headset, Augmented Reality (AR) Headset) are more effective than the standard of care (i.e., no technology-based distraction) for improving clinical outcomes in patients requiring acute rehabilitation due to deconditioning and surgery. Measures will include include range of motion, gait progression, strength progression, time to first out of bed, time to first step.

Registry
clinicaltrials.gov
Start Date
July 25, 2019
End Date
April 25, 2020
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Thomas Caruso

Clinical Associate Professor

Stanford University

Eligibility Criteria

Inclusion Criteria

  • Diagnosis need for physical rehabilitation

Exclusion Criteria

  • Significant Cognitive Impairment
  • History of Severe Motion Sickness
  • Current Nausea
  • Visual Problems
  • Patients whose children are clinically unstable or require urgent/emergent intervention
  • Patients who clinically unstable or requires urgent/emergent intervention

Outcomes

Primary Outcomes

Patient and Physical Therapist Feedback

Time Frame: Survey of patient and PT satisfaction will be administered after the physical therapy session, duration of survey should take approximately 15 minutes or less

Survey of patient and PT satisfaction will be administered after the session. Example of survey questions, to which patient answered 'Yes or No,' for patient include 1) 'The VR game helped me during physical therapy' 2) 'I felt less pain when I moved using the VR game' The survey administered to physical therapists will be rated 1-5 (1=Not at all, 5= A lot) with questions such as 1) 'The technology was helpful to my patients during physical therapy' and 2) 'I would like my patient to have access to this technology for future physical therapy sessions'

Aggregate Movement

Time Frame: Duration of physical therapy, approximately 10 minutes

Aggregate movement will be measured by either sensors in the VR/AR headset or by a physical therapist during the participants session

Patient Fatigue

Time Frame: OMNI PRE Questionnaire will be administered after the physical therapy session, duration of questionnaire should take approximately 15 minutes or less

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-category perceived exertion rating scale with a numerical rating from 0 to 10 (0= Not Tired at All, 10= Very, Very Tired).

Study Sites (2)

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