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Physical Therapy Using Virtual Reality/Augmented Reality

Primary Purpose

Mobility Limitation, Spinal Fusion, Acute Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality/Augmented Reality Headset
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Mobility Limitation focused on measuring virtual reality, augmented reality, physical therapy, deconditioning

Eligibility Criteria

6 Years - 99 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 6-99
  • Diagnosis need for physical rehabilitation

Exclusion Criteria:

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

Sites / Locations

  • Lucile Packard Children's Hospital Stanford
  • Stanford Health Care Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Technology-based therapy

Standard of Care therapy

Arm Description

Patients who require acute rehabilitation due to deconditioning and surgery will receive either virtual reality (VR) or augmented reality (AR) to improve clinical outcomes such as range of motion, gait progression, strength progression, time to first out of bed, time to first step.

Patients who require acute rehabilitation due to deconditioning and surgery will receive physical therapy based on his/her providers recommendations to improve outcomes such as range of motion, gait progression, strength progression, time to first out of bed, time to first step

Outcomes

Primary Outcome Measures

Aggregate Movement
Aggregate movement will be measured by either sensors in the VR/AR headset or by a physical therapist during the participants session
Patient and Physical Therapist Feedback
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'
Patient Fatigue
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).

Secondary Outcome Measures

Full Information

First Posted
March 12, 2019
Last Updated
April 12, 2023
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT03874507
Brief Title
Physical Therapy Using Virtual Reality/Augmented Reality
Official Title
Technology-Based Intervention for Physical Therapy in Pediatric and Adult Populations
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
July 25, 2019 (Actual)
Primary Completion Date
April 25, 2020 (Actual)
Study Completion Date
April 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mobility Limitation, Spinal Fusion, Acute Pain
Keywords
virtual reality, augmented reality, physical therapy, deconditioning

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Technology-based therapy
Arm Type
Experimental
Arm Description
Patients who require acute rehabilitation due to deconditioning and surgery will receive either virtual reality (VR) or augmented reality (AR) to improve clinical outcomes such as range of motion, gait progression, strength progression, time to first out of bed, time to first step.
Arm Title
Standard of Care therapy
Arm Type
No Intervention
Arm Description
Patients who require acute rehabilitation due to deconditioning and surgery will receive physical therapy based on his/her providers recommendations to improve outcomes such as range of motion, gait progression, strength progression, time to first out of bed, time to first step
Intervention Type
Other
Intervention Name(s)
Virtual Reality/Augmented Reality Headset
Intervention Description
A virtual reality (VR) headset is a device the participant will wear over his/her head and eyes like a pair of goggles. It blocks out all external light and shows him/her an image on high-definition screens in front of his/hers eyes. It implies a complete immersion experience that shuts out the physical world. Augmented reality (AR) headset is a device that the participant will wear over his/hers head and eyes and it adds digital elements to a live view.
Primary Outcome Measure Information:
Title
Aggregate Movement
Description
Aggregate movement will be measured by either sensors in the VR/AR headset or by a physical therapist during the participants session
Time Frame
Duration of physical therapy, approximately 10 minutes
Title
Patient and Physical Therapist Feedback
Description
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'
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
Title
Patient Fatigue
Description
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).
Time Frame
OMNI PRE Questionnaire will be administered after the physical therapy session, duration of questionnaire should take approximately 15 minutes or less

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 6-99 Diagnosis need for physical rehabilitation Exclusion Criteria: Significant Cognitive Impairment History of Severe Motion Sickness Current Nausea Seizures Visual Problems Patients whose children are clinically unstable or require urgent/emergent intervention Patients who clinically unstable or requires urgent/emergent intervention
Facility Information:
Facility Name
Lucile Packard Children's Hospital Stanford
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Stanford Health Care Hospital
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33935153
Citation
Hemphill S, Rodriguez S, Wang E, Koeppen K, Aitken-Young B, Jackson C, Simons L, Caruso TJ. Virtual Reality Augments Movement During Physical Therapy: A Pragmatic Randomized Trial. Am J Phys Med Rehabil. 2022 Mar 1;101(3):229-236. doi: 10.1097/PHM.0000000000001779.
Results Reference
derived

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Physical Therapy Using Virtual Reality/Augmented Reality

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