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Physical Therapy Using Virtual Reality/Augmented Reality

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ClinicalTrials.gov Identifier: NCT03874507
Recruitment Status : Not yet recruiting
First Posted : March 14, 2019
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Thomas Caruso, Stanford University

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.

Condition or disease Intervention/treatment Phase
Mobility Limitation Spinal Fusion Acute Pain Other: Virtual Reality/Augmented Reality Headset Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Technology-Based Intervention for Physical Therapy in Pediatric and Adult Populations
Estimated Study Start Date : May 15, 2019
Estimated Primary Completion Date : May 15, 2020
Estimated Study Completion Date : May 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
Experimental: Technology-based therapy
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.
Other: Virtual Reality/Augmented Reality Headset

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.


No Intervention: Standard of Care therapy
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



Primary Outcome Measures :
  1. Range of motion [ Time Frame: Duration of physical therapy, approximately 1 hour ]
    Range of motion will be measured by either sensors in the VR/AR headset or by a physical therapist during the participants session

  2. Time to first out of bed [ Time Frame: End of surgery until time out of bed, approximately 4-5 days ]
    The time it takes the patient to stand from bed will be measured by provider using time end of surgical procedure until participant gets out of bed for first time

  3. Time to first step [ Time Frame: End of surgery until time to first step, approximately 4-5 days ]
    The time it takes the patient to take first step post-surgery will be measured by provider using time end of surgical procedure until participant gets out of bed and takes first step



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Ages Eligible for Study:   6 Years to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03874507


Contacts
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Contact: Ahtziri Fonseca, BS 6504970927 aef22011@stanford.edu
Contact: Maria Menendez mamenendez@stanfordchildrens.org

Locations
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United States, California
Lucile Packard Children's Hospital Stanford Not yet recruiting
Palo Alto, California, United States, 94304
Contact: Ahtziri Fonseca         
Contact: Ahtziri Fonseca    6504970927    aef22011@stanford.edu   
Stanford Health Care Hospital Not yet recruiting
Stanford, California, United States, 94304
Contact: Ahtziri Fonseca    650-497-0927    aef22011@stanford.edu   
Sponsors and Collaborators
Stanford University

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Responsible Party: Thomas Caruso, Clinical Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT03874507     History of Changes
Other Study ID Numbers: 50159
First Posted: March 14, 2019    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Thomas Caruso, Stanford University:
virtual reality
augmented reality
physical therapy
deconditioning

Additional relevant MeSH terms:
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Acute Pain
Mobility Limitation
Pain
Neurologic Manifestations
Signs and Symptoms