Acute Pain Clinical Trial
Official title:
Technology-Based Intervention for Physical Therapy in Pediatric and Adult Populations
NCT number | NCT03874507 |
Other study ID # | 50159 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 25, 2019 |
Est. completion date | April 25, 2020 |
Verified date | April 2023 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 41 |
Est. completion date | April 25, 2020 |
Est. primary completion date | April 25, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 99 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Lucile Packard Children's Hospital Stanford | Palo Alto | California |
United States | Stanford Health Care Hospital | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Aggregate Movement | Aggregate movement will be measured by either sensors in the VR/AR headset or by a physical therapist during the participants session | Duration of physical therapy, approximately 10 minutes | |
Primary | 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' | Survey of patient and PT satisfaction will be administered after the physical therapy session, duration of survey should take approximately 15 minutes or less | |
Primary | 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). | OMNI PRE Questionnaire will be administered after the physical therapy session, duration of questionnaire should take approximately 15 minutes or less |
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