Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date April 2023
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Lucile Packard Children's Hospital Stanford Palo Alto California
United States Stanford Health Care Hospital Stanford California

Sponsors (1)

Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

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
See also
  Status Clinical Trial Phase
Completed NCT04484610 - Appropriate Opioid Quantities for Acute Pain - Pharmacist Study Phase 4
Recruiting NCT05054179 - Pecto-Intercostal Fascial Plane Block Catheter Trial for Reduction of Sternal Pain Phase 2/Phase 3
Completed NCT04548635 - VR for Burn Dressing Changes at Home Phase 2/Phase 3
Recruiting NCT05370404 - Prescribing vs. Recommending Over-The-Counter (PROTECT) Analgesics for Patients With Postoperative Pain: N/A
Completed NCT06054945 - Clinical Impact of IPACK Block Addition to Suprainguinal Fascia Iliaca Block
Completed NCT03825549 - A Randomized Trial of Behavioral Economic Approaches to Reduce Unnecessary Opioid Prescribing N/A
Completed NCT05995912 - Efficacy and Safety of Etoricoxib-tramadol Tablet in Acute Postoperative Pain Phase 2
Recruiting NCT05589246 - Regional Analgesia in Combination With Cryoanalgesia to Prevent Acute Pain Following Nuss Procedure N/A
Recruiting NCT05572190 - Evaluate the Safety and Pharmacokinetic Profile of ETR028 and ETR029 in Healthy Adult Subjects Phase 1
Terminated NCT04716413 - Evaluating the Use of Sublingual Sufentanil in Patients With Suboxone Treatment Phase 4
Active, not recruiting NCT03537573 - Provider-Targeted Behavioral Interventions to Prevent Unsafe Opioid Prescribing for Acute Pain in Primary Care N/A
Not yet recruiting NCT06317844 - Examination of Psychological and Physiological Pathways Linking Gratitude and Pain N/A
Withdrawn NCT02957097 - Gabapentin as a Pre-emptive Analgesic in Oral and Maxillofacial Surgical Procedures Phase 4
Terminated NCT02599870 - Clinical Study to Evaluate Clinical Impact of PGx-Guided Treatment for Patients Undergoing Elective Spinal Surgical Procedures N/A
Completed NCT02565342 - Interscalene Brachial Plexus Block to Treat Pain After Clavicular Surgery Phase 4
Completed NCT02380989 - Integrative Ayurveda Healing Relieves Minor Sports Injury Pain Phase 2
Completed NCT02984098 - 40% Orally Administered Dextrose Gel is More Effective Than 25% Dextrose Phase 4
Completed NCT02489630 - Low Dose Ketamine as an Adjunct to Opiates for Acute Pain in the Emergency Department Phase 4
Completed NCT03107338 - Preventive Treatment of Pain After Dental Implant Surgery Phase 4
Completed NCT02817477 - Intranasal Ketamine for Acute Traumatic Pain Phase 4