- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03603028
Mixed Reality Gaming for Chronic Low Back Pain
January 13, 2020 updated by: David A Brown, University of Alabama at Birmingham
Mixed Reality Gaming for Chronic Low Back Pain
Study Overview
Detailed Description
The company, From the Future and University of Alabama at Birmingham (UAB) team aimed to develop a virtual reality (VR) game that integrated with the features of a specialized self-driven treadmill to provide accessible and progressive walking challenges for individuals with chronic low back pain (LBP).
The game was designed to go beyond typical VR research efforts and provide a truly immersive and engaging experience that would motivate individuals with high pain-related fear to keep moving.
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35294
- University of Alabama at Birmingham
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
History of chronic low back pain
Exclusion Criteria:
No major neurological, cardiac, pulmonary, or other orthopedic injuries
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Exergaming
|
Mixed Reality Gaming for Chronic Low Back Pain
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Walking Distance
Time Frame: Day 1 through Day 3 of study
|
How far participants walk while playing the game as measured by a meter on the instrumented treadmill.
|
Day 1 through Day 3 of study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Walking Speed
Time Frame: Day 1 - Day 3 of study
|
How fast participants walk while playing the game by dividing the distance people walked by the amount of time that they walked
|
Day 1 - Day 3 of study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: David Brown, PT, PhD, University of Alabama at Birmingham
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 17, 2018
Primary Completion (ACTUAL)
September 30, 2018
Study Completion (ACTUAL)
September 30, 2018
Study Registration Dates
First Submitted
April 30, 2018
First Submitted That Met QC Criteria
July 25, 2018
First Posted (ACTUAL)
July 27, 2018
Study Record Updates
Last Update Posted (ACTUAL)
January 22, 2020
Last Update Submitted That Met QC Criteria
January 13, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- F89635687
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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