Back to resultsMixed Reality Gaming for Chronic Low Back Pain
Primary Purpose
Recurrent Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exergaming
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Low Back Pain focused on measuring Walking, Exercise, Exergaming
Eligibility Criteria
Inclusion Criteria:
History of chronic low back pain
Exclusion Criteria:
No major neurological, cardiac, pulmonary, or other orthopedic injuries
Sites / Locations
- University of Alabama at Birmingham
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Exergaming
Arm Description
Outcomes
Primary Outcome Measures
Walking Distance
How far participants walk while playing the game as measured by a meter on the instrumented treadmill.
Secondary Outcome Measures
Walking Speed
How fast participants walk while playing the game by dividing the distance people walked by the amount of time that they walked
Full Information
NCT ID
NCT03603028
First Posted
April 30, 2018
Last Updated
January 13, 2020
Sponsor
University of Alabama at Birmingham
Collaborators
From The Future LLC
1. Study Identification
Unique Protocol Identification Number
NCT03603028
Brief Title
Mixed Reality Gaming for Chronic Low Back Pain
Official Title
Mixed Reality Gaming for Chronic Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
August 17, 2018 (Actual)
Primary Completion Date
September 30, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
From The Future LLC
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
Mixed Reality Gaming for Chronic Low Back Pain
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Low Back Pain
Keywords
Walking, Exercise, Exergaming
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exergaming
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Exergaming
Other Intervention Name(s)
Mixed Reality
Intervention Description
Mixed Reality Gaming for Chronic Low Back Pain
Primary Outcome Measure Information:
Title
Walking Distance
Description
How far participants walk while playing the game as measured by a meter on the instrumented treadmill.
Time Frame
Day 1 through Day 3 of study
Secondary Outcome Measure Information:
Title
Walking Speed
Description
How fast participants walk while playing the game by dividing the distance people walked by the amount of time that they walked
Time Frame
Day 1 - Day 3 of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
History of chronic low back pain
Exclusion Criteria:
No major neurological, cardiac, pulmonary, or other orthopedic injuries
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Brown, PT, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Mixed Reality Gaming for Chronic Low Back Pain
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