Mixed Reality Gaming for Chronic Low Back Pain

NCT03603028 — Not applicable, Completed, 13 participants, University of Alabama at Birmingham

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Registry	NCT03603028
Status	Completed
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	13 (Actual)
Sponsor	University of Alabama at Birmingham (Other); collaborators: From The Future LLC
Conditions	Recurrent Low Back Pain
Interventions	Exergaming (Device)
Dates	start 2018-08-17, primary completion 2018-09-30, completion 2018-09-30, first posted 2018-07-27, last updated 2020-01-22
Locations	1 site in United States

-Summary

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Exergaming	Experimental	Device: Exergaming

Exergaming (Device), also known as Mixed Reality: Mixed Reality Gaming for Chronic Low Back Pain

+Outcome measures

Primary outcomes

Walking Distance [Day 1 through Day 3 of study]: How far participants walk while playing the game as measured by a meter on the instrumented treadmill.

Secondary outcomes

Walking Speed [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

+Eligibility

Sex: All, ages: 18 Years to 65 Years

Inclusion Criteria:

History of chronic low back pain

Exclusion Criteria:

No major neurological, cardiac, pulmonary, or other orthopedic injuries

+Posted results

Participant flow

Milestone	Exergaming
Started	13
Completed	12
Not completed	1

Outcome results

Walking Distance (Primary), Mean, meters: Exergaming 1,134.24 +/- 200.14
Walking Speed (Secondary), Mean, meters per second: Exergaming 1.05 +/- 0.19

Adverse events

Time frame: 6 months

Arm	Deaths	Serious adverse events	Other adverse events
Exergaming	0/12 (0.0%)	0/12 (0.0%)	0/12 (0.0%)

+Locations (1)

Facility	City	Country	Status
University of Alabama at Birmingham	Birmingham, Alabama	United States

+Study documents

Study Protocol (PDF, 2019-06-24)

+Investigators

David Brown, PT, PhD, Principal investigator, University of Alabama at Birmingham

My Notes

Public

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