Trial Outcomes & Findings for Mixed Reality Gaming for Chronic Low Back Pain (NCT NCT03603028)

NCT ID: NCT03603028

Last Updated: 2020-01-22

Results Overview

How far participants walk while playing the game as measured by a meter on the instrumented treadmill.

Recruitment status

COMPLETED

Study phase

Target enrollment

13 participants

Primary outcome timeframe

Day 1 through Day 3 of study

Results posted on

2020-01-22

Participant Flow

One individual was unable to participate in Days 2, 3, and followup of the protocol.

Participant milestones

Participant milestones
Measure	Exergaming Exergaming: Mixed Reality Gaming for Chronic Low Back Pain
Overall Study STARTED	13
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Exergaming Exergaming: Mixed Reality Gaming for Chronic Low Back Pain
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Mixed Reality Gaming for Chronic Low Back Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Exergaming n=13 Participants Exergaming: Mixed Reality Gaming for Chronic Low Back Pain
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	53.9 years STANDARD_DEVIATION 5.1 • n=93 Participants
Sex: Female, Male Female	8 Participants n=93 Participants
Sex: Female, Male Male	5 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	13 Participants n=93 Participants
Race (NIH/OMB) White	0 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	13 participants n=93 Participants

PRIMARY outcome

Timeframe: Day 1 through Day 3 of study

Population: One participant withdrew from the study

How far participants walk while playing the game as measured by a meter on the instrumented treadmill.

Outcome measures

Outcome measures
Measure	Exergaming n=12 Participants Exergaming: Mixed Reality Gaming for Chronic Low Back Pain
Walking Distance	1,134.24 meters Standard Deviation 200.14

SECONDARY outcome

Timeframe: Day 1 - Day 3 of study

Population: One participant withdrew from the study

How fast participants walk while playing the game by dividing the distance people walked by the amount of time that they walked

Outcome measures

Outcome measures
Measure	Exergaming n=12 Participants Exergaming: Mixed Reality Gaming for Chronic Low Back Pain
Walking Speed	1.05 meters per second Standard Deviation 0.19

Adverse Events

Exergaming

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David A. Brown

UAB

Phone: 205-975-2788

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place