Recurrent Low Back Pain
Conditions
Keywords
Walking, Exercise, Exergaming
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.
Interventions
DEVICEExergaming
Mixed Reality Gaming for Chronic Low Back Pain
Sponsors
From The Future LLC
University of Alabama at Birmingham
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
History of chronic low back pain
Exclusion criteria
No major neurological, cardiac, pulmonary, or other orthopedic injuries
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Pre-assignment details
One individual was unable to participate in Days 2, 3, and followup of the protocol.
Participants by arm
| Arm | Count |
|---|---|
| Exergaming Exergaming: Mixed Reality Gaming for Chronic Low Back Pain | 13 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Exergaming |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Age, Continuous | 53.9 years STANDARD_DEVIATION 5.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 13 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Walking Distance
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
Population: One participant withdrew from the study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exergaming | Walking Distance | 1,134.24 meters | Standard Deviation 200.14 |
Secondary
Walking Speed
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
Population: One participant withdrew from the study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exergaming | Walking Speed | 1.05 meters per second | Standard Deviation 0.19 |