Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| From The Future LLC | UNKNOWN |
Not provided
Not provided
Not provided
Mixed Reality Gaming for Chronic Low Back Pain
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exergaming | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exergaming | Device | Mixed Reality Gaming for Chronic Low Back Pain |
|
| Measure | Description | Time Frame |
|---|---|---|
| Walking Distance | How far participants walk while playing the game as measured by a meter on the instrumented treadmill. | Day 1 through Day 3 of study |
| Measure | Description | Time Frame |
|---|---|---|
| Walking Speed | 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 |
Not provided
Inclusion Criteria:
History of chronic low back pain
Exclusion Criteria:
No major neurological, cardiac, pulmonary, or other orthopedic injuries
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David Brown, PT, PhD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
One individual was unable to participate in Days 2, 3, and followup of the protocol.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Exergaming | Exergaming: Mixed Reality Gaming for Chronic Low Back Pain |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
One participant withdrew from the study
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Exergaming | Exergaming: Mixed Reality Gaming for Chronic Low Back Pain |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Walking Distance | How far participants walk while playing the game as measured by a meter on the instrumented treadmill. | One participant withdrew from the study | Posted | Mean | Standard Deviation | meters | Day 1 through Day 3 of study |
|
|
6 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exergaming | Exergaming: Mixed Reality Gaming for Chronic Low Back Pain | 0 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David A. Brown | UAB | 205-975-2788 | dbrownpt@uab.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 24, 2019 | Dec 4, 2019 | Prot_000.pdf |
Not provided
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Participants |
| No |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participants |
|
|
| 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 | One participant withdrew from the study | Posted | Mean | Standard Deviation | meters per second | Day 1 - Day 3 of study |
|
|
|
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
Not provided
Not provided
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |