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| ID | Type | Description | Link |
|---|---|---|---|
| P50MD017338 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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The purpose of this study is to work with a community engagement group to develop and pilot a protocol for a virtual reality exergaming program for children with special needs at a high school.
A virtual reality exercise program will be run during school special physical education hours at a public high school. The program will be implemented by a person with cerebral palsy. The exercise will include rhythmic movement to music and fitness games.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual reality exercise program in special physical education | Experimental | During normal special physical education hours, participants will be provided with a virtual reality headset and exercise games and be prescribed to exercise at a moderate intensity. |
|
| Virtual reality exercise program at home | Active Comparator | Participants will be provided with a virtual reality headset and exercise games and be prescribed to exercise at a moderate intensity at home. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual reality exercise | Behavioral | During school special physical education, participants will be asked to exercise using a virtual reality exercise headset, that will be adapted for arm use. Participants will asked to be seated during gameplay. Heart rate will be monitored and recorded during exercise. |
| Measure | Description | Time Frame |
|---|---|---|
| Attendance | The percentage of session attended over the 6 week duration. Values were found by taking the total number of session attended by each group, divided by the total number of session across 6 weeks. | Weeks 1 to 6 |
| Move Minutes | Average Move minutes obtained per week. Move minutes across the 6 week duration were summed and averaged per group at the given exercise perscription. | Weeks 1 to 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Walking Endurance | Distance (in meters) covered throughout a 6 minute walk. | Week 1 and Week 6 |
| Hand Grip Strength | Hand grip strength measured via a digital hand dynamometer |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Byron Lai, PhD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Alabama | Birmingham | Alabama | 35233 | United States |
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Participants self-selected their exercise setting. One participant signed a digital consent form and chose the school setting, but voluntary withdrew prior to the baseline data collection.
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| ID | Title | Description |
|---|---|---|
| FG000 | School Based | Participants were asked to exercise on site for 25 minutes 3 times a week during study hall for 6 weeks. |
| FG001 | Home Based | Participants were asked to exercise in their home for 25 minutes 3 times a week for 6 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | School Based | Participants were asked to exercise on site for 25 minutes 3 times a week during study hall for 6 weeks. |
| BG001 | Home Based | Participants were asked to exercise in their home for 25 minutes 3 times a week for 6 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Attendance | The percentage of session attended over the 6 week duration. Values were found by taking the total number of session attended by each group, divided by the total number of session across 6 weeks. | Posted | Number | percentage of total sessions attended | Weeks 1 to 6 |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Virtual Reality Exercise Program in Special Physical Education | During normal special physical education hours participants were provided with a virtual reality headset and exercise games. Over 6 weeks they were prescribed to exercise at a moderate intensity 3 times a week for 25 minutes, during their special physical education period. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Byron Lai, PhD | University of Alabama at Birmingham (UAB) | 205-638-9790 | 8-9725 | byronlai@uab.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 13, 2024 | Feb 21, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002658 | Developmental Disabilities |
| D057185 | Sedentary Behavior |
| ID | Term |
|---|---|
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000088544 | Exergaming |
| ID | Term |
|---|---|
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
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|
| Week 1 and Week 6 |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Primary Disability | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Move Minutes | Average Move minutes obtained per week. Move minutes across the 6 week duration were summed and averaged per group at the given exercise perscription. | Posted | Mean | Standard Deviation | Average Move Minutes per week | Weeks 1 to 6 |
|
|
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| Secondary | Walking Endurance | Distance (in meters) covered throughout a 6 minute walk. | Posted | Mean | Standard Deviation | Meters traveled in 6 minutes | Week 1 and Week 6 |
|
|
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| Secondary | Hand Grip Strength | Hand grip strength measured via a digital hand dynamometer | Posted | Mean | Standard Deviation | Average Kilograms | Week 1 and Week 6 |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Home-based Virtual Reality Exercise Program | Participants were provided with a virtual reality headset and exercise games. Over 6 weeks they were prescribed to exercise at a moderate intensity 3 times a week for 25 minutes at their homes. | 0 | 4 | 0 | 4 | 0 | 4 |
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| D055687 |
| Musculoskeletal and Neural Physiological Phenomena |
| Week 6 Left |
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| Week 6 Right |
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