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Inclusion Criteria: children ages 2 to 14 years with poor head control and non progressive diagnoses. Exclusion criteria: significant change of status i.e. prolonged hospitalization, surgery; inability to tolerate using Headpod. Requires use of Headpod 3x per day for minimum of 15 minutes each time over a 6 month period. Log must be kept documenting usage of the Headpod. Video will be taken to document changes.
Requires usage of the Headpod 3x per day for a minimum of 15 minutes each time. Usage required for 6 month period. Log must be kept documenting usage of the Headpod. Video will be taken on initial trial use, 1 week post trial use, at 3 months post utilization of the Headpod and at 6 months post utilization of the Headpod.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Headed utilization | Experimental | Use of Headpod for 6 months duration; 3 x per day for a minimum of 15 minutes each time; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Headpod | Device | Adaptive equipment to assist with active head movements |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Head Holding Active Time From Baseline to 6 Months | Active time in seconds holding head upright | baseline to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julie E Brown, DPT | Texas Woman's University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TWU School of Physical Therapy | Dallas | Texas | 75235 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Headpod Utilization | Use of Headpod for 6 months duration; 3 x per day for a minimum of 15 minutes each time. Three measurements were taken: Prior to Headpod use, after 3 months of Headpod use and, after 6 months of Headpod use. Headpod: Adaptive equipment to assist with active head movements |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Headpod Utilization | Use of Headpod for 6 months duration; 3 x per day for a minimum of 15 minutes each time; Headpod: Adaptive equipment to assist with active head movements |
| 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 | Change in Head Holding Active Time From Baseline to 6 Months | Active time in seconds holding head upright | Children ages 3 to 11 years | Posted | Mean | Standard Deviation | Seconds | baseline to 6 months |
|
|
1 year, 6 months
All cause mortality: One child unexpectedly died 2 months into the study. The death was unrelated to Headpod use.
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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 | Headed Utilization | Use of Headpod for 6 months duration; 3 x per day for a minimum of 15 minutes each time; Headpod: Adaptive equipment to assist with active head movements |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death unrelated to participation in study | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Julie Brown | Fort Worth Independent School district | 214-725-8232 | jbrown18@twu.edu |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Quasi-experimental, one-way repeated measures design
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| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| Active head time | Amount of time in seconds the child was able to hold the head upright against gravity. | Mean | Standard Deviation | seconds |
|
|
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| 1 |
| 14 |
| 1 |
| 14 |
| 0 |
| 14 |
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