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| ID | Type | Description | Link |
|---|---|---|---|
| USDE #R305T010757 | Other Grant/Funding Number | U.S. Department of Education |
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| Name | Class |
|---|---|
| U.S. Department of Education | FED |
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Self-produced locomotion often is limited in children with cerebral palsy and other conditions that cause severe motor impairments. As a result, these children may be at risk for secondary impairments in spatial cognition, communication, social development, and other domains influenced by independent mobility. To compensate, power mobility has increasingly been advocated for young children with severe motor impairments. The study hypotheses were:
More extensive description is not desired.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Power wheelchair | Experimental |
| |
| Control group | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Power wheelchair | Other | Children used power wheelchairs for one year. They continued to receive their usual early intervention services. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pediatric Evaluation of Disability Inventory | Items measure mobility, self-care, and social function using a 2-point scale (0 = unable or limited ability; 1 = capable in most situations). Items measure caregiver assistance on a 6-point scale (0 = total assistance; 5 = independent). We used the change in scaled scores in each area and total scores for analyses. Worst possible scaled score is 0 and the best possible score is 100. | Baseline and 12 months |
| Battelle Developmental Inventory (BDI) | Items measure adaptive, cognitive, communication, motor, and personal-social development using 3-point ordinal scales (0 = does not complete; 1 = partially completes; 2 = completes item). We used change in age equivalent scores for each area and the total scores for analyses. The worst possible scores are 0 months age equivalent and the best possible scores are 95 months age equivalent. | Baseline and 12 months |
| Early Coping Inventory | We used the reactive and self-initiated behavior scales. We used change in raw scores for analyses. The worst possible raw score for each scale is 16 and the best possible score is 80. | Baseline and 12 months |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Irene R McEwen, PT, PhD | University of Oklahoma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 78104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28688787 | Derived | Mockler SR, McEwen IR, Jones MA. Retrospective Analysis of Predictors of Proficient Power Mobility in Young Children With Severe Motor Impairments. Arch Phys Med Rehabil. 2017 Oct;98(10):2034-2041. doi: 10.1016/j.apmr.2017.05.028. Epub 2017 Jul 5. |
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We used a matched pairs design and did not find matches for some of the children before they became too old for the study.
Children were recruited from throughout Oklahoma between February 2002 and December 2003. They were recruited through the statewide early intervention program, parent groups, radio, and contacts with occupational and physical therapists.
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| ID | Title | Description |
|---|---|---|
| FG000 | Power Wheelchair | Children were provided custom-fitted Invacare Power Tiger power wheelchairs to use in their homes and communities for 12 months. Parents were primarily responsible for providing practice opportunities and instruction, with the children's early intervention therapists and research staff helping to solve any problems. Parents were asked to: (1) provide the child with daily opportunities to sit in the device with the motor turned on during play; (2) encourage the child to experiment with movement in a relatively large space and not be concerned if the child drove in circles; and (3) avoid telling the child what to do, but rather to let the child ex experiment unless frustrated or unsafe. The importance of parental supervision, as one would supervise any young child, was stressed. The children also received their usual early intervention services, as specified on their individualized family service plans. |
| FG001 | Control Group | The control group did not receive power wheelchairs. They did receive early intervention services as specified on their individualized family service plans. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Power Wheelchair | |
| BG001 | Control Group | Children received usual early intervention services, but no power wheelchair. |
| BG002 |
| 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 | Pediatric Evaluation of Disability Inventory | Items measure mobility, self-care, and social function using a 2-point scale (0 = unable or limited ability; 1 = capable in most situations). Items measure caregiver assistance on a 6-point scale (0 = total assistance; 5 = independent). We used the change in scaled scores in each area and total scores for analyses. Worst possible scaled score is 0 and the best possible score is 100. | We did a per protocol analysis for 22 children who completed the study and an intention to treat (ITT) analysis for the 28 children for whom we had complete data at 12 months. The overall results of the ITT analysis did not differ from the per protocol analysis. | Posted | Median | Inter-Quartile Range | Units on scale | Baseline and 12 months |
|
One year
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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 | Power Wheelchair | Children were provided custom-fitted Invacare Power Tiger power wheelchairs to use in their homes and communities for 12 months. Parents were primarily responsible for providing practice opportunities and instruction, with the children's early intervention therapists and research staff helping to solve any problems. Parents were asked to: (1) provide the child with daily opportunities to sit in the device with the motor turned on during play; (2) encourage the child to experiment with movement in a relatively large space and not be concerned if the child drove in circles; and (3) avoid telling the child what to do, but rather to let the child ex experiment unless frustrated or unsafe. The importance of parental supervision, as one would supervise any young child, was stressed. The children also received their usual early intervention services, as specified on their individualized family service plans. |
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Small sample limited power; matched pairs design limited sample size and analyses; not all children were independent using power wheelchair in 1 year; cognitive measure probably unresponsive to changes in children with physical limitations.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Sponsored Programs | University of Oklahoma Health Sciences Cetner | 405-271--2090 | mary-cotter@ouhsc.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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| No power wheelchairs | Other | Children in the control group did not use power wheelchairs. They continued to receive their usual early intervention services. |
|
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Control Group | The control group did not receive power wheelchairs. They did receive early intervention services as specified on their individualized family service plans. |
|
|
|
| Primary | Battelle Developmental Inventory (BDI) | Items measure adaptive, cognitive, communication, motor, and personal-social development using 3-point ordinal scales (0 = does not complete; 1 = partially completes; 2 = completes item). We used change in age equivalent scores for each area and the total scores for analyses. The worst possible scores are 0 months age equivalent and the best possible scores are 95 months age equivalent. | We did a per protocol analysis for 22 children who completed the study and an intention to treat (ITT) analysis for the 28 children for whom we had complete data at 12 months. The overall results of the ITT analysis did not differ from the per protocol analysis. | Posted | Median | Inter-Quartile Range | Units on scale | Baseline and 12 months |
|
|
|
|
| Primary | Early Coping Inventory | We used the reactive and self-initiated behavior scales. We used change in raw scores for analyses. The worst possible raw score for each scale is 16 and the best possible score is 80. | We did a per protocol analysis for 22 children who completed the study and an intention to treat (ITT) analysis for the 28 children for whom we had complete data at 12 months. The overall results of the ITT analysis did not differ from the per protocol analysis. | Posted | Median | Inter-Quartile Range | Units on scale | Baseline and 12 months |
|
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Control Group | The control group did not receive power wheelchairs. They did receive early intervention services as specified on their individualized family service plans. | 0 | 17 | 0 | 17 |
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| Communication total |
|
| Motor total |
|
| Personal-social total |
|
| BDI total score |
|
Cognitive total Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months. |
| Wilcoxon Signed-Rank Test |
| 0.38 |
The a priori alpha level was <0.10 and it was not adjusted for multiple comparisons. |
| No |
| Superiority or Other |
| Communication total Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months. | Wilcoxon Signed-Rank Test | 0.42 | The a priori alpha level was <0.10 and it was not adjusted for multiple comparisons. | 90 | No | Superiority or Other |
| Motor total Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months. | Wilcoxon Signed-Rank Test | 0.57 | The a priori alpha level was <0.10 and it was not adjusted for multiple comparisons. | No | Superiority or Other |
| Personal-social total Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months. | Wilcoxon Signed-Rank Test | 0.69 | The a priori alpha level was <0.10 and it was not adjusted for multiple comparisons. | No | Superiority or Other |
| BID total score Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months. | Wilcoxon Signed-Rank Test | 0.28 | The a priori alpha level was <0.10 and it was not adjusted for multiple comparisons. | No | Superiority or Other |
| Wilcoxon Signed-Rank Test |
| >0.10 |
| No |
| Superiority or Other |