Cerebral Palsy, Child, Preschool
Conditions
Keywords
cerebral palsy, wheelchair, disabled children
Brief summary
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: 1. Children with severe disabilities that prevent independent locomotion who learn to use power mobility devices when they are 14- to 30-months-of-age will have greater communication, social, and cognitive development over a 12-month period, and will demonstrate more competent coping skills than children with the same characteristics who do not use power mobility. 2. Parents of children who use power mobility will view it as a positive influence on their children's lives, and will perceive their children's development to be more mature than the parents of children who do not use power mobility will perceive their children's development.
Detailed description
More extensive description is not desired.
Interventions
OTHERPower wheelchair
Children used power wheelchairs for one year. They continued to receive their usual early intervention services.
OTHERNo power wheelchairs
Children in the control group did not use power wheelchairs. They continued to receive their usual early intervention services.
Sponsors
U.S. Department of Education
University of Oklahoma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
14 Months to 30 Months
Healthy volunteers
No
Inclusion criteria
* Age 14 to 30 months * Motor impairment that prevents functional independent mobility * Vision and hearing adequate to use a power mobility device safely. * Cognitive abilities assessed to be at least equivalent to a 12-month level or alertness and interest in the environment that suggests a trial of power mobility is warranted.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pediatric Evaluation of Disability Inventory | Baseline and 12 months | 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. |
| Battelle Developmental Inventory (BDI) | Baseline and 12 months | 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. |
| Early Coping Inventory | Baseline and 12 months | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
We used a matched pairs design and did not find matches for some of the children before they became too old for the study.
Participants by arm
| Arm | Count |
|---|---|
| Power Wheelchair | 17 |
| Control Group Children received usual early intervention services, but no power wheelchair. | 17 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 6 |
Baseline characteristics
| Characteristic | Control Group | Power Wheelchair | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 17 Participants | 17 Participants | 34 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 1.85 years STANDARD_DEVIATION 0.41 | 1.78 years STANDARD_DEVIATION 0.45 | 1.82 years STANDARD_DEVIATION 0.43 |
| Gender Female | 10 Participants | 9 Participants | 19 Participants |
| Gender Male | 7 Participants | 8 Participants | 15 Participants |
| Region of Enrollment United States | 17 participants | 17 participants | 34.0 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 17 | 0 / 17 |
| serious Total, serious adverse events | 0 / 17 | 0 / 17 |
Outcome results
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.
Time frame: Baseline and 12 months
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Power Wheelchair | Battelle Developmental Inventory (BDI) | Adaptive total | 4.0 Units on scale | Inter-Quartile Range 1.06 |
| Power Wheelchair | Battelle Developmental Inventory (BDI) | Cognitive total | 4.0 Units on scale | Inter-Quartile Range 1.51 |
| Power Wheelchair | Battelle Developmental Inventory (BDI) | Communication total | 7.0 Units on scale | Inter-Quartile Range 1.53 |
| Power Wheelchair | Battelle Developmental Inventory (BDI) | Motor total | 2.0 Units on scale | Inter-Quartile Range 0.52 |
| Power Wheelchair | Battelle Developmental Inventory (BDI) | Personal-social total | 5.0 Units on scale | Inter-Quartile Range 0.93 |
| Power Wheelchair | Battelle Developmental Inventory (BDI) | BDI total score | 6.0 Units on scale | Inter-Quartile Range 0.82 |
| Control Group | Battelle Developmental Inventory (BDI) | Personal-social total | 6.0 Units on scale | Inter-Quartile Range 1.18 |
| Control Group | Battelle Developmental Inventory (BDI) | Adaptive total | 3.0 Units on scale | Inter-Quartile Range 1.05 |
| Control Group | Battelle Developmental Inventory (BDI) | Motor total | 3.0 Units on scale | Inter-Quartile Range 0.5 |
| Control Group | Battelle Developmental Inventory (BDI) | Cognitive total | 5.0 Units on scale | Inter-Quartile Range 0.93 |
| Control Group | Battelle Developmental Inventory (BDI) | BDI total score | 4.0 Units on scale | Inter-Quartile Range 0.73 |
| Control Group | Battelle Developmental Inventory (BDI) | Communication total | 3.0 Units on scale | Inter-Quartile Range 0.98 |
Comparison: Adaptive total~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months.p-value: 0.92Wilcoxon Signed-Rank Test
Comparison: Cognitive total~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months.p-value: 0.38Wilcoxon Signed-Rank Test
Comparison: Communication total~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months.p-value: 0.42Wilcoxon Signed-Rank Test
Comparison: Motor total~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months.p-value: 0.57Wilcoxon Signed-Rank Test
Comparison: 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.p-value: 0.69Wilcoxon Signed-Rank Test
Comparison: 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.p-value: 0.28Wilcoxon Signed-Rank Test
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.
Time frame: Baseline and 12 months
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Power Wheelchair | Early Coping Inventory | Reactive Scale | 6.0 Units on scale |
| Power Wheelchair | Early Coping Inventory | Self Initiated Scale | 7.0 Units on scale |
| Control Group | Early Coping Inventory | Reactive Scale | 2.0 Units on scale |
| Control Group | Early Coping Inventory | Self Initiated Scale | 7.0 Units on scale |
Comparison: Reactive scale~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months.p-value: >0.1Wilcoxon Signed-Rank Test
Comparison: Self Initiated Scale~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months.p-value: >0.1Wilcoxon Signed-Rank Test
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.
Time frame: Baseline and 12 months
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Power Wheelchair | Pediatric Evaluation of Disability Inventory | Mobility functional skills | 14.6 Units on scale | Inter-Quartile Range 2.04 |
| Power Wheelchair | Pediatric Evaluation of Disability Inventory | Self-care functional skills | 8.0 Units on scale | Inter-Quartile Range 0.95 |
| Power Wheelchair | Pediatric Evaluation of Disability Inventory | Social function functional skills | 4.7 Units on scale | Inter-Quartile Range 1.25 |
| Power Wheelchair | Pediatric Evaluation of Disability Inventory | Mobility caregiver assistance | 29.2 Units on scale | Inter-Quartile Range 2.97 |
| Power Wheelchair | Pediatric Evaluation of Disability Inventory | Self-care caregiver assistance | 12.3 Units on scale | Inter-Quartile Range 3.6 |
| Power Wheelchair | Pediatric Evaluation of Disability Inventory | Social function caregiver assistance | 14.8 Units on scale | Inter-Quartile Range 3.36 |
| Control Group | Pediatric Evaluation of Disability Inventory | Self-care caregiver assistance | 5.8 Units on scale | Inter-Quartile Range 3.45 |
| Control Group | Pediatric Evaluation of Disability Inventory | Mobility functional skills | 6.4 Units on scale | Inter-Quartile Range 3.11 |
| Control Group | Pediatric Evaluation of Disability Inventory | Mobility caregiver assistance | 14.2 Units on scale | Inter-Quartile Range 4 |
| Control Group | Pediatric Evaluation of Disability Inventory | Self-care functional skills | 7.9 Units on scale | Inter-Quartile Range 1.68 |
| Control Group | Pediatric Evaluation of Disability Inventory | Social function caregiver assistance | 19.7 Units on scale | Inter-Quartile Range 3.96 |
| Control Group | Pediatric Evaluation of Disability Inventory | Social function functional skills | 3.0 Units on scale | Inter-Quartile Range 1.93 |
Comparison: Mobility functional skills~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months.p-value: 0.02Wilcoxon Signed-Rank Test
Comparison: Self-care functional skills~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months.p-value: 0.52Wilcoxon Signed-Rank Test
Comparison: Social function functional skills~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months.p-value: 0.38Wilcoxon Signed-Rank Test
Comparison: Mobility care giver assistance.~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months.p-value: 0.03Wilcoxon Signed-Rank Test
Comparison: Self-care caregiver assistance~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months.p-value: 0.006Wilcoxon Signed-Rank Test
Comparison: Social function caregiver assistance~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months.p-value: 0.45Wilcoxon Signed-Rank Test