Effect of Power Wheelchairs on the Development and Function of Young Children With Severe Physical Disabilities
|ClinicalTrials.gov Identifier: NCT01115998|
Recruitment Status : Completed
First Posted : May 4, 2010
Results First Posted : May 4, 2010
Last Update Posted : December 5, 2016
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:
- 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.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Palsy Child, Preschool||Other: Power wheelchair Other: No power wheelchairs||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Learning Early Travel Skills: Effects of Power Mobility on the Development of Young Children With Severe Motor Impairments|
|Study Start Date :||June 2002|
|Actual Primary Completion Date :||December 2004|
|Actual Study Completion Date :||December 2004|
|Experimental: Power wheelchair||
Other: Power wheelchair
Children used power wheelchairs for one year. They continued to receive their usual early intervention services.
Other Name: Invacare Power Tiger wheelchairs
Other: No power wheelchairs
Children in the control group did not use power wheelchairs. They continued to receive their usual early intervention services.
- Pediatric Evaluation of Disability Inventory [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01115998
|United States, Oklahoma|
|University of Oklahoma Health Sciences Center|
|Oklahoma City, Oklahoma, United States, 78104|
|Principal Investigator:||Irene R McEwen, PT, PhD||University of Oklahoma|