Phase 2
N=34
Effect of Power Wheelchairs on the Development and Function of Young Children With Severe Physical Disabilities
Cerebral Palsy · Child, Preschool
Bottom Line
View on ClinicalTrials.gov: NCT01115998 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
May 2010
Primary outcome: Primary: Pediatric Evaluation of Disability Inventory — 14.6; 6.4; 8.0; 7.9 Units on scale — p=0.02
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Power wheelchair (Other); No power wheelchairs (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of Oklahoma
- Primary completion
- Dec 2004
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pediatric Evaluation of Disability Inventory |
14.6; 6.4; 8.0; 7.9; 4.7; 3.0 | 0.02 sig |
| PRIMARY Battelle Developmental Inventory (BDI) |
4.0; 3.0; 4.0; 5.0; 7.0; 3.0 | 0.92 |
| PRIMARY Early Coping Inventory |
6.0; 2.0; 7.0; 7.0 | >0.10 |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01115998). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.