Effect of Power Wheelchairs on the Development and Function of Young Children With Severe Physical Disabilities

Phase 2

Completed

• Conditions: Child, Preschool; Cerebral Palsy
• Interventions: Other: Power wheelchair; Other: No power wheelchairs

• Registration Number: NCT01115998
• Lead Sponsor: University of Oklahoma

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.

Study Timeline

• Study Start: 2002-06
• Primary Completion: 2004-12
• Study Completion: 2004-12
• Study First Submitted: 2009-03-19
• Results First Submitted: 2009-03-19
• Study First Submitted QC: 2010-05-03
• Results First Submitted QC: 2010-05-03
• Study First Posted: 2010-05-04
• Results First Posted: 2010-05-04
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Power wheelchair	Power wheelchair	-
Control group	No power wheelchairs	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States