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

Cerebral Palsy Clinical Trial

Official title:

Learning Early Travel Skills: Effects of Power Mobility on the Development of Young Children With Severe Motor Impairments

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01115998
• Other study ID #: 07956
• Secondary ID: USDE #R305T01075
• Status: Completed
• Phase: Phase 2
• First received: March 19, 2009
• Last updated: May 20, 2010
• Start date: June 2002
• Est. completion date: December 2004

Study information

• Verified date: May 2010
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

More extensive description is not desired.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 2004
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Months to 30 Months

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy
• Child, Preschool

Intervention

Other:
• Power wheelchair
Children used power wheelchairs for one year. They continued to receive their usual early intervention services.
• No power wheelchairs
Children in the control group did not use power wheelchairs. They continued to receive their usual early intervention services.

Locations

Country	Name	City	State
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
University of Oklahoma	U.S. Department of Education

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline and 12 months	No
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.	Baseline and 12 months	No
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.	Baseline and 12 months	No