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

This study has been completed.
Sponsor:
Collaborator:
U.S. Department of Education
Information provided by:
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT01115998
First received: March 19, 2009
Last updated: May 20, 2010
Last verified: May 2010
  Purpose

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.

Condition Intervention Phase
Cerebral Palsy
Child, Preschool
Other: Power wheelchair
Other: No power wheelchairs
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Learning Early Travel Skills: Effects of Power Mobility on the Development of Young Children With Severe Motor Impairments

Resource links provided by NLM:


Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • Pediatric Evaluation of Disability Inventory [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 34
Study Start Date: June 2002
Study Completion Date: December 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
No Intervention: Control group Other: No power wheelchairs
Children in the control group did not use power wheelchairs. They continued to receive their usual early intervention services.

Detailed Description:

More extensive description is not desired.

  Eligibility

Ages Eligible for Study:   14 Months to 30 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01115998

Locations
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 78104
Sponsors and Collaborators
University of Oklahoma
U.S. Department of Education
Investigators
Principal Investigator: Irene R McEwen, PT, PhD University of Oklahoma
  More Information

No publications provided

Responsible Party: Irene McEwen, Principal Investigator, University of Oklahoma Health Sciences Center
ClinicalTrials.gov Identifier: NCT01115998     History of Changes
Other Study ID Numbers: 07956, USDE #R305T010757
Study First Received: March 19, 2009
Results First Received: March 19, 2009
Last Updated: May 20, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Oklahoma:
cerebral palsy
wheelchair
disabled children

Additional relevant MeSH terms:
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 30, 2014