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

October 24, 2016 updated by: Irene McEwen, University of Oklahoma

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

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.

Study Overview

Detailed Description

More extensive description is not desired.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 78104
        • University of Oklahoma Health Sciences Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control group
Children in the control group did not use power wheelchairs. They continued to receive their usual early intervention services.
Experimental: Power wheelchair
Children used power wheelchairs for one year. They continued to receive their usual early intervention services.
Other Names:
  • Invacare Power Tiger wheelchairs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 12 months
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.
Baseline and 12 months
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.
Baseline and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Irene R McEwen, PT, PhD, University of Oklahoma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2002

Primary Completion (Actual)

December 1, 2004

Study Completion (Actual)

December 1, 2004

Study Registration Dates

First Submitted

March 19, 2009

First Submitted That Met QC Criteria

May 3, 2010

First Posted (Estimate)

May 4, 2010

Study Record Updates

Last Update Posted (Estimate)

December 5, 2016

Last Update Submitted That Met QC Criteria

October 24, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 07956
  • USDE #R305T010757 (Other Grant/Funding Number: U.S. Department of Education)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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