- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01115998
Effect of Power Wheelchairs on the Development and Function of Young Children With Severe Physical Disabilities
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:
- 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.
- 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
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 78104
- University of Oklahoma Health Sciences Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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Experimental: Power wheelchair
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Children used power wheelchairs for one year.
They continued to receive their usual early intervention services.
Other Names:
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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
Sponsor
Collaborators
Investigators
- Principal Investigator: Irene R McEwen, PT, PhD, University of Oklahoma
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
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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