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

Primary Purpose

Cerebral Palsy, Child, Preschool

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Power wheelchair
No power wheelchairs
Sponsored by
University of Oklahoma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring cerebral palsy, wheelchair, disabled children

Eligibility Criteria

14 Months - 30 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Oklahoma Health Sciences Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Power wheelchair

Control group

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 19, 2009
Last Updated
October 24, 2016
Sponsor
University of Oklahoma
Collaborators
U.S. Department of Education
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1. Study Identification

Unique Protocol Identification Number
NCT01115998
Brief Title
Effect of Power Wheelchairs on the Development and Function of Young Children With Severe Physical Disabilities
Official Title
Learning Early Travel Skills: Effects of Power Mobility on the Development of Young Children With Severe Motor Impairments
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
December 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oklahoma
Collaborators
U.S. Department of Education

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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.
Detailed Description
More extensive description is not desired.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Child, Preschool
Keywords
cerebral palsy, wheelchair, disabled children

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Power wheelchair
Arm Type
Experimental
Arm Title
Control group
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Power wheelchair
Other Intervention Name(s)
Invacare Power Tiger wheelchairs
Intervention Description
Children used power wheelchairs for one year. They continued to receive their usual early intervention services.
Intervention Type
Other
Intervention Name(s)
No power wheelchairs
Intervention Description
Children in the control group did not use power wheelchairs. They continued to receive their usual early intervention services.
Primary Outcome Measure Information:
Title
Pediatric Evaluation of Disability Inventory
Description
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.
Time Frame
Baseline and 12 months
Title
Battelle Developmental Inventory (BDI)
Description
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.
Time Frame
Baseline and 12 months
Title
Early Coping Inventory
Description
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.
Time Frame
Baseline and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Months
Maximum Age & Unit of Time
30 Months
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irene R McEwen, PT, PhD
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
78104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28688787
Citation
Mockler SR, McEwen IR, Jones MA. Retrospective Analysis of Predictors of Proficient Power Mobility in Young Children With Severe Motor Impairments. Arch Phys Med Rehabil. 2017 Oct;98(10):2034-2041. doi: 10.1016/j.apmr.2017.05.028. Epub 2017 Jul 5.
Results Reference
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Effect of Power Wheelchairs on the Development and Function of Young Children With Severe Physical Disabilities

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