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

NCT ID: NCT01115998

Last Updated: 2016-12-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2004-12-31

Brief Summary

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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.

Detailed Description

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More extensive description is not desired.

Conditions

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Cerebral Palsy Child, Preschool

Keywords

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cerebral palsy wheelchair disabled children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Power wheelchair

Group Type EXPERIMENTAL

Power wheelchair

Intervention Type OTHER

Children used power wheelchairs for one year. They continued to receive their usual early intervention services.

Control group

Group Type OTHER

No power wheelchairs

Intervention Type OTHER

Children in the control group did not use power wheelchairs. They continued to receive their usual early intervention services.

Interventions

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Power wheelchair

Children used power wheelchairs for one year. They continued to receive their usual early intervention services.

Intervention Type OTHER

No power wheelchairs

Children in the control group did not use power wheelchairs. They continued to receive their usual early intervention services.

Intervention Type OTHER

Other Intervention Names

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Invacare Power Tiger wheelchairs

Eligibility Criteria

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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.
Minimum Eligible Age

14 Months

Maximum Eligible Age

30 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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U.S. Department of Education

FED

Sponsor Role collaborator

University of Oklahoma

OTHER

Sponsor Role lead

Responsible Party

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Irene McEwen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Irene R McEwen, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

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University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 28688787 (View on PubMed)

Other Identifiers

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USDE #R305T010757

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

07956

Identifier Type: -

Identifier Source: org_study_id