Effects of Power Mobility on Young Children With Severe Motor Impairments

NCT ID: NCT01028833

Last Updated: 2016-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2012-12-31

Brief Summary

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The purpose this study is to determine the effects of power mobility on the development and function of young children of young children whose severe physical disabilities limit their exploratory behaviors and may unnecessarily restrict their cognitive, communication, and social-emotional development.

Detailed Description

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Conditions

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Cerebral Palsy Arthrogryposis Spinal Muscular Atrophy Other Central Nervous System or Musculoskeletal Disorders

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 mobility

Intervention included provision of power wheelchair and power mobility training program. Project staff will use structured power mobility training program to teach the children to use the power mobility devices. Project staff will schedule 1-hour sessions with each family 3 times per week for the first month of the project and will decrease in the following manner as the child becomes proficient and develops basic wheelchair maneuvering skills: two one-hour session per week for 4 weeks; one one-hour session per week for 4 weeks; two one-hour sessions per month for 4 weeks; one one-hour session per month for the remainder of the study.

Group Type EXPERIMENTAL

Power mobility

Intervention Type OTHER

Project staff will use structured power mobility training program to teach the children to use the power mobility devices. Project staff will schedule 1-hour sessions with each family 3 times per week for the first month of the project and will decrease in the following manner as the child becomes proficient and develops basic wheelchair maneuvering skills: two one-hour session per week for 4 weeks; one one-hour session per week for 4 weeks; two one-hour sessions per month for 4 weeks; one one-hour session per month for the remainder of the study.

Control

Children in the control group will not receive any additional intervention, but will continue to receive the early intervention or other services they were receiving prior to enrollment in this study.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Power mobility

Project staff will use structured power mobility training program to teach the children to use the power mobility devices. Project staff will schedule 1-hour sessions with each family 3 times per week for the first month of the project and will decrease in the following manner as the child becomes proficient and develops basic wheelchair maneuvering skills: two one-hour session per week for 4 weeks; one one-hour session per week for 4 weeks; two one-hour sessions per month for 4 weeks; one one-hour session per month for the remainder of the study.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Must be between 14- and 30-months of age
* Must have clinical diagnosis of a motor impairment that prevents functional independent mobility
* Must have adequate vision and hearing to use power mobility device safely
* Must have cognitive abilities 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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University of Oklahoma

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maria A. Jones, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

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Department of Rehabilitation Sciences, Lee Mitchener Tolbert Center for Develompental Disabilities

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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2480

Identifier Type: -

Identifier Source: org_study_id

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