Effects of Power Mobility on Young Children With Severe Motor Impairments

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

University of Oklahoma

ClinicalTrials.gov Identifier:

NCT01028833

First received: December 7, 2009

Last updated: February 6, 2012

Last verified: February 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

December 7, 2009

Last Updated Date

February 6, 2012

Start Date ^ICMJE

January 2009

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Merrill-Palmer-Revised [ Time Frame: Entry, 6-months, and 12-months ] [ Designated as safety issue: No ]
Pediatric Evaluation of Disability Inventory [ Time Frame: Entry, 6-months, 12-months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01028833 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Child Health Status [ Time Frame: Entry ] [ Designated as safety issue: No ]
Two-position object permanence test [ Time Frame: Entry, 6 months, 12 months ] [ Designated as safety issue: No ]
Nonspeech Test [ Time Frame: Entry, 6 month, 12 months ] [ Designated as safety issue: No ]
Home Observation Measure of the Environment [ Time Frame: Entry, 6 months, 12 months ] [ Designated as safety issue: No ]
Parenting Stress Inventory [ Time Frame: Entry, 6 months, 12 months ] [ Designated as safety issue: No ]
Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: Entry, 6 months, 12 months ] [ Designated as safety issue: No ]
Hollingshead Scale [ Time Frame: Entry ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Effects of Power Mobility on Young Children With Severe Motor Impairments

Official Title ^ICMJE

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

Brief Summary

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

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

Intervention ^ICMJE

Other: 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.
Other: No intervention
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.

Study Arm (s)

Experimental: Power mobility
Intervention: Other: Power mobility
No Intervention: Control
Intervention: Other: No intervention

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2012

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

14 Months to 30 Months

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01028833

Other Study ID Numbers ^ICMJE

H327A080006

Has Data Monitoring Committee

Responsible Party

University of Oklahoma

Study Sponsor ^ICMJE

University of Oklahoma

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Maria A. Jones, PT, PhD

University of Oklahoma

Information Provided By

University of Oklahoma

Verification Date

February 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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