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Effects of Power Mobility on Young Children With Severe Motor Impairments

Primary Purpose

Cerebral Palsy, Arthrogryposis, Spinal Muscular Atrophy

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Power mobility
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 power wheelchairs, power mobility, young children

Eligibility Criteria

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

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Power mobility

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Merrill-Palmer-Revised
Pediatric Evaluation of Disability Inventory

Secondary Outcome Measures

Child Health Status
Two-position object permanence test
Nonspeech Test
Home Observation Measure of the Environment
Parenting Stress Inventory
Center for Epidemiologic Studies Depression Scale (CES-D)
Hollingshead Scale

Full Information

First Posted
December 7, 2009
Last Updated
January 13, 2016
Sponsor
University of Oklahoma
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1. Study Identification

Unique Protocol Identification Number
NCT01028833
Brief Title
Effects of Power Mobility on Young Children With Severe Motor Impairments
Official Title
Effects of Power Mobility on the Development and Function of Young Children With Severe Motor Impairments
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Arthrogryposis, Spinal Muscular Atrophy, Other Central Nervous System or Musculoskeletal Disorders
Keywords
power wheelchairs, power mobility, young children

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Power mobility
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Power mobility
Intervention Description
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.
Primary Outcome Measure Information:
Title
Merrill-Palmer-Revised
Time Frame
Entry, 6-months, and 12-months
Title
Pediatric Evaluation of Disability Inventory
Time Frame
Entry, 6-months, 12-months
Secondary Outcome Measure Information:
Title
Child Health Status
Time Frame
Entry
Title
Two-position object permanence test
Time Frame
Entry, 6 months, 12 months
Title
Nonspeech Test
Time Frame
Entry, 6 month, 12 months
Title
Home Observation Measure of the Environment
Time Frame
Entry, 6 months, 12 months
Title
Parenting Stress Inventory
Time Frame
Entry, 6 months, 12 months
Title
Center for Epidemiologic Studies Depression Scale (CES-D)
Time Frame
Entry, 6 months, 12 months
Title
Hollingshead Scale
Time Frame
Entry

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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria A. Jones, PT, PhD
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Rehabilitation Sciences, Lee Mitchener Tolbert Center for Develompental Disabilities
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73117
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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Effects of Power Mobility on Young Children With Severe Motor Impairments

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