- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01028833
Effects of Power Mobility on Young Children With Severe Motor Impairments
January 13, 2016 updated by: University of Oklahoma
Effects of Power Mobility on the Development and Function of Young Children With Severe Motor Impairments
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
41
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73117
- Department of Rehabilitation Sciences, Lee Mitchener Tolbert Center for Develompental Disabilities
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 2 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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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.
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No Intervention: 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Merrill-Palmer-Revised
Time Frame: Entry, 6-months, and 12-months
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Entry, 6-months, and 12-months
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Pediatric Evaluation of Disability Inventory
Time Frame: Entry, 6-months, 12-months
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Entry, 6-months, 12-months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Child Health Status
Time Frame: Entry
|
Entry
|
Two-position object permanence test
Time Frame: Entry, 6 months, 12 months
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Entry, 6 months, 12 months
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Nonspeech Test
Time Frame: Entry, 6 month, 12 months
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Entry, 6 month, 12 months
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Home Observation Measure of the Environment
Time Frame: Entry, 6 months, 12 months
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Entry, 6 months, 12 months
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Parenting Stress Inventory
Time Frame: Entry, 6 months, 12 months
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Entry, 6 months, 12 months
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Center for Epidemiologic Studies Depression Scale (CES-D)
Time Frame: Entry, 6 months, 12 months
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Entry, 6 months, 12 months
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Hollingshead Scale
Time Frame: Entry
|
Entry
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Maria A. Jones, PT, PhD, University of Oklahoma
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2008
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
December 7, 2009
First Submitted That Met QC Criteria
December 8, 2009
First Posted (Estimate)
December 9, 2009
Study Record Updates
Last Update Posted (Estimate)
January 14, 2016
Last Update Submitted That Met QC Criteria
January 13, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Congenital Abnormalities
- Brain Damage, Chronic
- Joint Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Neurodegenerative Diseases
- Neuromuscular Manifestations
- Pathological Conditions, Anatomical
- Spinal Cord Diseases
- Atrophy
- Musculoskeletal Abnormalities
- Motor Neuron Disease
- Cerebral Palsy
- Muscular Atrophy
- Musculoskeletal Diseases
- Muscular Atrophy, Spinal
- Arthrogryposis
Other Study ID Numbers
- 2480
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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