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Effects of Power Mobility on Young Children With Severe Motor Impairments

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ClinicalTrials.gov Identifier: NCT01028833
Recruitment Status : Completed
First Posted : December 9, 2009
Last Update Posted : January 14, 2016
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Arthrogryposis Spinal Muscular Atrophy Other Central Nervous System or Musculoskeletal Disorders Other: Power mobility Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Power Mobility on the Development and Function of Young Children With Severe Motor Impairments
Study Start Date : November 2008
Primary Completion Date : December 2012
Study Completion Date : December 2012


Arms and Interventions

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.
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.
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.


Outcome Measures

Primary Outcome Measures :
  1. Merrill-Palmer-Revised [ Time Frame: Entry, 6-months, and 12-months ]
  2. Pediatric Evaluation of Disability Inventory [ Time Frame: Entry, 6-months, 12-months ]

Secondary Outcome Measures :
  1. Child Health Status [ Time Frame: Entry ]
  2. Two-position object permanence test [ Time Frame: Entry, 6 months, 12 months ]
  3. Nonspeech Test [ Time Frame: Entry, 6 month, 12 months ]
  4. Home Observation Measure of the Environment [ Time Frame: Entry, 6 months, 12 months ]
  5. Parenting Stress Inventory [ Time Frame: Entry, 6 months, 12 months ]
  6. Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: Entry, 6 months, 12 months ]
  7. Hollingshead Scale [ Time Frame: Entry ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Months to 30 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01028833


Locations
United States, Oklahoma
Department of Rehabilitation Sciences, Lee Mitchener Tolbert Center for Develompental Disabilities
Oklahoma City, Oklahoma, United States, 73117
Sponsors and Collaborators
University of Oklahoma
Investigators
Principal Investigator: Maria A. Jones, PT, PhD University of Oklahoma
More Information

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT01028833     History of Changes
Other Study ID Numbers: 2480
First Posted: December 9, 2009    Key Record Dates
Last Update Posted: January 14, 2016
Last Verified: January 2016

Keywords provided by University of Oklahoma:
power wheelchairs
power mobility
young children

Additional relevant MeSH terms:
Arthrogryposis
Atrophy
Cerebral Palsy
Muscular Atrophy
Muscular Atrophy, Spinal
Musculoskeletal Diseases
Pathological Conditions, Anatomical
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms
Spinal Cord Diseases
Motor Neuron Disease
Neurodegenerative Diseases
Neuromuscular Diseases
Joint Diseases
Muscular Diseases
Musculoskeletal Abnormalities
Congenital Abnormalities