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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
  Purpose

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 Intervention Phase
Cerebral Palsy
Arthrogryposis
Spinal Muscular Atrophy
Other Central Nervous System or Musculoskeletal Disorders
 Other: Power mobility
Other: No intervention
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Learning Early Travel Skills: Effects of Power Mobility on the Development and Function of Young Children With Severe Motor Impairments

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: January 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Power mobility 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 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.

  Eligibility

Ages Eligible for Study:   14 Months to 30 Months
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT01028833     History of Changes
Other Study ID Numbers: H327A080006
Study First Received: December 7, 2009
Last Updated: February 6, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 16, 2013