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Completed

NCT Number: NCT01028833

Effects of Power Mobility on 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.

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Key information

Conditions

Cerebral Palsy Arthrogryposis Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Joint Diseases Motor Neuron Disease Muscular Atrophy, Spinal Muscular Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Other Central Nervous System or Musculoskeletal Disorders Spinal Cord Diseases Spinal Muscular Atrophy

Age range

14 month–30 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Oklahoma City, Oklahoma, 73117, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Power mobility

Other

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Official study title

Effects of Power Mobility on the Development and Function of Young Children With Severe Motor Impairments

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Dec 9, 2009
Registry last updated
Jan 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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