Effects of Power Mobility on Young Children With Severe Motor Impairments

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT01028833
First received: December 7, 2009
Last updated: January 13, 2016
Last verified: January 2016

December 7, 2009
January 13, 2016
November 2008
December 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01028833 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Effects of Power Mobility on Young Children With Severe Motor Impairments
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Cerebral Palsy
  • Arthrogryposis
  • Spinal Muscular Atrophy
  • Other Central Nervous System or Musculoskeletal Disorders
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.
  • 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.
    Intervention: Other: Power mobility
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
14 Months to 30 Months   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01028833
2480
No
Not Provided
Not Provided
University of Oklahoma
University of Oklahoma
Not Provided
Principal Investigator: Maria A. Jones, PT, PhD University of Oklahoma
University of Oklahoma
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP