Effects of Power Mobility on Young Children With Severe Motor Impairments

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01028833
• Other study ID #: 2480
• Status: Completed
• Phase: Phase 2
• First received: December 7, 2009
• Last updated: January 13, 2016
• Start date: November 2008
• Est. completion date: December 2012

Study information

• Verified date: January 2016
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Months to 30 Months

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthrogryposis
• Cerebral Palsy
• Muscular Atrophy
• Muscular Atrophy, Spinal
• Musculoskeletal Diseases
• Other Central Nervous System or Musculoskeletal Disorders
• Spinal Muscular Atrophy

Intervention

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.

Locations

Country	Name	City	State
United States	Department of Rehabilitation Sciences, Lee Mitchener Tolbert Center for Develompental Disabilities	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Merrill-Palmer-Revised		Entry, 6-months, and 12-months	No
Primary	Pediatric Evaluation of Disability Inventory		Entry, 6-months, 12-months	No
Secondary	Child Health Status		Entry	No
Secondary	Two-position object permanence test		Entry, 6 months, 12 months	No
Secondary	Nonspeech Test		Entry, 6 month, 12 months	No
Secondary	Home Observation Measure of the Environment		Entry, 6 months, 12 months	No
Secondary	Parenting Stress Inventory		Entry, 6 months, 12 months	No
Secondary	Center for Epidemiologic Studies Depression Scale (CES-D)		Entry, 6 months, 12 months	No
Secondary	Hollingshead Scale		Entry	No