Effects of Power Mobility on Young Children With Severe Motor Impairments

Phase 2

Completed

• Conditions: Other Central Nervous System or Musculoskeletal Disorders; Spinal Muscular Atrophy; Cerebral Palsy; Arthrogryposis
• Interventions: Other: Power mobility

• Registration Number: NCT01028833
• Lead Sponsor: University of Oklahoma

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2009-12-07
• Study First Submitted QC: 2009-12-08
• Study First Posted: 2009-12-09
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-13
• Last Update Posted: 2016-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Power mobility	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.

Primary Outcome Measures

Name	Time	Method
Merrill-Palmer-Revised	Entry, 6-months, and 12-months
Pediatric Evaluation of Disability Inventory	Entry, 6-months, 12-months

Secondary Outcome Measures

Name	Time	Method
Two-position object permanence test	Entry, 6 months, 12 months
Home Observation Measure of the Environment	Entry, 6 months, 12 months
Parenting Stress Inventory	Entry, 6 months, 12 months
Center for Epidemiologic Studies Depression Scale (CES-D)	Entry, 6 months, 12 months
Hollingshead Scale	Entry
Nonspeech Test	Entry, 6 month, 12 months
Child Health Status	Entry

Trial Locations

Locations (1)

Department of Rehabilitation Sciences, Lee Mitchener Tolbert Center for Develompental Disabilities; 🇺🇸 Oklahoma City, Oklahoma, United States