Effects of Power Mobility on Young Children With Severe Motor Impairments

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Other: Power mobility


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Months
Maximum Age: 30 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Power mobility<br>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. | Other: Power mobility<br>* 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.<br>|
| No Intervention: Control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Merrill-Palmer-Revised |  | Entry, 6-months, and 12-months | 
| Pediatric Evaluation of Disability Inventory |  | Entry, 6-months, 12-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child Health Status |  | Entry | 
| Two-position object permanence test |  | Entry, 6 months, 12 months | 
| Nonspeech Test |  | Entry, 6 month, 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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power wheelchairs, power mobility, young children