Effects of Power Mobility on Young Children With Severe Motor Impairments

Sponsor

University of Oklahoma (Other)

Overall Status

Completed

CT.gov ID

NCT01028833

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Palsy Arthrogryposis Spinal Muscular Atrophy Other Central Nervous System or Musculoskeletal Disorders	Other: Power mobility	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

41 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2008

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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.	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.
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.

Arm

Intervention/Treatment

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.

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.

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.

Outcome Measures

Primary Outcome Measures

Merrill-Palmer-Revised [Entry, 6-months, and 12-months]
Pediatric Evaluation of Disability Inventory [Entry, 6-months, 12-months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Months to 30 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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