Effects of Power Mobility on Young Children With Severe Motor Impairments

NCT01028833 | Completed Phase 2

• 1 other identifier: 2480
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

power wheelchairs; power mobility; young children

Outcome Measures

Primary Outcomes (2)

• Merrill-Palmer-Revised

  Entry, 6-months, and 12-months

• Pediatric Evaluation of Disability Inventory

  Entry, 6-months, 12-months

Secondary Outcomes (7)

• 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

Study Arms (2)

Power mobility

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Power mobility OTHER

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.

Power mobility

Eligibility Criteria

• Age: 14 Months - 30 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

Department of Rehabilitation Sciences, Lee Mitchener Tolbert Center for Develompental Disabilities

Oklahoma City, Oklahoma, 73117, United States

Location

Related Publications (1)

• Mockler SR, McEwen IR, Jones MA. Retrospective Analysis of Predictors of Proficient Power Mobility in Young Children With Severe Motor Impairments. Arch Phys Med Rehabil. 2017 Oct;98(10):2034-2041. doi: 10.1016/j.apmr.2017.05.028. Epub 2017 Jul 5.

  PMID: 28688787 DERIVED

MeSH Terms

Conditions

Cerebral Palsy; Arthrogryposis; Muscular Atrophy, Spinal; Musculoskeletal Diseases

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Joint Diseases; Muscular Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Spinal Cord Diseases; Motor Neuron Disease; Neurodegenerative Diseases; Neuromuscular Diseases

Study Officials

• Maria A. Jones, PT, PhD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2009
• First Posted: December 9, 2009
• Study Start: November 1, 2008
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 14, 2016

Record last verified: 2016-01

Locations

US (1)