Effect of Power Wheelchairs on the Development and Function of Young Children With Severe Physical Disabilities

NCT01115998 | Completed Phase 2 Results

• 2 other identifiers: 07956USDE #R305T010757
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Self-produced locomotion often is limited in children with cerebral palsy and other conditions that cause severe motor impairments. As a result, these children may be at risk for secondary impairments in spatial cognition, communication, social development, and other domains influenced by independent mobility. To compensate, power mobility has increasingly been advocated for young children with severe motor impairments. The study hypotheses were:

1. 1.Children with severe disabilities that prevent independent locomotion who learn to use power mobility devices when they are 14- to 30-months-of-age will have greater communication, social, and cognitive development over a 12-month period, and will demonstrate more competent coping skills than children with the same characteristics who do not use power mobility.
2. 2.Parents of children who use power mobility will view it as a positive influence on their children's lives, and will perceive their children's development to be more mature than the parents of children who do not use power mobility will perceive their children's development.

Conditions

Cerebral Palsy; Child, Preschool

Keywords

cerebral palsy; wheelchair; disabled children

Outcome Measures

Primary Outcomes (3)

• Pediatric Evaluation of Disability Inventory

  Items measure mobility, self-care, and social function using a 2-point scale (0 = unable or limited ability; 1 = capable in most situations). Items measure caregiver assistance on a 6-point scale (0 = total assistance; 5 = independent). We used the change in scaled scores in each area and total scores for analyses. Worst possible scaled score is 0 and the best possible score is 100.

  Baseline and 12 months

• Battelle Developmental Inventory (BDI)

  Items measure adaptive, cognitive, communication, motor, and personal-social development using 3-point ordinal scales (0 = does not complete; 1 = partially completes; 2 = completes item). We used change in age equivalent scores for each area and the total scores for analyses. The worst possible scores are 0 months age equivalent and the best possible scores are 95 months age equivalent.

  Baseline and 12 months

• Early Coping Inventory

  We used the reactive and self-initiated behavior scales. We used change in raw scores for analyses. The worst possible raw score for each scale is 16 and the best possible score is 80.

  Baseline and 12 months

Study Arms (2)

Power wheelchair

EXPERIMENTAL

Other: Power wheelchair

Control group

OTHER

Other: No power wheelchairs

Interventions

Power wheelchair OTHER

Children used power wheelchairs for one year. They continued to receive their usual early intervention services.

Also known as: Invacare Power Tiger wheelchairs

Power wheelchair

No power wheelchairs OTHER

Children in the control group did not use power wheelchairs. They continued to receive their usual early intervention services.

Control group

Eligibility Criteria

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

You may qualify if:

• Age 14 to 30 months
• Motor impairment that prevents functional independent mobility
• Vision and hearing adequate to use a power mobility device safely.
• Cognitive abilities assessed to be at least 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
• U.S. Department of Education: collaborator

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 78104, 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

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Limitations and Caveats

Small sample limited power; matched pairs design limited sample size and analyses; not all children were independent using power wheelchair in 1 year; cognitive measure probably unresponsive to changes in children with physical limitations.

Results Point of Contact

• Title: Director of Sponsored Programs
• Organization: University of Oklahoma Health Sciences Cetner

mary-cotter@ouhsc.edu

405-271--2090

Study Officials

• Irene R McEwen, PT, PhD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 19, 2009
• First Posted: May 4, 2010
• Study Start: June 1, 2002
• Primary Completion: December 1, 2004
• Study Completion: December 1, 2004
• Last Updated: December 5, 2016
• Results First Posted: May 4, 2010

Record last verified: 2016-10

Locations

US (1)