Effects of Dynamic Wheelchair Seating on Spasticity and Functional Mobility in Children

NCT ID: NCT00306761

Last Updated: 2014-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2007-08-31

Brief Summary

Cerebral palsy (CP) is a non-degenerative neuromuscular disease that can exist at or occur as a result of birth. Because of damage to one or more parts of the brain that control movement, an affected child cannot control his or her muscles normally. Prevalence of CP is similar worldwide, with pronounced severity in underdeveloped countries due to poor health and financial conditions.

Research should be conducted to find methods of medical treatment to allow affected children to maintain or regain musculoskeletal functionality. Many children affected with CP spend much of their days restricted to a rigid wheelchair; limiting muscular and cognitive development, making it difficult to interact with their environment. The gap to be addressed by this study is to determine if a wheelchair that is based on the dynamics of human anatomy can allow enhanced function, while being adaptive to individual growth and development. At present, there is very little dynamic capability available in commercial wheelchairs to allow this mobility.

A dynamic wheelchair system was recently designed and a small sample of able-bodied children has been tested in the chair. It is hypothesized that significant increases in functional mobility will be achieved in children with CP from the use of this novel wheelchair design.

Detailed Description

Specifically, it is expected that range of motion and functional mobility in the hip, knee, and ankle joints will increase, involuntary spasticity in the musculature of the mid and lower body will be reduced, and independent daily function will be enhanced in children with CP. The success of these conditions will greatly influence the child's interaction with the surrounding environment, maintaining neuromuscular function and providing enhanced mobility for coordinated development through childhood.

This research will bring great benefits for children with CP, however children with other neuromuscular conditions should also benefit from the findings of this initial study. Specifically, the direct health benefits will include increased joint range of motion, reduction of spasticity, enhanced cognitive development and muscle coordination. The concept of this novel wheelchair design could be applied domestically within one year of project completion. If funded, this initial study will lead to a subsequent project of two years, which would focus on the feasibility of broadening the target population to include children in under-represented areas within the United States and in developing countries.

Twenty children (4-12 years) with CP will be recruited for this study from the surrounding community and greater Rocky Mountain region. The study volunteers will be randomly assigned to either an experimental group (using new dynamic seating system), or a control group (using standard, state of the art non-dynamic chair systems). Consent will be obtained from each child and their parents/guardians. The study will consist of a pre-chair laboratory session, a supervised chair adaptation period (including a mid-way laboratory session) and a follow-up laboratory session. The pre-chair, mid-way and follow up laboratory sessions will consist of a series of cognitive/communicative, fine motor, and functional skill tests. Evaluation of these tests will be conducted by physical, occupational, and speech therapists. The wheelchair effect will be tested for significant improvement in joint range of motion, muscle spasticity and tone, and independent functionality.

Conditions

Cerebral Palsy, Spastic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Dynamic Wheelchair Seating System

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Spastic Cerebral Palsy
• Requires Wheelchair for mobility

Exclusion Criteria

• Unable to respond to clinical evaluation commands

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thrasher Research Fund

OTHER

Sponsor Role: collaborator

Montana State University

OTHER

Sponsor Role: lead

Responsible Party

Michael E. Hahn

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael E. Hahn, PhD

Role: PRINCIPAL_INVESTIGATOR

Montana State University

Locations

Epicenter Therapy Services

Bozeman, Montana, United States

Countries

United States

Other Identifiers

MSU_Thrasher

Identifier Type: -

Identifier Source: org_study_id