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

This study has been completed.
Sponsor:
Collaborator:
Thrasher Research Fund
Information provided by (Responsible Party):
Michael E. Hahn, Montana State University
ClinicalTrials.gov Identifier:
NCT00306761
First received: March 23, 2006
Last updated: September 15, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Cerebral Palsy, Spastic
Device: Dynamic Wheelchair Seating System

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Dynamic Wheelchair Seating on Spasticity and Functional Mobility in Children

Resource links provided by NLM:


Further study details as provided by Montana State University:

Primary Outcome Measures:
  • Joint range of motion
  • Muscle spasticity
  • Functional Capacity Assessments

Estimated Enrollment: 20
Study Start Date: April 2006
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   4 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Spastic Cerebral Palsy
  • Requires Wheelchair for mobility

Exclusion Criteria:

  • Unable to respond to clinical evaluation commands
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00306761

Locations
United States, Montana
Epicenter Therapy Services
Bozeman, Montana, United States, 59715
Sponsors and Collaborators
Montana State University
Thrasher Research Fund
Investigators
Principal Investigator: Michael E. Hahn, PhD Montana State University
  More Information

No publications provided

Responsible Party: Michael E. Hahn, Assistant Professor, Montana State University
ClinicalTrials.gov Identifier: NCT00306761     History of Changes
Other Study ID Numbers: MSU_Thrasher
Study First Received: March 23, 2006
Last Updated: September 15, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on November 20, 2014