search
Back to results

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

Primary Purpose

Cerebral Palsy, Spastic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dynamic Wheelchair Seating System
Sponsored by
Montana State University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy, Spastic

Eligibility Criteria

4 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Spastic Cerebral Palsy Requires Wheelchair for mobility Exclusion Criteria: Unable to respond to clinical evaluation commands

Sites / Locations

  • Epicenter Therapy Services

Outcomes

Primary Outcome Measures

Joint range of motion
Muscle spasticity
Functional Capacity Assessments

Secondary Outcome Measures

Full Information

First Posted
March 23, 2006
Last Updated
September 15, 2014
Sponsor
Montana State University
Collaborators
Thrasher Research Fund
search

1. Study Identification

Unique Protocol Identification Number
NCT00306761
Brief Title
Effects of Dynamic Wheelchair Seating on Spasticity and Functional Mobility in Children
Official Title
Effects of Dynamic Wheelchair Seating on Spasticity and Functional Mobility in Children
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montana State University
Collaborators
Thrasher Research Fund

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Spastic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Dynamic Wheelchair Seating System
Primary Outcome Measure Information:
Title
Joint range of motion
Title
Muscle spasticity
Title
Functional Capacity Assessments

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Spastic Cerebral Palsy Requires Wheelchair for mobility Exclusion Criteria: Unable to respond to clinical evaluation commands
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael E. Hahn, PhD
Organizational Affiliation
Montana State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Epicenter Therapy Services
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59715
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs