Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00306761
Status:
COMPLETED
Last Update Posted:
2014-09-16
First Post:
2006-03-23
Brief Title:
Effects of Dynamic Wheelchair Seating on Spasticity and Functional Mobility in Children
Sponsor:
Montana State University
Organization:
Montana State University
Study Overview
Official Title:
Effects of Dynamic Wheelchair Seating on Spasticity and Functional Mobility in Children
Status:
COMPLETED
Status Verified Date:
2014-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 childs 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 parentsguardians 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 cognitivecommunicative 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
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 parentsguardians 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 cognitivecommunicative 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None