Cerebral Palsy, SpasticNCT00306761
Effects of Dynamic Wheelchair Seating on Spasticity and Functional Mobility in Children
A study testing Dynamic Wheelchair Seating System in people with Cerebral Palsy, Spastic, run by Montana State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Cerebral Palsy, Spastic
- What is being tested?
- Dynamic Wheelchair Seating System
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Aug 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Spastic Cerebral Palsy
- Requires Wheelchair for mobility
Who cannot join
- Unable to respond to clinical evaluation commands
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Dynamic Wheelchair Seating System
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Wheelchair Seating SystemDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Joint range of motion
Muscle spasticity
Functional Capacity Assessments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2006 (estimated)
- Study startApr 2006
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy, SpasticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montana State University
- Sponsor type
- University, hospital or other
- Collaborators
- Thrasher Research Fund
- Responsible party
- Principal investigator, Michael E. Hahn, Montana State University
- Investigators
- Michael E. Hahn, PhD, Principal investigator, Montana State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00306761
- Sponsor's protocol ID
- MSU_Thrasher
- Status last verified
- Sep 2014
- First submitted
- 23 Mar 2006
- Last updated
- 16 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dynamic Wheelchair Seating on Spasticity and Functional Mobility in Children
- ClinicalTrials.gov ID
- NCT00306761
- Acronym / sponsor ID
- MSU_Thrasher
- Conditions
- Cerebral Palsy, Spastic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Montana State UniversityUniversity, hospital or other
- Collaborators
- Thrasher Research Fund
- Study start
- Apr 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 24 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Spastic Cerebral Palsy
- Requires Wheelchair for mobility
Key exclusion criteria (1 listed)
- Unable to respond to clinical evaluation commands
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic Wheelchair Seating System | Device | – |
Primary outcome
Joint range of motion
Muscle spasticity
Functional Capacity Assessments
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2014.
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Peripheral Neurotomies of the Upper Limb in Children With Cerebral Palsy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael E. Hahn, PhD principal investigator
Montana State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic Wheelchair Seating System in people with Cerebral Palsy, Spastic, run by Montana State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Joint range of motion. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2014.