Cerebral Palsy Clinical Trial
Official title:
Hypertonia in Patients With Cerebral Palsy
NCT number | NCT00123708 |
Other study ID # | 050204 |
Secondary ID | 05-CH-0204 |
Status | Completed |
Phase | N/A |
First received | July 23, 2005 |
Last updated | June 30, 2017 |
Start date | July 19, 2005 |
Verified date | November 13, 2009 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study will classify types of hypertonia in patients with cerebral palsy and determine if
the classifications are reasonable in relation to the functional task of walking. Hypertonia
is an abnormal increase in muscle tension. It is a common symptom of cerebral palsy that can
lead to loss of function and deformity. This study may help scientists improve evaluation
criteria for hypertonia and, ultimately, treatment results.
Patients with cerebral palsy who are older than 6 years of age may be eligible for this
study. Candidates are screened with a medical history and clinical evaluation.
Participants are asked to walk in the lab while cameras record their movement. During this
test, subjects wear a t-shirt and shorts with their arms and legs wrapped with a soft,
rubber-like material. A piece of firm material is attached to the rubber sleeves and small
plastic reflective balls are attached to the firm material. Balls may also be attached to the
skin, using an adhesive. With the balls in place, the subject walks several times while
cameras record the positions of the balls. In addition, small metal electrodes attached to
the skin with an adhesive measure the electrical activity in the muscles.
After the walking test is completed, subjects' leg muscle strength is measured with a special
device while they perform three activities. First, they sit on a special chair with their leg
and foot placed in an apparatus that measures their strength, then lie on their back, then on
their stomach, and then stand on one foot holding a bar to balance during part of one
activity. During the activities, their reflexes are tested, they are asked to move their
legs, and their legs are moved for them.
Status | Completed |
Enrollment | 100 |
Est. completion date | |
Est. primary completion date | November 13, 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Years and older |
Eligibility |
- INCLUSION CRITERIA: This study will include children and adult patients with cerebral palsy, patients with dystonia, and able-bodied children older than 6 years of age. Each patient must meet the following criteria: The patient must have a diagnosis of cerebral palsy or dystonia The patient must be able to follow the instructions to successfully complete the testing The patient must be properly motivated and willing to do the tasks. The patient must be older than 6 years The patient must score a 2 or 3 on the walking subsection of the Gross Motor Function Classification System (GMFCS). The patient must cease taking medications known to affect spasticity at least 48 hours before the first investigation; however, if any antispasticity medication is longstanding and stable it should be maintained during the entire study. EXCLUSION CRITERIA: Inability of the patient to follow the instructions to accomplish the task. Structural deformities at the level of a knee joint. If patients are unable to complete all the tasks or conditions they can still be enrolled to complete part of the study. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
ASHWORTH B. PRELIMINARY TRIAL OF CARISOPRODOL IN MULTIPLE SCLEROSIS. Practitioner. 1964 Apr;192:540-2. — View Citation
Barry MJ, VanSwearingen JM, Albright AL. Reliability and responsiveness of the Barry-Albright Dystonia Scale. Dev Med Child Neurol. 1999 Jun;41(6):404-11. — View Citation
Blackburn M, van Vliet P, Mockett SP. Reliability of measurements obtained with the modified Ashworth scale in the lower extremities of people with stroke. Phys Ther. 2002 Jan;82(1):25-34. — View Citation
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