Protocol Number: 05-CH-0204

Title:

Hypertonia in Patients with Cerebral Palsy

Number:

05-CH-0204

Summary:

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.

Sponsoring Institute:

National Institute of Child Health and Human Development (NICHD)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria:

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.

Special Instructions:

Currently Not Provided

Keywords:

Spasticity

Dystonia

Movement Disorders

Walking

Muscle Weakness

Resistance

Gait

Recruitment Keyword(s):

Cerebral Palsy

CP

Spasticity

Movement Disorders

Condition(s):

Cerebral Palsy

Muscle Hypertonia

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Institute of Child Health and Human Development

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

ASHWORTH B.PRELIMINARY TRIAL OF CARISOPRODOL IN MULTIPLE SCLEROSIS.Practitioner. 1964 Apr;192:540-2. No abstract available.

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.

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.

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