Hypertonia in Patients With Cerebral Palsy

NCT00123708 | Completed

• 2 other identifiers: 05020405-CH-0204
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebral Palsy; Muscle Hypertonia

Keywords

Spasticity; Dystonia; Movement Disorders; Walking; Muscle Weakness; Resistance; Gait; Cerebral Palsy; CP

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

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

  PMID: 14143329 BACKGROUND

• 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. doi: 10.1017/s0012162299000870.

  PMID: 10400175 BACKGROUND

• 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. doi: 10.1093/ptj/82.1.25.

  PMID: 11784275 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy; Muscle Hypertonia; Muscle Spasticity; Dystonia; Movement Disorders; Muscle Weakness

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Dyskinesias; Pathologic Processes

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: July 23, 2005
• First Posted: July 25, 2005
• Study Start: July 19, 2005
• Primary Completion: November 13, 2009
• Last Updated: July 2, 2017

Record last verified: 2009-11-13

Locations

US (1)