NIH Clinical Research Studies

Protocol Number: 04-N-0034

Active Accrual, Protocols Recruiting New Patients

Title:
Classification of Cerebral Palsy Subtypes
Number:
04-N-0034
Summary:
This study, conducted at the National Institutes of Health and the Children's National Medical Center, will evaluate how well different physicians agree in how they classify cerebral palsy subtypes based on patient examination. Cerebral palsy is divided into several subtypes, according to the primary underlying muscle abnormality and its distribution and severity. Classification of these subtypes is important for conducting rehabilitation research studies on patients with the same type of abnormality. However, doctors do not always classify cerebral palsy types in the same way. This study will examine methods for improving agreement among doctors in their classification of cerebral palsy subtypes.

Children between 6 and 18 years of age with cerebral palsy who can voluntarily move their arms and legs may be eligible for this study. Participants will be examined by at least three doctors or therapists. The examinations take 30-60 minutes. For the examination, a doctor or therapist will do the following:

- Observe the patient at rest

- Gently move the patient's arms and legs and then have the patient move his or her arms and legs

- Check the patient's reflexes

- Observe the patient walking, if the patient is able to walk

Patients will be asked to remain in the clinic for up to 3 hours while researchers discuss the examination and may be asked to repeat part of the study examination.

Sponsoring Institute:
National Institute of Neurological Disorders and Stroke (NINDS)
Recruitment Detail
Type: Active Accrual Of New Subjects
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): None

Eligibility Criteria:
INCLUSION CRITERIA:

1. Children 6 to 18 years of age

2. Children must be previously diagnosed with cerebral palsy

3. Children born at any gestational age will be eligible.

4. Lesions must be pre-, peri- or post-natal and acquired before 2 years of age

5. Lesions must be non-progressive

6. Patients must be able to voluntarily move their upper and lower limbs

EXCLUSION CRITERIA:

1. Any subject who is pregnant

2. Children with an underlying known genetic or chromosomal disorder

3. Children with clearly identified familial or non-familial syndromes (without known chromosomal or genetic defect)

4. Cerebral lesions acquired after 2 years of age

5. Patients with progressive or neurodegenerative disorders

6. Patients with spinal disorders in the absence of cerebral lesions

7. Patients with sickle cell disease

8. Patients with cerebral lesions caused by emboli associated with congenital cardiac lesions

9. Patients with severe cognitive deficits who cannot follow simple verbal commands

10. Patients incapable of voluntary movement of either upper or lower limbs due to contractures.

11. Patients with prior rhizotomy

12. Patients with prior orthopedic (bone or soft tissue) surgery or serial casting

13. Patients with severe postural abnormalities who cannot maintain supported sitting.

Special Instructions: Currently Not Provided
Keywords:
Reliability
Muscle Tone Abnormality
Spasticity
Dystonia
Rigidity
Recruitment Keywords:
Cerebral Palsy
CP
Children
Conditions:
Cerebral Palsy
Investigational Drug(s):
None
Investigational Device(s):
None

Contacts:
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

Citations:
Sanger TD, Delgado MR, Gaebler-Spira D, Hallett M, Mink JW; Task Force on Childhood Motor Disorders. Classification and definition of disorders causing hypertonia in childhood. Pediatrics. 2003 Jan;111(1):e89-97. Review.

Colver AF, Sethumadhavan T. The term diplegia should be abandoned. Arch Dis Child. 2003 Apr;88(4):286-90. Review. No abstract available.

Brashear A, Zafonte R, Corcoran M, Galvez-Jimenez N, Gracies JM, Gordon MF, McAfee A, Ruffing K, Thompson B, Williams M, Lee CH, Turkel C. Inter- and intrarater reliability of the Ashworth Scale and the Disability Assessment Scale in patients with upper-limb poststroke spasticity. Arch Phys Med Rehabil. 2002 Oct;83(10):1349-54.

Active Accrual, Protocols Recruiting New Patients

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