Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00072800
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2003-11-10
Brief Title:
Classification of Cerebral Palsy Subtypes
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Classification of Cerebral Palsy Subtypes
Status:
COMPLETED
Status Verified Date:
2005-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study conducted at the National Institutes of Health and the Childrens 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 patients arms and legs and then have the patient move his or her arms and legs
Check the patients 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
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 patients arms and legs and then have the patient move his or her arms and legs
Check the patients 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
Detailed Description:
The movement and posture abnormalities that are characteristic of cerebral palsy are associated with underlying abnormalities of muscle tone including dystonia spasticity and rigidity The subtypes of cerebral palsy are defined according to the predominant muscle tone abnormality its distribution and severity There is widespread agreement that CP subtypes should be divided into the following groups Spastic subtypes hemiplegia unilateral asymmetric spasticity diplegia bilateral symmetric spasticity lower limbs more affected than upper limbs quadriplegia bilateral symmetric spasticity upper and lower limbs affected equally dystonic or athetotic type and other miscellaneous types hypotonic mixed types etc These descriptive definitions are not useful when forming homogeneous cohorts of CP subtypes in rehabilitation research studies Even when a preceding training session establishes precise criteria for each subtype based on these definitions and uses a four limb approach defining the dominant muscle tone abnormality and its severity in each limb the interobserver agreement in the classification of CP subtypes remains poor This may be because there are no widely accepted definitions for the most common muscle tone abnormalities in cerebral palsy spasticity rigidity dystonia and examination methods vary widely Recently an interdisciplinary group of clinicians published a consensus document in which they set forth clear definitions for these disorders of muscle tone and recommendations on how to examine for them Since the CP subtypes are defined according to the dominant muscle tone abnormality we hypothesize that it may be possible to achieve acceptable interobserver agreement in the classification of the CP subtypes if these definitions and standard examination techniques are incorporated into the preceding training session with the other accepted elements To test this hypothesis we will train clinicians from three different areas of expertise child neurology physiatry physical therapy to classify subtypes of CP using accepted methods establishing precise criteria for the subtypes and using a four limb approach and will also train them to identify muscle tone abnormalities using the definitions and standard examination techniques in the consensus document Following this training we will ask the same clinicians to classify subtypes of cerebral palsy in a group of CP children We will then measure interobserver agreement for the classification of CP using the kappa statistic Achieving acceptable interobserver agreement in the classification of CP subtypes may facilitate the formation of homogeneous cohorts in research studies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04-N-0034 | None | None | None |