Cerebral PalsyNCT00072800
Classification of Cerebral Palsy Subtypes
An observational study of Cerebral Palsy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cerebral Palsy
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2003to Aug 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Children 6 to 18 years of age
- Children must be previously diagnosed with cerebral palsy
- Children born at any gestational age will be eligible.
- Lesions must be pre-, peri- or post-natal and acquired before 2 years of age
- Lesions must be non-progressive
- Patients must be able to voluntarily move their upper and lower limbs
Who cannot join
- Any subject who is pregnant
- Children with an underlying known genetic or chromosomal disorder
- Children with clearly identified familial or non-familial syndromes (without known chromosomal or genetic defect)
- Cerebral lesions acquired after 2 years of age
- Patients with progressive or neurodegenerative disorders
- Patients with spinal disorders in the absence of cerebral lesions
Show all 13Show fewer
- Patients with sickle cell disease
- Patients with cerebral lesions caused by emboli associated with congenital cardiac lesions
- Patients with severe cognitive deficits who cannot follow simple verbal commands
- Patients incapable of voluntary movement of either upper or lower limbs due to contractures.
- Patients with prior rhizotomy
- Patients with prior orthopedic (bone or soft tissue) surgery or serial casting
- Patients with severe postural abnormalities who cannot maintain supported sitting.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892
About this study
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:
Read more
- 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.
Read the 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.
- Conditions
- Cerebral Palsy
- Keywords
- Reliability, Muscle Tone Abnormality, Spasticity, Dystonia, Rigidity, Cerebral Palsy, CP, Children
- Medical subject headings
- Cerebral Palsy, Muscle Spasticity, Dystonia, Muscle Rigidity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2003 (estimated)
- Study startNov 2003
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 115 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00072800
- Sponsor's protocol ID
- 040034
- Other IDs
- 04-N-0034
- Status last verified
- Aug 2005
- First submitted
- 10 Nov 2003
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
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. doi: 10.1542/peds.111.1.e89.
PubMed 12509602Colver AF, Sethumadhavan T. The term diplegia should be abandoned. Arch Dis Child. 2003 Apr;88(4):286-90. doi: 10.1136/adc.88.4.286. No abstract available.
PubMed 12651747Brashear 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. doi: 10.1053/apmr.2002.35474.
PubMed 12370866
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Classification of Cerebral Palsy Subtypes
- ClinicalTrials.gov ID
- NCT00072800
- Acronym / sponsor ID
- 040034
- Conditions
- Cerebral Palsy
- Keywords
- Reliability, Muscle Tone Abnormality, Spasticity, Dystonia, Rigidity, Cerebral Palsy, CP, Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Nov 2003
- Study completion
- Aug 2005
- First posted
- 11 Nov 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Children 6 to 18 years of age
- Children must be previously diagnosed with cerebral palsy
- Children born at any gestational age will be eligible.
- Lesions must be pre-, peri- or post-natal and acquired before 2 years of age
- Lesions must be non-progressive
Key exclusion criteria (13 listed)
- Any subject who is pregnant
- Children with an underlying known genetic or chromosomal disorder
- Children with clearly identified familial or non-familial syndromes (without known chromosomal or genetic defect)
- Cerebral lesions acquired after 2 years of age
- Patients with progressive or neurodegenerative disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 12509602Sanger 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. doi: 10.1542/peds.111.1.e89.
- Background: PubMed 12651747Colver AF, Sethumadhavan T. The term diplegia should be abandoned. Arch Dis Child. 2003 Apr;88(4):286-90. doi: 10.1136/adc.88.4.286. No abstract available.
- Background: PubMed 12370866Brashear 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. doi: 10.1053/apmr.2002.35474.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00072800, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.