NCT00072800

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 10, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 11, 2003

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
Last Updated

March 4, 2008

Status Verified

August 1, 2005

First QC Date

November 10, 2003

Last Update Submit

March 3, 2008

Conditions

Cerebral Palsy

Keywords

ReliabilityMuscle Tone AbnormalitySpasticityDystoniaRigidityCerebral PalsyCPChildren

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Neurological Disorders and Stroke (NINDS)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • 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.

    PMID: 12509602BACKGROUND

  • Colver 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.

    PMID: 12651747BACKGROUND

  • 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. doi: 10.1053/apmr.2002.35474.

    PMID: 12370866BACKGROUND

MeSH Terms

Conditions

Cerebral PalsyMuscle SpasticityDystoniaMuscle Rigidity

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDyskinesias

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 10, 2003

First Posted

November 11, 2003

Study Start

November 1, 2003

Study Completion

August 1, 2005

Last Updated

March 4, 2008

Record last verified: 2005-08

Locations

US(1)