Exploring Hypertonia in Children With Cerebral Palsy

NCT01744158 | Unknown

• 1 other identifier: REC2202/8/12
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Abnormal limb and trunk movements are seen in many children with cerebral palsy. Recognizing the difference between types of these movements is not well understood. This study aims to describe how common are these movements in children recruited from a population-based sample of children identified on a cerebral palsy register, and to explore associations with motor abilities. It is hoped this will lead to improved understanding and recognition of movement disorders in CP, to allow clinicians to choose appropriate treatments. We hypothesise that the underlying prevalence of dyskinesia is higher than that previously identified through conventional motor descriptions in cerebral palsy populations in Australia, and may approach 20%.

Conditions

Cerebral Palsy.

Keywords

cerebral palsy; spasticity; dystonia; hypertonia; register; motor function

Outcome Measures

Primary Outcomes (2)

• Hypertonia Assessment Tool-Discriminate (HAT-D)

  The Hypertonia Assessment Tool (HAT) is a seven-item standardised clinical assessment tool used to differentiate the various types of paediatric hypertonia. There are 2 spasticity items, 2 rigidity items and 3 dystonia items and a standardized protocol for administration has been developed. Each item is scored yes or no. A positive score for at least one item of the subgroup confirms the presence of the subtype of hypertonia in the limb examined.

  One hour

• Barry-Albright Dystonia scale

  The Barry-Albright Dystonia scale is a 5-point criterion-based ordinal scale for measuring dystonia in CP, with sound validity and reliability. 7 It assesses dystonia in 8 body regions: eyes, mouth, neck, trunk, and the 4 extremities. Severity is scored from none to severe, with each body region having specific descriptors for scoring.

  One hour

Secondary Outcomes (1)

• Modified Ashworth Scale

  One hour

Study Arms (1)

Children with cerebral palsy

No intervention applicable

Other: No intervention applicable

Interventions

No intervention applicable OTHER

Following consent, children will undergo a comprehensive assessment performed by a research team including rehabilitation paediatrician and therapist. Hypertonia and abnormal movements will be assessed by a pediatrician with expertise in treating children with movement disorders. The assessments will be performed at a rehabilitation clinic, or child's home, and will include: * differentiation of hypertonia by application of the Hypertonia Assessment Tool-Discriminate (HAT-D) * measurement of severity of dystonia using the Barry Albright dystonia scale, based on video recording * measurement of severity of spasticity using the modified Ashworth score * description of presence of chorea or athetosis * classification of gross motor abilities using the GMFCS and functional mobility scale (FMS) * classification of fine motor abilities using the manual ability classification system (MACS) * collection of demographic data and associated medical history

Children with cerebral palsy

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be those with cerebral palsy attending Rehabilitation clinics at the Women's and Children's Hospital.

You may qualify if:

• children with a confirmed diagnosis of cerebral palsy
• aged between 2 and 18 years

You may not qualify if:

• presence of any progressive neurological disorder, including forms of genetic dystonia
• children less than two years, or greater than 18 years of age

Sponsors & Collaborators

• Women's and Children's Hospital, Australia: lead
• Allergan Australia Pty Ltd: collaborator

Study Sites (1)

Women's and Children's Hospital

Adelaide, South Australia, 5006, Australia

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy; Muscle Spasticity; Dystonia; Muscle Hypertonia

Condition Hierarchy (Ancestors)

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

Study Officials

• James E Rice, MD

  Women's and Children's Health Network

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James E Rice, MD

CONTACT

+618 8161 7367; james.rice@health.sa.gov.au

Remo N Russo, MD

CONTACT

+618 8161 7367

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant in Rehabilitation Medicine

Study Record Dates

• First Submitted: August 21, 2012
• First Posted: December 6, 2012
• Study Start: March 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: January 1, 2014
• Last Updated: December 6, 2012

Record last verified: 2012-12

Locations

AU (1)