Validity of Manipulation Taxonomy of Spastic Hemiplegic Cerebral Palsy (CP) Forms

This study has been completed.
Sponsor:
Collaborator:
Arcispedale Santa Maria Nuova-IRCCS
Information provided by:
University of Modena and Reggio Emilia
ClinicalTrials.gov Identifier:
NCT01157494
First received: July 6, 2010
Last updated: NA
Last verified: April 2010
History: No changes posted
  Purpose

In recent years Ferrari et al. proposed a new classification of manipulation in children with spastic hemiplegia which describes five different classes by analyzing and integrating the kinematic patterns of the hand and its functional use.

The investigators believe that this classification provides the clinician with clinically meaningful information, by identifying the useful strategies spontaneously adopted by the children during manipulation tasks.

The aim of this study is to determine the criterion validity of the new classification of the pattern of manipulation in children with spastic hemiplegia by correlating hand manipulation classes with both the scores of the Assisting Hand Assessment and the scores of the Melbourne Assessment of Unilateral Upper Limb Function.


Condition Intervention
Hemiplegia
Cerebral Palsy
Other: classification of hand manipulation function

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Validity of Manipulation Taxonomy of Spastic Hemiplegic Cerebral Palsy Forms Proposed by Ferrari A et.al.

Resource links provided by NLM:


Further study details as provided by University of Modena and Reggio Emilia:

Primary Outcome Measures:
  • Assisting Hand Assessment (AHA) [ Time Frame: the 2 assessment has to be registered within 6 months ] [ Designated as safety issue: No ]
    correlation between the new classification of hand manipulation function and the AHA which measures the bi-manual performance, i.e. what the child usually does with the plegic hand


Secondary Outcome Measures:
  • Melbourne Assessment of Unilateral Upper Limb Function (Melbourne Assessment) [ Time Frame: the 2 assessment has to be registered within 6 months ] [ Designated as safety issue: No ]
    correlation between the new classification of hand manipulation function and the Melbourne Assessment which measures the bi-manual performance, i.e. what the child usually does with the plegic hand


Enrollment: 30
Study Start Date: April 2010
Study Completion Date: July 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
children with hemiplegia
To determine the criterion validity of the classification of the pattern of manipulation proposed by Ferrari et al. we correlated hand manipulation classes with both the scores of the two standard criteria chosen (AHA and Melbourne Assessment).
Other: classification of hand manipulation function
To determine the criterion validity of the classification of the pattern of manipulation proposed by Ferrari et al. we correlated hand manipulation classes with both the scores of the two standard criteria chosen (AHA and Melbourne Assessment).

  Eligibility

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

We retrospectively studied children with hemiplegia and CP who are followed by the Unit for Severe Disability in the Developmental Age at the Hospital of Reggio Emilia (Italy).

Criteria

Inclusion criteria:

  • clinical and instrumental (TC or RMN) diagnosis of child hemiplegia
  • age > 5 years

Exclusion criteria:

  • acquired hemiplegia at the age > 3 years
  • anti-spastic drug inoculations or functional surgery on the plegic UE 6 months prior to the video recordings
  • severe mental retardation attested by the Diagnostic and Statistical Manual of mental disorders IV
  • pharmaco-resistant epilepsy
  • behavioural disorders
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01157494

Locations
Italy
Hospital Azienda Santa Maria Nuova in Reggio Emilia
Reggio Emilia, RE, Italy, 42100
Sponsors and Collaborators
University of Modena and Reggio Emilia
Arcispedale Santa Maria Nuova-IRCCS
Investigators
Study Chair: Adriano Ferrari, MD University of Modena and Reggio Emilia and Hospital Santa Maria Nuova
Principal Investigator: Giulia Borelli, PT Azienda USL Reggio Emilia
  More Information

No publications provided

Responsible Party: Adriano Ferrari, University of Modena and Reggio Emilia and Hospital Azienda Santa Maria Nuova Reggio Emilia
ClinicalTrials.gov Identifier: NCT01157494     History of Changes
Other Study ID Numbers: UDGEE_2010_hand_class
Study First Received: July 6, 2010
Last Updated: July 6, 2010
Health Authority: Italy: Ministry of Health

Keywords provided by University of Modena and Reggio Emilia:
cerebral palsy
hemiplegia
upper limb
assessment
classification system

Additional relevant MeSH terms:
Cerebral Palsy
Hemiplegia
Paralysis
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 27, 2014