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

July 6, 2010 updated by: University of Modena and Reggio Emilia

Validity of Manipulation Taxonomy of Spastic Hemiplegic Cerebral Palsy Forms Proposed by Ferrari A et.al.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • RE
      • Reggio Emilia, RE, Italy, 42100
        • Hospital Azienda Santa Maria Nuova in Reggio Emilia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assisting Hand Assessment (AHA)
Time Frame: the 2 assessment has to be registered within 6 months
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
the 2 assessment has to be registered within 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Melbourne Assessment of Unilateral Upper Limb Function (Melbourne Assessment)
Time Frame: the 2 assessment has to be registered within 6 months
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
the 2 assessment has to be registered within 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Modena and Reggio Emilia

Collaborators

Arcispedale Santa Maria Nuova-IRCCS

Investigators

  • Principal Investigator: Giulia Borelli, PT, Azienda USL Reggio Emilia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (ACTUAL)

June 1, 2010

Study Completion (ACTUAL)

July 1, 2010

Study Registration Dates

First Submitted

July 6, 2010

First Submitted That Met QC Criteria

July 6, 2010

First Posted (ESTIMATE)

July 7, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

July 7, 2010

Last Update Submitted That Met QC Criteria

July 6, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDGEE_2010_hand_class

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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