NCT01157494

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2010

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

July 6, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 7, 2010

Completed
Last Updated

July 7, 2010

Status Verified

April 1, 2010

Enrollment Period

2 months

First QC Date

July 6, 2010

Last Update Submit

July 6, 2010

Conditions

Keywords

cerebral palsyhemiplegiaupper limbassessmentclassification system

Outcome Measures

Primary Outcomes (1)

  • Assisting Hand Assessment (AHA)

    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 Outcomes (1)

  • Melbourne Assessment of Unilateral Upper Limb Function (Melbourne Assessment)

    the 2 assessment has to be registered within 6 months

Study Arms (1)

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

Interventions

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).

children with hemiplegia

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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).

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Azienda Santa Maria Nuova in Reggio Emilia

Reggio Emilia, RE, 42100, Italy

Location

MeSH Terms

Conditions

HemiplegiaCerebral Palsy

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBrain Damage, ChronicBrain DiseasesCentral Nervous System Diseases

Study Officials

  • Adriano Ferrari, MD

    University of Modena and Reggio Emilia and Hospital Santa Maria Nuova

    STUDY CHAIR
  • Giulia Borelli, PT

    Azienda USL Reggio Emilia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 6, 2010

First Posted

July 7, 2010

Study Start

April 1, 2010

Primary Completion

June 1, 2010

Study Completion

July 1, 2010

Last Updated

July 7, 2010

Record last verified: 2010-04

Locations