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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01157494
• Other study ID #: UDGEE_2010_hand_class
• Status: Completed
• Phase: N/A
• First received: July 6, 2010
• Last updated: July 6, 2010
• Start date: April 2010
• Est. completion date: July 2010

Study information

• Verified date: April 2010
• Source: University of Modena and Reggio Emilia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 18 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Cerebral Palsy
• Hemiplegia

Intervention

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).

Locations

Country	Name	City	State
Italy	Hospital Azienda Santa Maria Nuova in Reggio Emilia	Reggio Emilia	RE

Sponsors (2)

Lead Sponsor	Collaborator
University of Modena and Reggio Emilia	Arcispedale Santa Maria Nuova-IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Melbourne Assessment of Unilateral Upper Limb Function (Melbourne Assessment)	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	No