NCT01158833

Brief Summary

In recent years Ferrari et al. proposed a new classification of gait in diplegic children with spastic diplegia that describes four different patterns of gait by analyzing the strategies that each children adopts to need his/her needs to walk. The investigators believe that this classification provides the clinician with clinically meaningful information in terms of coping strategies adopted to maximize the ability to walk. The aim of this study is to determine the criterion validity of the new classification of the pattern of gait in children with spastic diplegia by correlating pattern of diplegic gait with the score of the Functional performance measure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 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
3 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 8, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

June 27, 2014

Status Verified

June 1, 2014

Enrollment Period

5 months

First QC Date

July 6, 2010

Last Update Submit

June 26, 2014

Conditions

Keywords

Cerebral palsydiplegiagaitclassification

Outcome Measures

Primary Outcomes (1)

  • Functional Mobility Scale (FMS)

    correlation between the new classification of diplegic gait and the FMS which classifies the functional mobility in children

    at the age of 12 to 17 years

Study Arms (1)

spastic diplegia due to Cerebral Palsy

Other: classification of gait in diplegic children with CP

Interventions

To determine the criterion validity of the classification of the pattern of diplegic gait proposed by Ferrari et al. we correlated gait patterns with the score of the FMS.

spastic diplegia due to Cerebral Palsy

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

We retrospectively studied children with diplegia 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:

  • diplegia and CP;

You may not qualify if:

  • 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)

Arcispedale Santa Maria Nuova

Reggio Emilia, RE, 42100, Italy

Location

Related Publications (3)

  • Pascale R, Perazza S, Borelli G, Bianchini E, Alboresi S, Paolicelli PB, Ferrari A, Cioni G. The term diplegia should be enhanced. Part III: inter-observer reliability of the new rehabilitation oriented classification. Eur J Phys Rehabil Med. 2008 Jun;44(2):213-20.

    PMID: 18418341BACKGROUND
  • Cioni G, Lodesani M, Pascale R, Coluccini M, Sassi S, Paolicelli PB, Perazza S, Ferrari A. The term diplegia should be enhanced. Part II: contribution to validation of the new rehabilitation oriented classification. Eur J Phys Rehabil Med. 2008 Jun;44(2):203-11.

    PMID: 18418340BACKGROUND
  • Ferrari A, Alboresi S, Muzzini S, Pascale R, Perazza S, Cioni G. The term diplegia should be enhanced. Part I: a new rehabilitation oriented classification of cerebral palsy. Eur J Phys Rehabil Med. 2008 Jun;44(2):195-201.

    PMID: 18418339BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Adriano Ferrari, MD

    University of Modena and Reggio Emilia and Hospital Santa Maria Nuova

    STUDY CHAIR
  • Stefania Costi, PT

    University of Modena and Reggio Emilia

    STUDY DIRECTOR
  • Rita Neviani, PT

    Azienda USL Reggio Emilia - IRCCS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical Therapist

Study Record Dates

First Submitted

July 6, 2010

First Posted

July 8, 2010

Study Start

April 1, 2010

Primary Completion

September 1, 2010

Study Completion

November 1, 2010

Last Updated

June 27, 2014

Record last verified: 2014-06

Locations