Types of Upper Limb and Hand in Patients With Cerebral Palsy (CLASS-MS)

July 18, 2016 updated by: Hospices Civils de Lyon

Validation of a Classification of Types of Upper Limb and Hand in Patients With Cerebral Palsy

Cerebral palsy (CP) has been defined as "a group of permanent disorders of the development of movement and posture causing activity limitation(s) that are attributed to non-progressive disturbances that occurred in the developing fetal or infant brain".

Investigators previously developed two classification systems, one for the upper limb and one for the hand, based on 100 films of patients with cerebral palsy. Separate classifications were developed following an initial study in which investigators found no correlations between upper limb and hand patterns, meaning that specific upper limb patterns are not always associated with specific hand patterns. Thumb patterns were not included in these classifications since robust classifications already exist, moreover thumb patterns are independent from hand patterns.

The aim is to evaluate the inter- and intra-rater reliability of two previously developed classifications of upper limb and hand patterns.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

111

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

  • France
      • Lyon, France, 69424
        • Hospices Civils de Lyon, Pôle Information Médicale, Evaluation, Recherche - 162 avenue Lacassagne - Bâtiment A

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

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with cerebral palsy

Description

Inclusion Criteria:

  • cerebral palsy

Exclusion Criteria:

  • none

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in upper limb pattern classification of each examiner between day 1 and month 2
Time Frame: examiner classification at day 1 and at month 2.
Intra-rater reliability of a classification of upper limb pattern in patients with cerebral palsy.
examiner classification at day 1 and at month 2.
Change in hand pattern classification of each examiner between day 1 and month 2
Time Frame: examiner classification at day 1 and at month 2.
Intra-rater reliability of a classification of hand pattern in patients with cerebral palsy.
examiner classification at day 1 and at month 2.
Change between examiner classification and the expert examiner classification
Time Frame: Expert examiner classification (day 1) and examiner classification (week 4)
Level of agreement will be determined with Fleiss's kappa (k) and its 95% confidence interval Inter-rater reliability of a classification of upper limb pattern in patients with cerebral palsy.
Expert examiner classification (day 1) and examiner classification (week 4)
Change between examiner classification and the expert examiner classification
Time Frame: Expert examiner classification (day 1) and examiner classification (week 4)

Level of agreement will be determined with Fleiss's kappa (k) and its 95% confidence interval.

Inter-rater reliability of a classification of hand pattern in patients with cerebral palsy.
Expert examiner classification (day 1) and examiner classification (week 4)

Collaborators and Investigators

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

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Sandrine TOUZET, MD, Hospices Civils de Lyon, Pôle Information Médicale, Evaluation, Recherche

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

June 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

July 4, 2016

First Submitted That Met QC Criteria

July 12, 2016

First Posted (Estimate)

July 15, 2016

Study Record Updates

Last Update Posted (Estimate)

July 19, 2016

Last Update Submitted That Met QC Criteria

July 18, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D21882

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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