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OpenTrials
Completed

NCT Number: NCT02834195

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.

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Key information

Age range

2 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Lyon, 69424, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • cerebral palsy

Exclusion criteria

  • none

Treatment and study plan

Primary outcomes

  1. 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.

  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.

  3. 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.

  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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: CLASS-MS

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 15, 2016
Registry last updated
Jul 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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