NCT02834195

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
111

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2013

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

June 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

July 4, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 15, 2016

Completed
Last Updated

July 19, 2016

Status Verified

June 1, 2016

Enrollment Period

1 year

First QC Date

July 4, 2016

Last Update Submit

July 18, 2016

Conditions

Keywords

Cerebral palsyreliabilityupper limb and hand patternsclassification

Outcome Measures

Primary Outcomes (4)

  • Change in upper limb pattern classification of each examiner between day 1 and 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

    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

    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

    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)

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with cerebral palsy

You may qualify if:

  • cerebral palsy

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Lyon, 69424, France

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Sandrine TOUZET, MD

    Hospices Civils de Lyon, Pôle Information Médicale, Evaluation, Recherche

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2016

First Posted

July 15, 2016

Study Start

June 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

July 19, 2016

Record last verified: 2016-06

Locations