Types of Upper Limb and Hand in Patients With Cerebral Palsy
CLASS-MS
Validation of a Classification of Types of Upper Limb and Hand in Patients With Cerebral Palsy
1 other identifier
observational
111
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2013
Shorter than P25 for all trials
1 active site
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 4, 2016
CompletedFirst Posted
Study publicly available on registry
July 15, 2016
CompletedJuly 19, 2016
June 1, 2016
1 year
July 4, 2016
July 18, 2016
Conditions
Keywords
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
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sandrine TOUZET, MD
Hospices Civils de Lyon, Pôle Information Médicale, Evaluation, Recherche
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