Types of Upper Limb and Hand in Patients With Cerebral Palsy

Cerebral Palsy Clinical Trial

— CLASS-MS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02834195
• Other study ID #: D21882
• Status: Completed
• Phase: N/A
• First received: July 4, 2016
• Last updated: July 18, 2016
• Start date: June 2013
• Est. completion date: June 2014

Study information

• Verified date: June 2016
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: The Commission nationale de l’informatique et des libertés
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years and older

Eligibility

Inclusion Criteria:

• cerebral palsy

Exclusion Criteria:

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

Locations

Country	Name	City	State
France	Hospices Civils de Lyon, Pôle Information Médicale, Evaluation, Recherche - 162 avenue Lacassagne - Bâtiment A	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Primary	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.	No
Primary	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)	No
Primary	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)	No