Cerebral PalsyCLASS-MSNCT02834195
Types of Upper Limb and Hand in Patients With Cerebral Palsy
An observational study of Cerebral Palsy, run by Hospices Civils de Lyon at 1 site in France.
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". Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Cerebral Palsy
- How many people
- 111 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2013to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with cerebral palsy
Who may be able to join
- cerebral palsy
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
France1 site
Hospices Civils de Lyon, Pôle Information Médicale, Evaluation, Recherche - 162 avenue Lacassagne - Bâtiment A
Lyon, 69424
About this study
Official title: 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.
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral palsy, reliability, upper limb and hand patterns, classification
- Medical subject headings
- Cerebral Palsy
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Expert examiner classification (day 1) and examiner classification (week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2016 (estimated)
- Study startJun 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandrine TOUZET, MD, Principal investigator, Hospices Civils de Lyon, Pôle Information Médicale, Evaluation, Recherche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02834195
- Sponsor's protocol ID
- D21882
- Acronym
- CLASS-MS
- Status last verified
- Jun 2016
- First submitted
- 4 Jul 2016
- Last updated
- 19 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Classification of Types of Upper Limb and Hand in Patients With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT02834195
- Acronym / sponsor ID
- CLASS-MS / D21882
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral palsy, reliability, upper limb and hand patterns, classification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 15 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with cerebral palsy
Key inclusion criteria (1 listed)
- cerebral palsy
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2016.
Related trials for Cerebral Palsy
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
Cerebral Palsy
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandrine TOUZET, MD principal investigator
Hospices Civils de Lyon, Pôle Information Médicale, Evaluation, Recherche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2016.