Orthopedic Complications in Cerebral PalsyCPCohortNCT01840930
Cohort of Children With Severe Cerebral Palsy
An observational study of Orthopedic Complications in Cerebral Palsy, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
" Cohort CP " is a multicentre cohort study, initiated by the Hospices Civils de Lyon in September 2009. Population targeted are children with bilateral cerebral palsy, level GMFCS IV or V, aged from 2 to 10 years at inclusion. They are followed-up during 10 years, at the rhythm of 1 visit per year. Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- Orthopedic Complications in Cerebral Palsy
- How many people
- 385 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2009to Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: Children aged from 2 to 10 years, with severe cerebral palsy: who do not acquire the ability to walk.
Who may be able to join
- Children aged from 2 to 10 years at inclusion,
- with bilateral cerebral palsy,
- Grade IV or V of the GMFCS.
- Affiliated with the French healthcare system.
- Oral consent of the parents obtained.
Who cannot join
- Progressive pathology.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hospices Civils de Lyon - Hôpital Femme Mère Enfant
Bron, 69677
Isabelle POIROT, PhD, 4 78 86 16 64 ext. +33, isabelle.poirot@chu-lyon.fr
Valérie LAUDY, 4 72 35 75 51 ext. +33, valerie.laudy@chu-lyon.fr
About this study
Official title: Longitudinal Study of a Children Population With Bilateral Severe Cerebral Palsy: Incidence and Evolution of Orthopaedic Complications and Pain Related With These Complications.
" Cohort CP " is a multicentre cohort study, initiated by the Hospices Civils de Lyon in September 2009. Population targeted are children with bilateral cerebral palsy, level GMFCS IV or V, aged from 2 to 10 years at inclusion. They are followed-up during 10 years, at the rhythm of 1 visit per year. At each visit are collected clinical, orthopaedic, radiological and environmental data.
The primary objective is to establish the incidence of orthopaedic complications (scoliosis and hip joint) depending on patients' age.
Read more
Secondary objectives are to describe the sequences over time of these complications and the related pain, to explore the impact of nutrition, surgery, asymmetric postures and environmental factors, and to describe the medical and rehabilitative follow-up of these patients.
385 patients are expected by the end of 2020. We expect of this long-term follow-up to gain tools that permit to improve patient's care and patient's quality of life, by putting in place preventing actions and adapted treatments related to their own pathologies.
- Keywords
- Cohort, Cerebral Palsy, Children, Pain, Orthopedic complications, Epidemiology
- Medical subject headings
- Cerebral Palsy, Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of hip migration (%) and/or scoliosis (Cobb angle) during the 10 years of patients' follow-up.
Hip migration is measured in percentage (Rimers method), and scoliosis is measured in degrees (Cobb angle).
For the first visit (A00= inclusion), if hip migration measured on the last radiography is ≥ 20%, it is asked to trace the history of the migration with measurements of previous patient's radiographies. For this first visit, if the Cobb angle on the last radiography is ≥ 20°, it is also asked to trace history of scoliosis with previous radiographies.
For the following visits (A01 to A10), only the last radiography is required for each year.
Measured: Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10
Secondary outcomes (7)
Impact of nutrition on the occurrence of orthopedic complications and related pain.
Occurrence of hip migration or scoliosis correlated with annual measurement of nutritional state. Nutritional state is measured by weight, size, skinfold, and description of alimentation mode.
Measured: Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10
Impact of surgical treatment of hip luxation on pain.
Subjects split into 2 groups: pain / without pain; comparison of percentages of children operated into each group.
Measured: Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10
Impact of asymmetric postures on the occurrence of orthopedic complications and related pain.
Frequency of windswept attitude function of type of bearings and postures.
Measured: Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10
Relationship between neurological asymmetry and windswept and/or hip joint.
Frequency of neurological asymmetry function of windswept laterality and/or hip joint.
Measured: Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10
Relationship between environmental factors and orthopedic complications, pain, and nutrition.
Correlation between patient's environment, hip migration and scoliosis, pain and nutrition.
Measured: Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10
Description of the rehabilitative and medical follow-up in the studied population.
Recording of the main steps of medical and rehabilitative care received by each patient.
Measured: Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10
Description of the sequences over time of orthopedic complications and the related pain.
Pattern of individual evolution of pain function of age, and quantification of orthopedic surgery impact on pain evolution.
Pain is measured with the DESS scale (Douleur Enfant San Salvadour) for children with no oral language, or with the VAS (Visual Analogue Scale) for children who have an oral language. In addition, the location, the frequency and the length of time of the related pain are recorded on the Case Report Form.
Measured: Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2013 (estimated)
- Study startSep 2009
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic Complications in 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 385 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle POIROT, PhD, Principal investigator, Hospices Civils de Lyon - Hôpital Femme Mère Enfant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01840930
- Sponsor's protocol ID
- D50687
- Acronym
- CPCohort
- Status last verified
- Jan 2020
- First submitted
- 5 Apr 2013
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Study of a Children Population With Bilateral Severe Cerebral Palsy: Incidence and Evolution of Orthopaedic Complications and Pain Related With These Complications.
- ClinicalTrials.gov ID
- NCT01840930
- Acronym / sponsor ID
- CPCohort / D50687
- Keywords
- Cohort, Cerebral Palsy, Children, Pain, Orthopedic complications, Epidemiology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 385 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Sep 2009 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 26 Apr 2013 (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.
" Cohort CP " is a multicentre cohort study, initiated by the Hospices Civils de Lyon in September 2009. Population targeted are children with bilateral cerebral palsy, level GMFCS IV or V, aged from 2 to 10 years at inclusion. They are followed-up during 10 years, at the rhythm of 1 visit per year. At each visit are collected clinical, orthopaedic, radiological and environmental data.
The primary objective is to establish the incidence of orthopaedic complications (scoliosis and hip joint) depending on patients' age.
Secondary objectives are to describe the sequences over time of these complications and the related pain, to explore the impact of nutrition, surgery, asymmetric postures and environmental factors, and to describe the medical and rehabilitative follow-up of these patients.
385 patients are expected by the end of 2020. We expect of this long-term follow-up to gain tools that permit to improve patient's care and patient's quality of life, by putting in place preventing actions and adapted treatments related to their own pathologies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged from 2 to 10 years, with severe cerebral palsy: who do not acquire the ability to walk.
Key inclusion criteria (5 listed)
- Children aged from 2 to 10 years at inclusion,
- with bilateral cerebral palsy,
- Grade IV or V of the GMFCS.
- Affiliated with the French healthcare system.
- Oral consent of the parents obtained.
Key exclusion criteria (1 listed)
- Progressive pathology.
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 of hip migration (%) and/or scoliosis (Cobb angle) during the 10 years of patients' follow-up.
Time frame: Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10
Hip migration is measured in percentage (Rimers method), and scoliosis is measured in degrees (Cobb angle). For the first visit (A00= inclusion), if hip migration measured on the last radiography is ≥ 20%, it is asked to trace the history of the migration with measurements of previous patient's radiographies. For this first visit, if the Cobb angle on the last radiography is ≥ 20°, it is also asked to trace history of scoliosis with previous radiographies. For the following visits (A01 to A10), only the last radiography is required for each year.
7 secondary outcomes
Impact of nutrition on the occurrence of orthopedic complications and related pain.
Time frame: Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10
Impact of surgical treatment of hip luxation on pain.
Time frame: Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10
Impact of asymmetric postures on the occurrence of orthopedic complications and related pain.
Time frame: Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10
Relationship between neurological asymmetry and windswept and/or hip joint.
Time frame: Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10
Relationship between environmental factors and orthopedic complications, pain, and nutrition.
Time frame: Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10
Description of the rehabilitative and medical follow-up in the studied population.
Time frame: Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10
Description of the sequences over time of orthopedic complications and the related pain.
Time frame: Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
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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.
Isabelle POIROT, PhD principal investigator
Hospices Civils de Lyon - Hôpital Femme Mère Enfant
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 Orthopedic Complications in 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 5 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: looking for participants now, as of the sponsor's last update on 18 Jan 2020. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Isabelle POIROT, PhD (4 78 86 16 64 ext. +33, isabelle.poirot@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of hip migration (%) and/or scoliosis (Cobb angle) during the 10 years of patients' follow-up. (time frame: Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10). 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 18 Jan 2020.