Cerebral Palsy InfantileSPS-PCNCT05657548
Study of Sagittal Pelvic Statics in the Sitting Position in Children With Cerebral Palsy
An observational study of Cerebral Palsy Infantile, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
Cerebral palsy is the leading cause of motor disability in children. Children with little or no walking (GMFCS III, IV and V) represent 43% of children with cerebral palsy, the majority of whom present pelvic and spinal deformities in the frontal and sagittal planes. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Cerebral Palsy Infantile
- What is being tested?
- spine and pelvis radiography
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 30 Oct 2023to Oct 2027
- 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 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children and adolescents from 4 to 17 years old with cerebral palsy GMFCS III, IV or V followed in the Physical Medicine and Rehabilitation Department, Children Rehabilitation Unit of the CHU of Nîmes
Who may be able to join
- Child or adolescent aged 4 to 17 years
- Child or adolescent with cerebral palsy GMFCS III, IV or V
- Child or adolescent whose parents, or the child if possible, have given free, informed and written consent
- Child or adolescent affiliated or beneficiary of a health insurance plan
Who cannot join
- Child or adolescent with history of spinal surgery
- Child or adolescent with parents unable to give consent
- Child or adolescent participating in a therapeutic research study (RIPH 1 or drug study)
- Child or adolescent in an exclusion period determined by another study
- Child or adolescent under court protection, guardianship or curatorship
- Pregnant, parturient or breastfeeding patient
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
CHU de Nîmes
Nîmes, 30029
Mélanie PORTE, +33466683459, melanie.porte@chu-nimes.fr
Cloé LAFFARGUE, +33466683459, cloe.laffargue@gmail.fr
About this study
Cerebral palsy is the leading cause of motor disability in children. Children with little or no walking (GMFCS III, IV and V) represent 43% of children with cerebral palsy, the majority of whom present pelvic and spinal deformities in the frontal and sagittal planes. However, sagittal pelvic spinal statics have been little studied, especially in the sitting position, which is the functional position of these children.
Moreover, there are currently no recommendations on how to perform follow-up radiographs of the spine in children who do not walk much.
Read more
A better understanding of pelvic and sagittal spinal statics would help prevent deformities and their complications.
Standardizing the method of performing pelvic-spinal radiographs in the sitting position will make monitoring of spinal statics more reliable.
- Conditions
- Cerebral Palsy Infantile
- Being tested
- spine and pelvis radiography
- Keywords
- Spine, Child, Adolescent, Pelvis, Postural Balance, Posture, Radiography
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spine and pelvis radiographyRadiation
X-ray of the spine and pelvis from the front and the side will be performed under the standardized conditions that we put in place: in a sitting position on a specific modular chair.
| Study group | Role | What they receive |
|---|---|---|
| Child with Cerebral Palsy | Children and adolescents from 4 to 17 years old with cerebral palsy GMFCS III, IV or V followed in the Physical Medicine and Rehabilitation Department, Children's Rehabilitation Unit of the University Hospital of Nîmes (Carémeau Hospital) Receives: Radiation: spine and pelvis radiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of the sagittal spinal statics in the sitting position
measurement of pelvic incidence (normal values between 35 and 85 degrees)
Measured: At baseline
Evolution of the sagittal spinal statics in the sitting position
sacral slope (angle of inclination of the sacral plateau in profile to the horizontal (degrees))
Measured: At baseline
Evolution of the sagittal spinal statics in the sitting position
pelvic version (angle between the vertical and the line joining the center of the femoral heads with the middle of the sacral plateau (in degrees))
Measured: At baseline
Evolution of the sagittal spinal statics in the sitting position
lordoses cervicales (in degrees)
Measured: At baseline
Evolution of the sagittal spinal statics in the sitting position
lumbar lordosis (in degrees)
Measured: At baseline
Evolution of the sagittal spinal statics in the sitting position
thoracic kyphosis (in degrees)
Measured: At baseline
Evolution of the sagittal spinal statics in the sitting position
Cobb angle (if scoliosis) (curvature greater than 10 degrees : definition of scoliosis; between 10 and 15 degree: benign scoliosis; between 15 and 35 degrees: moderate scoliosis; curvature greater than 35 degrees: significant scoliosis.)
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start30 Oct 2023
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy InfantileStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anissa MEGZARI, Study director, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05657548
- Sponsor's protocol ID
- Local/2022/CL-01
- Other IDs
- ANSM
- Acronym
- SPS-PC
- Status last verified
- Oct 2026
- First submitted
- 12 Dec 2022
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Sagittal Pelvic Statics in the Sitting Position in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05657548
- Acronym / sponsor ID
- SPS-PC / Local/2022/CL-01
- Conditions
- Cerebral Palsy Infantile
- Keywords
- Spine, Child, Adolescent, Pelvis, Postural Balance, Posture, Radiography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 20 Dec 2022 (actual)
- 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 is the leading cause of motor disability in children. Children with little or no walking (GMFCS III, IV and V) represent 43% of children with cerebral palsy, the majority of whom present pelvic and spinal deformities in the frontal and sagittal planes. However, sagittal pelvic spinal statics have been little studied, especially in the sitting position, which is the functional position of these children.
Moreover, there are currently no recommendations on how to perform follow-up radiographs of the spine in children who do not walk much.
A better understanding of pelvic and sagittal spinal statics would help prevent deformities and their complications.
Standardizing the method of performing pelvic-spinal radiographs in the sitting position will make monitoring of spinal statics more reliable.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Child with Cerebral Palsy | – | Radiation: spine and pelvis radiographyChildren and adolescents from 4 to 17 years old with cerebral palsy GMFCS III, IV or V followed in the Physical Medicine and Rehabilitation Department, Children's Rehabilitation Unit of the University Hospital of Nîmes (Carémeau Hospital) |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children and adolescents from 4 to 17 years old with cerebral palsy GMFCS III, IV or V followed in the Physical Medicine and Rehabilitation Department, Children Rehabilitation Unit of the CHU of Nîmes
Key inclusion criteria (4 listed)
- Child or adolescent aged 4 to 17 years
- Child or adolescent with cerebral palsy GMFCS III, IV or V
- Child or adolescent whose parents, or the child if possible, have given free, informed and written consent
- Child or adolescent affiliated or beneficiary of a health insurance plan
Key exclusion criteria (6 listed)
- Child or adolescent with history of spinal surgery
- Child or adolescent with parents unable to give consent
- Child or adolescent participating in a therapeutic research study (RIPH 1 or drug study)
- Child or adolescent in an exclusion period determined by another study
- Child or adolescent under court protection, guardianship or curatorship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spine and pelvis radiographyX-ray of the spine and pelvis from the front and the side will be performed under the standardized conditions that we put in place: in a sitting position on a specific modular chair. | Radiation | Child with Cerebral Palsy |
Primary outcome
Evolution of the sagittal spinal statics in the sitting position
Time frame: At baseline
measurement of pelvic incidence (normal values between 35 and 85 degrees)
Evolution of the sagittal spinal statics in the sitting position
Time frame: At baseline
sacral slope (angle of inclination of the sacral plateau in profile to the horizontal (degrees))
Evolution of the sagittal spinal statics in the sitting position
Time frame: At baseline
pelvic version (angle between the vertical and the line joining the center of the femoral heads with the middle of the sacral plateau (in degrees))
Evolution of the sagittal spinal statics in the sitting position
Time frame: At baseline
lordoses cervicales (in degrees)
Evolution of the sagittal spinal statics in the sitting position
Time frame: At baseline
lumbar lordosis (in degrees)
Evolution of the sagittal spinal statics in the sitting position
Time frame: At baseline
thoracic kyphosis (in degrees)
Evolution of the sagittal spinal statics in the sitting position
Time frame: At baseline
Cobb angle (if scoliosis) (curvature greater than 10 degrees : definition of scoliosis; between 10 and 15 degree: benign scoliosis; between 15 and 35 degrees: moderate scoliosis; curvature greater than 35 degrees: significant scoliosis.)
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 26 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Anissa MEGZARI study director
Centre Hospitalier Universitaire de Nīmes
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 Infantile, run by Centre Hospitalier Universitaire de Nīmes 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 4 inclusion and 6 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 26 Oct 2026. 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 Mélanie PORTE (+33 4.66.68.34.59, melanie.porte@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of the sagittal spinal statics in the sitting position (time frame: At baseline). The study lists 7 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 26 Oct 2026.