Studies
| Study First Submitted Date | 2022-12-12 |
| Study First Posted Date | 2022-12-20 |
| Last Update Posted Date | 2023-08-03 |
| Start Month Year | October 2023 |
| Primary Completion Month Year | March 2026 |
| Verification Month Year | August 2023 |
| Verification Date | 2023-08-31 |
| Last Update Posted Date | 2023-08-03 |
Facilities
| Sequence: | 200129891 |
| Name | CHU de Nîmes |
| City | Nîmes |
| Zip | 30029 |
| Country | France |
Facility Contacts
| Sequence: | 28109699 | Sequence: | 28109700 |
| Facility Id | 200129891 | Facility Id | 200129891 |
| Contact Type | primary | Contact Type | backup |
| Name | Mélanie PORTE | Name | Cloé LAFFARGUE |
| melanie.porte@chu-nimes.fr | cloe.laffargue@gmail.fr | ||
| Phone | +33466683459 | Phone | +33466683459 |
Conditions
| Sequence: | 52177361 |
| Name | Cerebral Palsy Infantile |
| Downcase Name | cerebral palsy infantile |
Id Information
| Sequence: | 40162931 | Sequence: | 40162932 |
| Id Source | org_study_id | Id Source | secondary_id |
| Id Value | Local/2022/CL-01 | Id Value | ANSM |
| Id Type | Other Identifier | ||
| Id Type Description | 2022-A01466-37 | ||
Countries
| Sequence: | 42573727 |
| Name | France |
| Removed | False |
Design Groups
| Sequence: | 55600043 |
| Title | Child with Cerebral Palsy |
| Description | 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) |
Interventions
| Sequence: | 52491472 |
| Intervention Type | Radiation |
| Name | spine and pelvis radiography |
| Description | 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. |
Keywords
| Sequence: | 79876467 | Sequence: | 79876468 | Sequence: | 79876469 | Sequence: | 79876470 | Sequence: | 79876471 | Sequence: | 79876472 | Sequence: | 79876473 |
| Name | Spine | Name | Child | Name | Adolescent | Name | Pelvis | Name | Postural Balance | Name | Posture | Name | Radiography |
| Downcase Name | spine | Downcase Name | child | Downcase Name | adolescent | Downcase Name | pelvis | Downcase Name | postural balance | Downcase Name | posture | Downcase Name | radiography |
Design Outcomes
| Sequence: | 177403464 | Sequence: | 177403465 | Sequence: | 177403466 | Sequence: | 177403467 | Sequence: | 177403468 | Sequence: | 177403469 | Sequence: | 177403470 |
| Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary |
| Measure | Evolution of the sagittal spinal statics in the sitting position | Measure | Evolution of the sagittal spinal statics in the sitting position | Measure | Evolution of the sagittal spinal statics in the sitting position | Measure | Evolution of the sagittal spinal statics in the sitting position | Measure | Evolution of the sagittal spinal statics in the sitting position | Measure | Evolution of the sagittal spinal statics in the sitting position | Measure | Evolution of the sagittal spinal statics in the sitting position |
| Time Frame | At baseline | Time Frame | At baseline | Time Frame | At baseline | Time Frame | At baseline | Time Frame | At baseline | Time Frame | At baseline | Time Frame | At baseline |
| Description | measurement of pelvic incidence (normal values between 35 and 85 degrees) | Description | sacral slope (angle of inclination of the sacral plateau in profile to the horizontal (degrees)) | Description | 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)) | Description | lordoses cervicales (in degrees) | Description | lumbar lordosis (in degrees) | Description | thoracic kyphosis (in degrees) | Description | 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.) |
Browse Conditions
| Sequence: | 193509841 | Sequence: | 193509842 | Sequence: | 193509843 | Sequence: | 193509844 | Sequence: | 193509845 |
| Mesh Term | Cerebral Palsy | Mesh Term | Nervous System Diseases | Mesh Term | Brain Damage, Chronic | Mesh Term | Brain Diseases | Mesh Term | Central Nervous System Diseases |
| Downcase Mesh Term | cerebral palsy | Downcase Mesh Term | nervous system diseases | Downcase Mesh Term | brain damage, chronic | Downcase Mesh Term | brain diseases | Downcase Mesh Term | central nervous system diseases |
| Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48324719 |
| Agency Class | OTHER |
| Lead Or Collaborator | lead |
| Name | Centre Hospitalier Universitaire de Nīmes |
Overall Officials
| Sequence: | 29288330 |
| Role | Study Director |
| Name | Anissa MEGZARI |
| Affiliation | Centre Hospitalier Universitaire de Nīmes |
Central Contacts
| Sequence: | 12010563 | Sequence: | 12010564 |
| Contact Type | primary | Contact Type | backup |
| Name | Mélanie PORTE | Name | Cloé LAFFARGUE |
| Phone | +33 4.66.68.34.59 | Phone | +33 4.66.68.34.59 |
| melanie.porte@chu-nimes.fr | cloe.laffargue@gmail.fr | ||
| Role | Contact | Role | Contact |
Design Group Interventions
| Sequence: | 68157539 |
| Design Group Id | 55600043 |
| Intervention Id | 52491472 |
Eligibilities
| Sequence: | 30768824 |
| Sampling Method | Probability Sample |
| Gender | All |
| Minimum Age | 4 Years |
| Maximum Age | 17 Years |
| Healthy Volunteers | No |
| 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 |
| Criteria | Inclusion Criteria: 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 Exclusion Criteria: 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 |
| Adult | False |
| Child | True |
| Older Adult | False |
Calculated Values
| Sequence: | 253931762 |
| Number Of Facilities | 1 |
| Registered In Calendar Year | 2022 |
| Were Results Reported | False |
| Has Us Facility | False |
| Has Single Facility | True |
| Minimum Age Num | 4 |
| Maximum Age Num | 17 |
| Minimum Age Unit | Years |
| Maximum Age Unit | Years |
| Number Of Primary Outcomes To Measure | 7 |
Designs
| Sequence: | 30514983 |
| Observational Model | Cohort |
| Time Perspective | Prospective |
Responsible Parties
| Sequence: | 28881287 |
| Responsible Party Type | Sponsor |