Informations générales (source: ClinicalTrials.gov)
A National, Multicentre, Non-interventional, Prospective, Longitudinal Study to Assess CARegiver BURden, Effectiveness and Other Health Care Measures on Functional Disability, in Patients Treated With Abobotulinumtoxin A for Upper Limb Spasticity in Routine Clinical Practice. (CARBUR)
Observational
Ipsen (Voir sur ClinicalTrials)
novembre 2023
septembre 2026
24 juin 2025
The aim of this study is to perform, in real world clinical practice, a three-dimensional
assessment from patient's, caregiver's and physician's perspectives, of the impact of
AboBoNT-A on caregiver burden, functional disability and other health care measures in
patients affected with ULS due to acquired brain injuries.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CENTRE HOSPITALIER DE GONESSE | Contact (sur clinicalTrials) | ||||
| GHU PARIS PSY ET NEUROSCIENCES | Contact (sur clinicalTrials) | ||||
| HOPITAL FONDATION A. DE ROTHSCHILD | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Besançon - CHU/CRRF de Bréguille/Salin les bains - 25030 - Besançon - France | Contact (sur clinicalTrials) | ||||
| Centre de rééducation des 3 vallées - Corbie - France | Contact (sur clinicalTrials) | ||||
| CH Ariège Couserans Site de Rozès - Saint-Girons - France | Contact (sur clinicalTrials) | ||||
| CH Bagnères - 65201 - Bagnères-de-Bigorre - France | Contact (sur clinicalTrials) | ||||
| CH Bar le Duc - 55012 - Bar-le-Duc - France | Contact (sur clinicalTrials) | ||||
| CH Bourg en Bresse - 01012 - Bourg-en-Bresse - France | Contact (sur clinicalTrials) | ||||
| CH Colmar - 68024 - Colmar - France | Contact (sur clinicalTrials) | ||||
| CH Dax - 40107 - Dax - France | Contact (sur clinicalTrials) | ||||
| CH Saint Denis - 93205 - Saint-Denis - France | Contact (sur clinicalTrials) | ||||
| CH Saint Jean de Luz - 64502 - Saint-Jean-de-Luz - France | Contact (sur clinicalTrials) | ||||
| CH Troyes - 10000 - Troyes - France | Contact (sur clinicalTrials) | ||||
| CHU Amiens - 80054 - Salouël - France | Contact (sur clinicalTrials) | ||||
| CHU Bordeaux - Hopital Tastet-Girard - 33076 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| CHU Brest - 29609 - Brest - France | Contact (sur clinicalTrials) | ||||
| CHU Lille - 59000 - Lille - France | Contact (sur clinicalTrials) | ||||
| CHU Montpellier - 34295 - Montpellier - France | Contact (sur clinicalTrials) | ||||
| CHU Nice - 06202 - Nice - France | Contact (sur clinicalTrials) | ||||
| CHU Nîmes - 30029 - Nîmes - France | Contact (sur clinicalTrials) | ||||
| CHU Reims - 51092 - Reims - France | Contact (sur clinicalTrials) | ||||
| CHU Rennes - 35033 - Rennes - France | Contact (sur clinicalTrials) | ||||
| CHU Toulouse - 31059 - Toulouse - France | Contact (sur clinicalTrials) | ||||
| Clinique de Verdaich - Gaillac-Toulza - France | Contact (sur clinicalTrials) | ||||
| Clinique Saint Martin Sud - Marseille - France | Contact (sur clinicalTrials) | ||||
| Crf Bel Air - La Membrolle-sur-Choisille - France | Contact (sur clinicalTrials) | ||||
| CRF DIivio Dijon - 21000 - Dijon - France | Contact (sur clinicalTrials) | ||||
| Fondation hopale - Fouqière-lez-Lens - 62HEN - Fouquières-lès-Lens - France | Contact (sur clinicalTrials) | ||||
| Fondation Ildys - Roscoff - 29684 - Roscoff - France | Contact (sur clinicalTrials) | ||||
| Garches - 92380 - Garche - France | Contact (sur clinicalTrials) | ||||
| HCL - Renée Sabran - 83406 - Hyères - France | Contact (sur clinicalTrials) | ||||
| Hôpital Rothschild - 75012 - Paris - France | Contact (sur clinicalTrials) | ||||
| Le Centre Médical Germaine Revel - Saint-Maurice-sur-Dargoire - France | Contact (sur clinicalTrials) | ||||
| Pole St Hélier - 35043 - Rennes - France | Contact (sur clinicalTrials) | ||||
| SSR Tour de Gassies - 33523 - Bruges - France | Contact (sur clinicalTrials) | ||||
| SSR Val Rosay UGECAM - 69370 - Saint Didier au Mont d'Or - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
1. The patient is able to comply with the protocol;
2. Male and female patients who are at least 18 years old;
3. The patient is supported by an identified caregiver (family member or other nonpaid
adult
- if the patient has more than one caregiver, the main caregiver will be
selected) who provides daily supervision or direct assistance to the care
recipient;
4. The patient has been diagnosed with ULS due to non-progressive acquired brain
injuries (stroke, traumatic brain injury, surgical resection of non-progressive
tumours, other) or due to non-progressive spinal cord injury with stability of
spasticity of the upper limbs;
5. The decision to treat the patient with AboBoNT-A by the care provider will be made
prior to, and independently from the decision to enrol the patient in the
observational study;
6. The patient is covered by a healthcare insurance;
7. The cognitive and health status of the patient is compatible with the participation
to the study.
For Caregivers :
(8) The caregiver is able to comply with the protocol; (9) Male and female caregivers who
are at least 18 years old; (10) The cognitive and health status of the caregiver is
compatible with the participation to the study.
1. The patient is able to comply with the protocol;
2. Male and female patients who are at least 18 years old;
3. The patient is supported by an identified caregiver (family member or other nonpaid
adult
- if the patient has more than one caregiver, the main caregiver will be
selected) who provides daily supervision or direct assistance to the care
recipient;
4. The patient has been diagnosed with ULS due to non-progressive acquired brain
injuries (stroke, traumatic brain injury, surgical resection of non-progressive
tumours, other) or due to non-progressive spinal cord injury with stability of
spasticity of the upper limbs;
5. The decision to treat the patient with AboBoNT-A by the care provider will be made
prior to, and independently from the decision to enrol the patient in the
observational study;
6. The patient is covered by a healthcare insurance;
7. The cognitive and health status of the patient is compatible with the participation
to the study.
For Caregivers :
(8) The caregiver is able to comply with the protocol; (9) Male and female caregivers who
are at least 18 years old; (10) The cognitive and health status of the caregiver is
compatible with the participation to the study.
1. Contraindication to BoNT-A treatment;
2. Previously treated with BoNT-A in upper limbs within the last 12 months;
3. Patients and if applicable Legally Authorized Representative (LAR) of patient under
curatorship or deprived of liberty who are opposed to their data collection
4. Caregivers who are opposed to their data collection;
5. Caregivers already included for another patient;
6. Current participation in any other interventional clinical study or have
participated within the 12 weeks prior to the inclusion visit;
7. Non-ambulatory patients except for those who have been hospitalized for the purpose
of their BoNT-A injection (maximum length of stay as per clinical judgment of the
investigator);
8. Vulnerable patients (i.e. pregnant and/or lactating women, children, patient under
curatorship or deprived of liberty).