Clinical Trials in France / NCT06245772
Active, not recruiting
Observational
CARegiver BURden, Effectiveness and Other Health Care Measures on Functional Disability, in Patients Treated With Abobotulinumtoxin A for Upper Limb Spasticity
NCT06245772 · tracked via the Priya Life Science France tracker
Condition(s) studied
Upper Limb Injury
Study summary
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.
Eligibility
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.
Exclusion Criteria:
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).
Primary outcome measure(s)
- Change from baseline in the 5-item Carer Burden Scale (CBS) mean score — From baseline to 8 weeks
The 5-item Carer Burden Scale is 5-point Likert scale ranging from 0 (no difficulty) to 4 (cannot complete the task), so that higher scores indicate greater burden.
Trial sites (27)
| Facility | City | Region | Status |
|---|---|---|---|
| CH Bagnères | Bagnères-de-Bigorre | France | |
| CH Bar le Duc | Bar-le-Duc | France | |
| Besançon - CHU/CRRF de Bréguille/Salin les bains | Besançon | France | |
| CHU Bordeaux - Hopital Tastet-Girard | Bordeaux | France | |
| CH Bourg en Bresse | Bourg-en-Bresse | France | |
| CHU Brest | Brest | France | |
| Centre de rééducation des 3 vallées | Corbie | France | |
| CH Dax | Dax | France | |
| Fondation hopale - Fouqière-lez-Lens | Fouquières-lès-Lens | France | |
| Clinique de Verdaich | Gaillac-Toulza | France | |
| HCL - Renée Sabran | Hyères | France | |
| Crf Bel Air | La Membrolle-sur-Choisille | France | |
| CHU Lille | Lille | France | |
| CHU Nice | Nice | France | |
| CHU Nîmes | Nîmes | France | |
| Hôpital Rothschild | Paris | France | |
| Ste Anne | Paris | France | |
| Hôpital Fondation Adolphe de Rothschild | Paris | France | |
| CHU Reims | Reims | France | |
| CHU Rennes | Rennes | France | |
| Pole St Hélier | Rennes | France | |
| Fondation Ildys - Roscoff | Roscoff | France | |
| SSR Val Rosay UGECAM | Saint-Didier-au-Mont-d'Or | France | |
| CH Ariège Couserans Site de Rozès | Saint-Girons | France | |
| CH Saint Jean de Luz | Saint-Jean-de-Luz | France | |
| CHU Toulouse | Toulouse | France | |
| CH Troyes | Troyes | France |
More Ipsen trials in France
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06245772 on ClinicalTrials.gov ↗ ← All trials in France