CARegiver BURden, Effectiveness and Other Health Care Measures on Functional Disability, in Patients Treated With Abobotulinumtoxin A for Upper Limb Spasticity
NCT ID: NCT06245772
Last Updated: 2026-01-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
113 participants
OBSERVATIONAL
2023-11-16
2027-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
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
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).
18 Years
ALL
No
Sponsors
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Ipsen
INDUSTRY
Responsible Party
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Principal Investigators
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Ipsen Medical Director
Role: STUDY_DIRECTOR
Ipsen
Locations
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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
SSR Tour de Gassies
Bruges, , France
CH Colmar
Colmar, , France
Centre de rééducation des 3 vallées
Corbie, , France
CH Dax
Dax, , France
CRF DIivio Dijon
Dijon, , France
Fondation hopale - Fouqière-lez-Lens
Fouquières-lès-Lens, , France
Clinique de Verdaich
Gaillac-Toulza, , France
Garches
Garche, , France
Groupe Hospitalier De Gonesse
Gonesse, , France
HCL - Renée Sabran
Hyères, , France
Crf Bel Air
La Membrolle-sur-Choisille, , France
CHU Lille
Lille, , France
Clinique Saint Martin Sud
Marseille, , France
CHU Montpellier
Montpellier, , 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
CH Saint Denis
Saint-Denis, , 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
Le Centre Médical Germaine Revel
Saint-Maurice-sur-Dargoire, , France
CHU Amiens
Salouël, , France
CHU Toulouse
Toulouse, , France
CH Troyes
Troyes, , France
Countries
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Central Contacts
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Other Identifiers
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CLIN-52120-459
Identifier Type: -
Identifier Source: org_study_id
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