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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
Sponsor
Phase
Observational
Started
2023-11-16
Last updated
2026-09-10

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

FacilityCityRegionStatus
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
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