CARegiver BURden, Effectiveness and Other Health Care Measures on Functional Disability, in Patients Treated With Abobotulinumtoxin A for Upper Limb Spasticity

Last updated: May 27, 2025
Sponsor: Ipsen
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT06245772
CLIN-52120-459
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

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 nonpaidadult

  • if the patient has more than one caregiver, the main caregiver will beselected) who provides daily supervision or direct assistance to the carerecipient;
  1. The patient has been diagnosed with ULS due to non-progressive acquired braininjuries (stroke, traumatic brain injury, surgical resection of non-progressivetumours, other) or due to non-progressive spinal cord injury with stability ofspasticity of the upper limbs;

  2. The decision to treat the patient with AboBoNT-A by the care provider will be madeprior to, and independently from the decision to enrol the patient in theobservational study;

  3. The patient is covered by a healthcare insurance;

  4. The cognitive and health status of the patient is compatible with the participationto 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

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 undercuratorship 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 haveparticipated within the 12 weeks prior to the inclusion visit;

  7. Non-ambulatory patients except for those who have been hospitalized for the purposeof their BoNT-A injection (maximum length of stay as per clinical judgment of theinvestigator);

  8. Vulnerable patients (i.e. pregnant and/or lactating women, children, patient undercuratorship or deprived of liberty).

Study Design

Total Participants: 113
Study Start date:
November 16, 2023
Estimated Completion Date:
September 30, 2026

Connect with a study center

  • CH Bagnères

    Bagnères-de-Bigorre, 65201
    France

    Active - Recruiting

  • CH Bar le Duc

    Bar-le-Duc, 55012
    France

    Active - Recruiting

  • Besançon - CHU/CRRF de Bréguille/Salin les bains

    Besançon, 25030
    France

    Site Not Available

  • CHU Bordeaux - Hopital Tastet-Girard

    Bordeaux, 33076
    France

    Active - Recruiting

  • CH Bourg en Bresse

    Bourg-en-Bresse, 01012
    France

    Active - Recruiting

  • CHU Brest

    Brest, 29609
    France

    Active - Recruiting

  • SSR Tour de Gassies

    Bruges, 33523
    France

    Site Not Available

  • CH Colmar

    Colmar, 68024
    France

    Site Not Available

  • Centre de rééducation des 3 vallées

    Corbie,
    France

    Site Not Available

  • CH Dax

    Dax, 40107
    France

    Active - Recruiting

  • CRF DIivio Dijon

    Dijon, 21000
    France

    Site Not Available

  • Fondation hopale - Fouqière-lez-Lens

    Fouquières-lès-Lens, 62HEN
    France

    Active - Recruiting

  • Clinique de Verdaich

    Gaillac-Toulza,
    France

    Site Not Available

  • Garches

    Garche, 92380
    France

    Site Not Available

  • Groupe Hospitalier De Gonesse

    Gonesse, 95503
    France

    Site Not Available

  • HCL - Renée Sabran

    Hyères, 83406
    France

    Active - Recruiting

  • Centre de Médecine physique

    La Membrolle-sur-Choisille,
    France

    Site Not Available

  • Crf Bel Air

    La Membrolle-sur-Choisille,
    France

    Active - Recruiting

  • CHU Lille

    Lille, 59000
    France

    Active - Recruiting

  • Clinique Saint Martin Sud

    Marseille,
    France

    Site Not Available

  • Clinique Saint-Martin Sud

    Marseille, 13009
    France

    Active - Recruiting

  • CHU Montpellier

    Montpellier, 34295
    France

    Site Not Available

  • CHU Nice

    Nice, 06202
    France

    Active - Recruiting

  • CHU Nîmes

    Nîmes, 30029
    France

    Site Not Available

  • Hôpital Fondation Adolphe de Rothschild

    Paris,
    France

    Site Not Available

  • Hôpital Rothschild

    Paris, 75012
    France

    Active - Recruiting

  • Ste Anne

    Paris, 75674
    France

    Active - Recruiting

  • CHU Reims

    Reims, 51092
    France

    Active - Recruiting

  • CHU Rennes

    Rennes, 35033
    France

    Active - Recruiting

  • Pole St Hélier

    Rennes, 35043
    France

    Active - Recruiting

  • Fondation Ildys - Roscoff

    Roscoff, 29684
    France

    Site Not Available

  • SSR Val Rosay UGECAM

    Saint Didier au Mont d'Or, 69370
    France

    Active - Recruiting

  • CH Saint Denis

    Saint-Denis, 93205
    France

    Site Not Available

  • CH Ariège Couserans Site de Rozès

    Saint-Girons,
    France

    Site Not Available

  • CH Saint Jean de Luz

    Saint-Jean-de-Luz, 64502
    France

    Active - Recruiting

  • Le Centre Médical Germaine Revel

    Saint-Maurice-sur-Dargoire,
    France

    Site Not Available

  • CHU Amiens

    Salouël, 80054
    France

    Site Not Available

  • CHU Toulouse

    Toulouse, 31059
    France

    Active - Recruiting

  • CH Troyes

    Troyes, 10000
    France

    Active - Recruiting

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