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

Recruiting
18 years of age
Both
Phase N/A

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Overview

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);

  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.

Exclusion Criteria:

  1. Contraindication to BoNT-A treatment;
  2. Previously treated with BoNT-A in upper limbs within the last 12 months;
  3. Patients 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 patients hospitalized for injection (maximum 48 hours) and day hospitalizations;
  8. Vulnerable patients (i.e. pregnant and/or lactating women, children, patient under curatorship or deprived of liberty).

Study details

Upper Limb Injury

NCT06245772

Ipsen

8 June 2024

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