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

Ipsen

Status: Enrolling

Conditions: Upper Limb Injury

Study type: Observational

Funder types: Industry

Identifiers

NCT06245772

CLIN-52120-459

Details and patient eligibility

About

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.

Enrollment: 113 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).