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

Launched by IPSEN · Jan 30, 2024

Keywords

ClinConnect Summary

The CARegiver BURden study is investigating how a treatment called Abobotulinumtoxin A (often referred to as AboBoNT-A) affects both patients with upper limb spasticity due to brain injuries and their caregivers. The goal is to understand how this treatment impacts the daily lives of patients and the burdens faced by those who care for them. Researchers will gather insights from patients, their caregivers, and doctors to see how effective the treatment is and how it influences overall health care needs.

To participate in this study, patients must be at least 18 years old and have a diagnosed upper limb condition caused by a non-progressive brain injury, such as a stroke or traumatic brain injury. They should have a caregiver who helps them daily and be covered by healthcare insurance. Participants can expect to share their experiences and health information throughout the study, which aims to provide a better understanding of both patient and caregiver perspectives on treatment outcomes. It's important to note that certain individuals, such as those who have had specific treatments recently or are part of other studies, may not be eligible to join.

Gender

ALL

Eligibility criteria

• 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).