CARegiver BURden, Effectiveness and Other Health Care Measures on Functional Disability, in Patie… (NCT06245772) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
CARegiver BURden, Effectiveness and Other Health Care Measures on Functional Disability, in Patients Treated With Abobotulinumtoxin A for Upper Limb Spasticity
France113 participantsStarted 2023-11-16
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. The patient is able to comply with the protocol;
✓. Male and female patients who are at least 18 years old;
✓. The patient is supported by an identified caregiver (family member or other nonpaid adult
✓. 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;
✓. 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;
✓. The patient is covered by a healthcare insurance;
✓. The cognitive and health status of the patient is compatible with the participation to the study.
Exclusion criteria
✕. Contraindication to BoNT-A treatment;
✕. Previously treated with BoNT-A in upper limbs within the last 12 months;
✕. Patients and if applicable Legally Authorized Representative (LAR) of patient under curatorship or deprived of liberty who are opposed to their data collection
✕. Caregivers who are opposed to their data collection;
✕
What they're measuring
1
Change from baseline in the 5-item Carer Burden Scale (CBS) mean score
. Caregivers already included for another patient;
✕. Current participation in any other interventional clinical study or have participated within the 12 weeks prior to the inclusion visit;
✕. 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);
✕. Vulnerable patients (i.e. pregnant and/or lactating women, children, patient under curatorship or deprived of liberty).