Upper Limb Injury
Conditions
Brief 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.
Interventions
None listed
Sponsors
Ipsen
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the 5-item Carer Burden Scale (CBS) mean score | From baseline to 8 weeks | The 5-item Carer Burden Scale is 5-point Likert scale ranging from 0 (no difficulty) to 4 (cannot complete the task), so that higher scores indicate greater burden. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient's demographic data | through study completion, an average of 14 months | Patient's Characteristics |
| Caregiver's demographic data; | through study completion, an average of 14 months | Patient's Characteristics |
| Aetiology of spasticity; | through study completion, an average of 14 months | Patient's Characteristics |
| Affected upper limb | through study completion, an average of 14 months | Patient's Characteristics |
| Ascribed spastic muscle group(s); | through study completion, an average of 14 months | Patient's Characteristics |
| Time since onset of the aetiology of upper limb spasticity (ULS) | through study completion, an average of 14 months | Patient's Characteristics |
| Associated lower limb spasticity (LLS) | through study completion, an average of 14 months | Patient's Characteristics |
| Global autonomy evaluation (modified Rankin Scale). | through study completion, an average of 14 months | Patient's Characteristics |
| Total dose injected in ULS per cycle; | through study completion, an average of 14 months | Injections Practices; over a period of 3 cycles of treatment with AboBoNT-A in patients affected with ULS. |
| Dose per muscle group; | through study completion, an average of 14 months | Injections Practices; over a period of 3 cycles of treatment with AboBoNT-A in patients affected with ULS. |
| Number of injected muscle group(s) | through study completion, an average of 14 months | Injections Practices; over a period of 3 cycles of treatment with AboBoNT-A in patients affected with ULS. |
| Injections Practices - Total dose injected per cycle (any indication); | through study completion, an average of 14 months | Injections Practices; over a period of 3 cycles of treatment with AboBoNT-A in patients affected with ULS. |
| Time between two injections; | through study completion, an average of 14 months | Injections Practices; over a period of 3 cycles of treatment with AboBoNT-A in patients affected with ULS. |
| Criteria for reinjection; | through study completion, an average of 14 months | Injections Practices; over a period of 3 cycles of treatment with AboBoNT-A in patients affected with ULS. |
| Reasons for treatment discontinuation, if any, and subsequent therapy if any. | through study completion, an average of 14 months | Injections Practices; over a period of 3 cycles of treatment with AboBoNT-A in patients affected with ULS. |
| Change from baseline in Carer Burden Scale (CBS) | through study completion, an average of 14 months | Caregiver Burden; The impact of treatment on the physical burden of the caregiver will be assessed by the same caregiver using a modified paper version of the CBS self-administered questionnaire |
| Change from baseline in ZBI-12 total score to the end of each AboBoNT-A cycle | through study completion, an average of 14 months | Treatment Effectiveness; ZBI-12 is a self-administered questionnaire for measuring caregiving burden |
| Goal score | through study completion, an average of 14 months | Treatment Effectiveness; To assess goals achievement it will be used an adapted scale / Therapeutic Goal Attainment Scaling (TGAS) with pre-defined goals |
| Goal score change | through study completion, an average of 14 months | Treatment Effectiveness; To assess goals achievement it will be used an adapted scale / Therapeutic Goal Attainment Scaling (TGAS) with pre-defined goals |
| Distribution of Goals each AboBoNT-A cycle; | through study completion, an average of 26 months | Treatment Effectiveness; To assess goals achievement it will be used an adapted scale / Therapeutic Goal Attainment Scaling (TGAS) with pre-defined goals |
| Proportion of patients "attaining" the primary Goal | through study completion, an average of 14 months | Treatment Effectiveness |
| Proportion of patients "attaining" at least one Goal | through study completion, an average of 14 months | Treatment Effectiveness; To assess goals achievement it will be used an adapted scale / Therapeutic Goal Attainment Scaling (TGAS) with pre-defined goals |
| Proportion of patients "attaining" the pre-defined goal | through study completion, an average of 14 months | Treatment Effectiveness; To assess goals achievement it will be used an adapted scale / Therapeutic Goal Attainment Scaling (TGAS) with pre-defined goals |
| Change from baseline in Modified Ashworth Scale (MAS) score. | through study completion, an average of 14 months | Treatment Effectiveness; Based on routine clinical examination, group muscle tone assessments performed by the Investigator according to the MAS will be recorded |
| Change from baseline in SQoL-6D total score | through study completion, an average of 14 months | Patient's Spasticity-Related Health Status (PS-RHS); The SQoL-6D consists of a 6-dimensions self-administered questionnaire that provides an overall picture of ULS spasticity-related health status |
| Change from baseline in SQoL-6D pain/discomfort subscore | through study completion, an average of 14 months | Patient's Spasticity-Related Health Status (PS-RHS); The SQoL-6D consists of a 6-dimensions self-administered questionnaire that provides an overall picture of ULS spasticity-related health status |
| Number and percentage of patients with the following concomitant medications: oral antispasticity medications, pain medications (nociceptive and neuropathic pain), psychotropic drugs and anticoagulant drugs. | Up to 14 months | Concomitant Medications, Non-Drug Therapies and Surgeries |
| Number and percentage of patients with the following concomitant non-drug therapies for the management of ULS: physiotherapy and use of orthoses; | Up to 14 months | Concomitant Medications, Non-Drug Therapies and Surgeries |
| Number and percentage of patients with concomitant surgical procedures impacting caregivers' burden and patients' health. | Up to 14 months | Concomitant Medications, Non-Drug Therapies and Surgeries |
Countries
France
Contacts
STUDY_DIRECTORIpsen Medical Director
Ipsen
Outcome results
None listed