Upper Limb Injury Clinical Trial
— CARBUROfficial title:
A National, Multicentre, Non-interventional, Prospective, Longitudinal Study to Assess CARegiver BURden, Effectiveness and Other Health Care Measures on Functional Disability, in Patients Treated With Abobotulinumtoxin A for Upper Limb Spasticity in Routine Clinical Practice.
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.
Status | Recruiting |
Enrollment | 133 |
Est. completion date | January 16, 2026 |
Est. primary completion date | January 16, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
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). |
Country | Name | City | State |
---|---|---|---|
France | CH Bagnères | Bagnères-de-Bigorre | |
France | CH Bar le Duc | Bar-le-Duc | |
France | Besançon - CHU/CRRF de Bréguille/Salin les bains | Besançon | |
France | CHU Bordeaux - Hopital Tastet-Girard | Bordeaux | |
France | CH Bourg en Bresse | Bourg-en-Bresse | |
France | CHU Brest | Brest | |
France | SSR Tour de Gassies | Bruges | |
France | CH Colmar | Colmar | |
France | CH Dax | Dax | |
France | CRF DIivio Dijon | Dijon | |
France | Fondation hopale - Fouqière-lez-Lens | Fouquières-lès-Lens | |
France | Garches | Garche | |
France | Groupe Hospitalier De Gonesse | Gonesse | |
France | HCL - Renée Sabran | Hyères | |
France | CHU Lille | Lille | |
France | Clinique Saint Martin Sud | Marseille | |
France | Clinique Saint-Martin Sud | Marseille | |
France | CHU Montpellier | Montpellier | |
France | CHU Nice | Nice | |
France | CHU Nîmes | Nîmes | |
France | Hôpital Rothschild | Paris | |
France | Ste Anne | Paris | |
France | CHU Reims | Reims | |
France | CHU Rennes | Rennes | |
France | Pole St Hélier | Rennes | |
France | Fondation Ildys - Roscoff | Roscoff | |
France | SSR Val Rosay UGECAM | Saint Didier au Mont d'Or | |
France | CH Saint Denis | Saint-Denis | |
France | CH Saint Jean de Luz | Saint-Jean-de-Luz | |
France | CHU Amiens | Salouël | |
France | CHU Toulouse | Toulouse | |
France | CH Troyes | Troyes |
Lead Sponsor | Collaborator |
---|---|
Ipsen |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in the 5-item Carer Burden Scale (CBS) mean score | 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. | through study completion, an average of 26 months | |
Secondary | Patient's demographic data | Patient's Characteristics | through study completion, an average of 26 months | |
Secondary | Caregiver's demographic data; | Patient's Characteristics | through study completion, an average of 26 months | |
Secondary | Aetiology of spasticity; | Patient's Characteristics | through study completion, an average of 26 months | |
Secondary | Affected upper limb | Patient's Characteristics | through study completion, an average of 26 months | |
Secondary | Ascribed spastic muscle group(s); | Patient's Characteristics | through study completion, an average of 26 months | |
Secondary | Time since onset of the aetiology of upper limb spasticity (ULS) | Patient's Characteristics | through study completion, an average of 26 months | |
Secondary | Associated lower limb spasticity (LLS) | Patient's Characteristics | through study completion, an average of 26 months | |
Secondary | Global autonomy evaluation (modified Rankin Scale). | Patient's Characteristics | through study completion, an average of 26 months | |
Secondary | Total dose injected in ULS per cycle; | Injections Practices; over a period of 3 cycles of treatment with AboBoNT-A in patients affected with ULS. | through study completion, an average of 26 months | |
Secondary | Dose per muscle group; | Injections Practices; over a period of 3 cycles of treatment with AboBoNT-A in patients affected with ULS. | through study completion, an average of 26 months | |
Secondary | Number of injected muscle group(s) | Injections Practices; over a period of 3 cycles of treatment with AboBoNT-A in patients affected with ULS. | through study completion, an average of 26 months | |
Secondary | Injections Practices - Total dose injected per cycle (any indication); | Injections Practices; over a period of 3 cycles of treatment with AboBoNT-A in patients affected with ULS. | through study completion, an average of 26 months | |
Secondary | Time between two injections; | Injections Practices; over a period of 3 cycles of treatment with AboBoNT-A in patients affected with ULS. | through study completion, an average of 26 months | |
Secondary | Criteria for reinjection; | Injections Practices; over a period of 3 cycles of treatment with AboBoNT-A in patients affected with ULS. | through study completion, an average of 26 months | |
Secondary | Reasons for treatment discontinuation, if any, and subsequent therapy if any. | Injections Practices; over a period of 3 cycles of treatment with AboBoNT-A in patients affected with ULS. | through study completion, an average of 26 months | |
Secondary | Change from baseline in Carer Burden Scale (CBS) | 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 | through study completion, an average of 26 months | |
Secondary | Change from baseline in ZBI-12 total score to the end of each AboBoNT-A cycle | Treatment Effectiveness; ZBI-12 is a self-administered questionnaire for measuring caregiving burden | through study completion, an average of 26 months | |
Secondary | Goal score | Treatment Effectiveness; To assess goals achievement it will be used an adapted scale / Therapeutic Goal Attainment Scaling (TGAS) with pre-defined goals | through study completion, an average of 26 months | |
Secondary | Goal score change | Treatment Effectiveness; To assess goals achievement it will be used an adapted scale / Therapeutic Goal Attainment Scaling (TGAS) with pre-defined goals | through study completion, an average of 26 months | |
Secondary | Distribution of Goals each AboBoNT-A cycle; | Treatment Effectiveness; To assess goals achievement it will be used an adapted scale / Therapeutic Goal Attainment Scaling (TGAS) with pre-defined goals | through study completion, an average of 26 months | |
Secondary | Proportion of patients "attaining" the primary Goal | Treatment Effectiveness | through study completion, an average of 26 months | |
Secondary | Proportion of patients "attaining" at least one Goal | Treatment Effectiveness; To assess goals achievement it will be used an adapted scale / Therapeutic Goal Attainment Scaling (TGAS) with pre-defined goals | through study completion, an average of 26 months | |
Secondary | Proportion of patients "attaining" the pre-defined goal | Treatment Effectiveness; To assess goals achievement it will be used an adapted scale / Therapeutic Goal Attainment Scaling (TGAS) with pre-defined goals | through study completion, an average of 26 months | |
Secondary | Change from baseline in Modified Ashworth Scale (MAS) score. | Treatment Effectiveness; Based on routine clinical examination, group muscle tone assessments performed by the Investigator according to the MAS will be recorded | through study completion, an average of 26 months | |
Secondary | Change from baseline in SQoL-6D total score | 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 | through study completion, an average of 26 months | |
Secondary | Change from baseline in SQoL-6D pain/discomfort subscore | 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 | through study completion, an average of 26 months | |
Secondary | Number and percentage of patients with the following concomitant medications: oral antispasticity medications, pain medications (nociceptive and neuropathic pain), psychotropic drugs and anticoagulant drugs. | Concomitant Medications, Non-Drug Therapies and Surgeries | Up to 26 months | |
Secondary | Number and percentage of patients with the following concomitant non-drug therapies for the management of ULS: physiotherapy and use of orthoses; | Concomitant Medications, Non-Drug Therapies and Surgeries | Up to 26 months | |
Secondary | Number and percentage of patients with concomitant surgical procedures impacting caregivers' burden and patients' health. | Concomitant Medications, Non-Drug Therapies and Surgeries | Up to 26 months |
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