Clinical trial NCT06245772: CARegiver BURden, Effectiveness and Other Health Care Measures on Functional Disability, in Patients Treated With Abobotulinumtoxin A for Upper Limb Spasticity
Official 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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Upper Limb Injury
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2024-02-07
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with ULS who will start AboBoNT-A treatment in upper limbs as part of routine clinical practice should be recruited. Patients who received BoNT-A injections in upper limbs less than one year prior to inclusion should not be included in the study. Patients who previously received BoNTA injections in body parts other than upper limbs could be included in the study, regardless of injection anteriority.

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.


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).

Primary outcomes:
measure: Change from baseline in the 5-item Carer Burden Scale (CBS) mean score
timeFrame: From baseline to 8 weeks
Secondary outcomes:
measure: Patient's demographic data
timeFrame: through study completion, an average of 14 months
measure: Caregiver's demographic data;
timeFrame: through study completion, an average of 14 months
measure: Aetiology of spasticity;
timeFrame: through study completion, an average of 14 months
measure: Affected upper limb
timeFrame: through study completion, an average of 14 months
measure: Ascribed spastic muscle group(s);
timeFrame: through study completion, an average of 14 months
measure: Time since onset of the aetiology of upper limb spasticity (ULS)
timeFrame: through study completion, an average of 14 months
measure: Associated lower limb spasticity (LLS)
timeFrame: through study completion, an average of 14 months
measure: Global autonomy evaluation (modified Rankin Scale).
timeFrame: through study completion, an average of 14 months
measure: Total dose injected in ULS per cycle;
timeFrame: through study completion, an average of 14 months
measure: Dose per muscle group;
timeFrame: through study completion, an average of 14 months
measure: Number of injected muscle group(s)
timeFrame: through study completion, an average of 14 months
measure: Injections Practices - Total dose injected per cycle (any indication);
timeFrame: through study completion, an average of 14 months
measure: Time between two injections;
timeFrame: through study completion, an average of 14 months
measure: Criteria for reinjection;
timeFrame: through study completion, an average of 14 months
measure: Reasons for treatment discontinuation, if any, and subsequent therapy if any.
timeFrame: through study completion, an average of 14 months
measure: Change from baseline in Carer Burden Scale (CBS)
timeFrame: through study completion, an average of 14 months
measure: Change from baseline in ZBI-12 total score to the end of each AboBoNT-A cycle
timeFrame: through study completion, an average of 14 months
measure: Goal score
timeFrame: through study completion, an average of 14 months
measure: Goal score change
timeFrame: through study completion, an average of 14 months
measure: Distribution of Goals each AboBoNT-A cycle;
timeFrame: through study completion, an average of 26 months
measure: Proportion of patients "attaining" the primary Goal
timeFrame: through study completion, an average of 14 months
measure: Proportion of patients "attaining" at least one Goal
timeFrame: through study completion, an average of 14 months
measure: Proportion of patients "attaining" the pre-defined goal
timeFrame: through study completion, an average of 14 months
measure: Change from baseline in Modified Ashworth Scale (MAS) score.
timeFrame: through study completion, an average of 14 months
measure: Change from baseline in SQoL-6D total score
timeFrame: through study completion, an average of 14 months
measure: Change from baseline in SQoL-6D pain/discomfort subscore
timeFrame: through study completion, an average of 14 months
measure: Number and percentage of patients with the following concomitant medications: oral antispasticity medications, pain medications (nociceptive and neuropathic pain), psychotropic drugs and anticoagulant drugs.
timeFrame: Up to 14 months
measure: Number and percentage of patients with the following concomitant non-drug therapies for the management of ULS: physiotherapy and use of orthoses;
timeFrame: Up to 14 months
measure: Number and percentage of patients with concomitant surgical procedures impacting caregivers' burden and patients' health.
timeFrame: Up to 14 months
Other outcomes:
Locations:
city: Bagnères-de-Bigorre
country: France
facility: CH Bagnères
city: Bar-le-Duc
country: France
facility: CH Bar le Duc
city: Besançon
country: France
facility: Besançon - CHU/CRRF de Bréguille/Salin les bains
city: Bordeaux
country: France
facility: CHU Bordeaux - Hopital Tastet-Girard
city: Bourg-en-Bresse
country: France
facility: CH Bourg en Bresse
city: Brest
country: France
facility: CHU Brest
city: Bruges
country: France
facility: SSR Tour de Gassies
city: Colmar
country: France
facility: CH Colmar
city: Corbie
country: France
facility: Centre de rééducation des 3 vallées
city: Dax
country: France
facility: CH Dax
city: Dijon
country: France
facility: CRF DIivio Dijon
city: Fouquières-lès-Lens
country: France
facility: Fondation hopale - Fouqière-lez-Lens
city: Gaillac-Toulza
country: France
facility: Clinique de Verdaich
city: Garche
country: France
facility: Garches
city: Gonesse
country: France
facility: Groupe Hospitalier De Gonesse
city: Hyères
country: France
facility: HCL - Renée Sabran
city: La Membrolle-sur-Choisille
country: France
facility: Crf Bel Air
city: Lille
country: France
facility: CHU Lille
city: Marseille
country: France
facility: Clinique Saint Martin Sud
city: Montpellier
country: France
facility: CHU Montpellier
city: Nice
country: France
facility: CHU Nice
city: Nîmes
country: France
facility: CHU Nîmes
city: Paris
country: France
facility: Hôpital Rothschild
city: Paris
country: France
facility: Ste Anne
city: Paris
country: France
facility: Hôpital Fondation Adolphe de Rothschild
city: Reims
country: France
facility: CHU Reims
city: Rennes
country: France
facility: CHU Rennes
city: Rennes
country: France
facility: Pole St Hélier
city: Roscoff
country: France
facility: Fondation Ildys - Roscoff
city: Saint Didier au Mont d'Or
country: France
facility: SSR Val Rosay UGECAM
city: Saint-Denis
country: France
facility: CH Saint Denis
city: Saint-Girons
country: France
facility: CH Ariège Couserans Site de Rozès
city: Saint-Jean-de-Luz
country: France
facility: CH Saint Jean de Luz
city: Saint-Maurice-sur-Dargoire
country: France
facility: Le Centre Médical Germaine Revel
city: Salouël
country: France
facility: CHU Amiens
city: Toulouse
country: France
facility: CHU Toulouse
city: Troyes
country: France
facility: CH Troyes
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: