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

Ipsen113 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

113

Conditions

Upper Limb Injury

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (37)

Outcomes

Primary Outcomes

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.

Time frame: From baseline to 8 weeks

Secondary Outcomes

Patient's demographic data

Patient's Characteristics

Time frame: through study completion, an average of 14 months

Caregiver's demographic data;

Patient's Characteristics

Time frame: through study completion, an average of 14 months

Aetiology of spasticity;

Patient's Characteristics

Time frame: through study completion, an average of 14 months

Affected upper limb

Patient's Characteristics

Time frame: through study completion, an average of 14 months

Ascribed spastic muscle group(s);

Patient's Characteristics

Time frame: through study completion, an average of 14 months

Time since onset of the aetiology of upper limb spasticity (ULS)

Patient's Characteristics

Time frame: through study completion, an average of 14 months

Associated lower limb spasticity (LLS)

Patient's Characteristics

Time frame: through study completion, an average of 14 months

Central Contacts

Ipsen Clinical Study Enquiries

CONTACT

See e mail clinical.trials@ipsen.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

CH Bagnères

Bagnères-de-Bigorre, France

RECRUITING

CH Bar le Duc

Bar-le-Duc, France

RECRUITING

Besançon - CHU/CRRF de Bréguille/Salin les bains

Besançon, France

RECRUITING

CHU Bordeaux - Hopital Tastet-Girard

Bordeaux, France

RECRUITING

CH Bourg en Bresse

Bourg-en-Bresse, France

RECRUITING

CHU Brest

Brest, France

RECRUITING

SSR Tour de Gassies

Bruges, France

WITHDRAWN

CH Colmar

Colmar, France

WITHDRAWN

Centre de rééducation des 3 vallées

Corbie, France

NOT_YET_RECRUITING

CH Dax

Dax, France

RECRUITING

...and 27 more locations

Global autonomy evaluation (modified Rankin Scale).

Patient's Characteristics

Time frame: through study completion, an average of 14 months

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.

Time frame: through study completion, an average of 14 months

Dose per muscle group;

Injections Practices; over a period of 3 cycles of treatment with AboBoNT-A in patients affected with ULS.

Time frame: through study completion, an average of 14 months

Number of injected muscle group(s)

Injections Practices; over a period of 3 cycles of treatment with AboBoNT-A in patients affected with ULS.

Time frame: through study completion, an average of 14 months

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.

Time frame: through study completion, an average of 14 months

Time between two injections;

Injections Practices; over a period of 3 cycles of treatment with AboBoNT-A in patients affected with ULS.

Time frame: through study completion, an average of 14 months

Criteria for reinjection;

Injections Practices; over a period of 3 cycles of treatment with AboBoNT-A in patients affected with ULS.

Time frame: through study completion, an average of 14 months

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.

Time frame: through study completion, an average of 14 months

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

Time frame: through study completion, an average of 14 months

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

Time frame: through study completion, an average of 14 months

Goal score

Treatment Effectiveness; To assess goals achievement it will be used an adapted scale / Therapeutic Goal Attainment Scaling (TGAS) with pre-defined goals

Time frame: through study completion, an average of 14 months

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

Time frame: through study completion, an average of 14 months

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

Time frame: through study completion, an average of 26 months

Proportion of patients "attaining" the primary Goal

Treatment Effectiveness

Time frame: through study completion, an average of 14 months

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

Time frame: through study completion, an average of 14 months

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

Time frame: through study completion, an average of 14 months

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

Time frame: through study completion, an average of 14 months

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

Time frame: through study completion, an average of 14 months

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

Time frame: through study completion, an average of 14 months

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

Time frame: Up to 14 months

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

Time frame: Up to 14 months

Number and percentage of patients with concomitant surgical procedures impacting caregivers' burden and patients' health.

Concomitant Medications, Non-Drug Therapies and Surgeries

Time frame: Up to 14 months