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NCT Number: NCT06245772

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Upper Limb Injury Arm Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CH Bagnères, Bagnères-de-Bigorre, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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;
  • 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.

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

  • 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;
  • 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).

Treatment and study plan

Primary outcomes

  1. Change from baseline in the 5-item Carer Burden Scale (CBS) mean score

    Time frame: 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 outcomes

  1. Patient's demographic data

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

    Patient's Characteristics

  2. Caregiver's demographic data;

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

    Patient's Characteristics

  3. Aetiology of spasticity;

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

    Patient's Characteristics

  4. Affected upper limb

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

    Patient's Characteristics

  5. Ascribed spastic muscle group(s);

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

    Patient's Characteristics

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

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

    Patient's Characteristics

  7. Associated lower limb spasticity (LLS)

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

    Patient's Characteristics

  8. Global autonomy evaluation (modified Rankin Scale).

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

    Patient's Characteristics

  9. Total dose injected in ULS per cycle;

    Time frame: 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.

  10. Dose per muscle group;

    Time frame: 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.

  11. Number of injected muscle group(s)

    Time frame: 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.

  12. Injections Practices - Total dose injected per cycle (any indication);

    Time frame: 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.

  13. Time between two injections;

    Time frame: 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.

  14. Criteria for reinjection;

    Time frame: 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.

  15. Reasons for treatment discontinuation, if any, and subsequent therapy if any.

    Time frame: 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.

  16. Change from baseline in Carer Burden Scale (CBS)

    Time frame: 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

  17. Change from baseline in ZBI-12 total score to the end of each AboBoNT-A cycle

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

    Treatment Effectiveness; ZBI-12 is a self-administered questionnaire for measuring caregiving burden

  18. Goal score

    Time frame: 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

  19. Goal score change

    Time frame: 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

  20. Distribution of Goals each AboBoNT-A cycle;

    Time frame: 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

  21. Proportion of patients "attaining" the primary Goal

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

    Treatment Effectiveness

  22. Proportion of patients "attaining" at least one Goal

    Time frame: 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

  23. Proportion of patients "attaining" the pre-defined goal

    Time frame: 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

  24. Change from baseline in Modified Ashworth Scale (MAS) score.

    Time frame: 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

  25. Change from baseline in SQoL-6D total score

    Time frame: 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

  26. Change from baseline in SQoL-6D pain/discomfort subscore

    Time frame: 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

  27. Number and percentage of patients with the following concomitant medications: oral antispasticity medications, pain medications (nociceptive and neuropathic pain), psychotropic drugs and anticoagulant drugs.

    Time frame: Up to 14 months

    Concomitant Medications, Non-Drug Therapies and Surgeries

  28. Number and percentage of patients with the following concomitant non-drug therapies for the management of ULS: physiotherapy and use of orthoses;

    Time frame: Up to 14 months

    Concomitant Medications, Non-Drug Therapies and Surgeries

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

    Time frame: Up to 14 months

    Concomitant Medications, Non-Drug Therapies and Surgeries

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study 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.

Acronym: CARBUR

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Feb 7, 2024
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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