All studies
Active not recruitingOBSERVATIONAL

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

This study aims to understand the full impact of a treatment called AboBoNT-A, a type of botulinum toxin, for stiffness in the arm (upper limb spasticity). This stiffness can happen after brain injuries like a stroke or head injury, or a spinal cord injury. Researchers want to see how this treatment affects not just the patient's ability to do daily tasks, but also the burden on their unpaid carer and other healthcare aspects. They will gather information from patients, carers, and doctors to get a complete picture. The goal is to see how this treatment works in real-life situations and improve the lives of those affected by arm spasticity.

At a glance

Status
Active not recruiting
Sponsor
Ipsen
Enrolment target
113
Start
16 Nov 2023
Estimated completion
28 Feb 2027

What is this study about?

This study is designed to explore how a specific treatment, called AboBoNT-A (a type of botulinum toxin, similar to Botox), helps people who have stiffness in their arm, known as upper limb spasticity. This stiffness often occurs after brain injuries like a stroke or head injury, or following a spinal cord injury. The researchers want to understand the effects of this treatment from several viewpoints:

Firstly, they want to see how the treatment affects the patient's ability to carry out everyday activities. Secondly, they're looking at the impact on the unpaid carer, often a family member, who helps the patient daily. Lastly, they aim to understand the broader healthcare effects. By gathering information from patients, their carers, and their doctors, the study hopes to build a complete picture of how AboBoNT-A works in real-world clinical settings, helping doctors make the best treatment decisions.

It's important to know that the decision to start treatment with AboBoNT-A is made by your doctor independently, before you even consider joining this study. This study simply observes what happens once that treatment decision is already in place. It's about learning more about the experiences of people undergoing this treatment and their carers, which could lead to better support and care in the future for others with similar conditions.

Key takeaways

  • Study looks at real-life effects of arm stiffness treatment (AboBoNT-A).
  • Focuses on patients after brain/spinal cord injuries.
  • Gathers information from patients, carers, and doctors.
  • Aims to understand impact on daily life and carer burden.
  • Your doctor decides your treatment independently of the study.
  • Participation helps improve future care for others.

Who may be eligible?

To be considered for this study, you must be at least 18 years old and have been diagnosed with stiffness in your arm (upper limb spasticity) due to a past brain injury (like a stroke or head injury) or a stable spinal cord injury. You also need an unpaid carer, who is at least 18 years old, to help you daily. Both you and your carer must be able to follow the study instructions, and your doctor must have already decided that AboBoNT-A treatment is right for you, regardless of your participation in this study.

There are also some reasons why you might not be able to join. For example, if you've had botulinum toxin treatment in your arm within the last 12 months, or if you have any medical reasons that prevent you from safely receiving this type of treatment. You also can't be taking part in another clinical study or have recently done so.

Both you and your carer must agree to have your information collected for the study. If your carer is already helping another person in this study, they won't be able to join again. The study also aims to include people who are generally well enough to participate and are covered by healthcare insurance.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you at least 18 years old?
  2. Do you have arm stiffness (spasticity) due to a brain or spinal cord injury?
  3. Do you have an adult (unpaid) carer who helps you daily?
  4. Has your doctor already decided you will receive AboBoNT-A treatment?
  5. Have you NOT had AboBoNT-A in your arm in the last 12 months?
  6. Are you able to follow study instructions?
Answer every question to see your result.

What does participation involve?

This study is an 'observational' study, meaning you won't be given a new or experimental treatment. Instead, researchers will collect information about your health and treatment with AboBoNT-A as part of your regular care, which your doctor has already decided is best for you. Participation will involve providing information from your perspective, your carer's perspective, and your doctor's perspective throughout your treatment course. The total duration of your participation will depend on your treatment plan, but it's largely about collecting data during your routine visits and discussions.

Potential risks and benefits

The main benefit of taking part is contributing to a better understanding of how AboBoNT-A treatment impacts patients with arm spasticity and their carers. This information could help improve care for many others in the future. Since this is an observational study, which means no new treatments are being tested, the risks are generally low. However, collecting information may take some of your time and your carer's time. You and your carer have the right to withdraw from the study at any time without affecting your medical care.

Locations (27)

  • CH Bagnères
    Verified postcode
    Bagnères-de-Bigorre, France
  • CH Bar le Duc
    Verified postcode
    Bar-le-Duc, France
  • Besançon - CHU/CRRF de Bréguille/Salin les bains
    Verified postcode
    Besançon, France
  • CHU Bordeaux - Hopital Tastet-Girard
    Verified postcode
    Bordeaux, France
  • CH Bourg en Bresse
    Verified postcode
    Bourg-en-Bresse, France
  • CHU Brest
    Verified postcode
    Brest, France
  • Centre de rééducation des 3 vallées
    Verified postcode
    Corbie, France
  • CH Dax
    Verified postcode
    Dax, France
  • Fondation hopale - Fouqière-lez-Lens
    Verified postcode
    Fouquières-lès-Lens, France
  • Clinique de Verdaich
    Verified postcode
    Gaillac-Toulza, France
  • HCL - Renée Sabran
    Verified postcode
    Hyères, France
  • Crf Bel Air
    Verified postcode
    La Membrolle-sur-Choisille, France

Common questions

What is 'upper limb spasticity'?

Upper limb spasticity is when muscles in your arm and hand become stiff and tight, making it hard to move them freely. It often happens after injuries to the brain or spinal cord.

What is AboBoNT-A?

AboBoNT-A is a medicine, often known as a type of botulinum toxin or Botox, used to relax stiff muscles. It's injected into the affected muscles to reduce spasticity.

Will I get free treatment if I join this study?

No, this study doesn't provide the AboBoNT-A treatment. Your doctor will have already decided to treat you with AboBoNT-A, and the study will observe the outcomes of that treatment.

What does being an 'unpaid caregiver' mean in this study?

An unpaid caregiver is an adult, often a family member or friend, who helps you daily with support or direct assistance and is not paid for this care.

Can I leave the study at any time?

Yes, you or your carer can decide to stop participating in the study at any point, and your decision will not affect your medical care or treatment.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.