SURGERY VS BOTULINUM TOXIN ON QUALITY OF LIFE IN STROKE PATIENTS: RANDOMIZED TRIAL

Launched by FUNDACIÓN PÚBLICA ANDALUZA PARA LA INVESTIGACIÓN BIOMÉDICA ANDALUCÍA ORIENTAL · Apr 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether surgery can help improve the quality of life for stroke patients who have stiffness in their arms, known as spasticity. The researchers want to see if surgical treatment is a better option compared to the usual treatment, which includes injections of botulinum toxin (a substance that helps relax muscles) and therapy. They hope that by showing the benefits of surgery, it might become a more common treatment choice for these patients.

To participate in the trial, you need to be an adult who has had spasticity in your upper limb for at least a year after a stroke. It's important that you understand the study and agree to participate by signing a consent form. If you decide to join, you will be closely monitored for a year to see how the surgery or botulinum toxin treatment affects your daily life and independence. This trial is currently looking for participants of all genders, and it aims to provide valuable information that could help improve treatment options for stroke survivors in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients of legal age, with spasticity in the upper limb due to stroke, with a minimum evolution time of 12 months, who, after being informed orally and in writing of the objectives of the study, sign the informed consent form (themselves or their legal representatives).
• Exclusion Criteria:
• • Absence of consent, refusal of possible surgical treatment, stroke evolution time of less than 12 months, anaesthetic risk (ASA) class IV or higher, presence of involuntary movements, inability to respond adequately to surveys, deformities that cannot be addressed by surgical treatment or inability to follow up for at least one year.