Comparing surgery and botulinum toxin for improving quality of life in stroke patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of surgical treatment versus botulinum toxin injections for managing upper limb spasticity in stroke patients. It involves a randomized controlled design with two groups: one receiving surgery and the other receiving botulinum toxin. The study will assess various outcomes, including functionality, quality of life, sleep quality, anxiety, depression, and brain activity through Functional Magnetic Resonance Imaging at baseline and follow-up intervals of 6 and 12 months. Additionally, the economic impact of both treatment approaches will be analyzed.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Granada
  Granada, Spain Recruiting

Study contacts

• Study coordinator: Pedro Hernández-Cortés, MD PhD
• Email: phc@ugr.es
• Phone: 958240721

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Dual-task balance training plus computer-based cognitive training after stroke

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.