Comparing surgery and botulinum toxin for improving quality of life in stroke patients
SURGERY VS BOTULINUM TOXIN ON QUALITY OF LIFE IN STROKE PATIENTS
This study is testing whether surgery or botulinum toxin injections can help stroke patients feel better and improve their quality of life by reducing muscle stiffness in their arms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental Academic / other |
| Locations | 1 site (Granada) |
| Trial ID | NCT06392633 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults with upper limb spasticity due to stroke, who have had the condition for at least 12 months.
Not a fit: Patients who have not consented to surgical treatment or have severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option that significantly improves the quality of life for stroke patients with upper limb spasticity.
How similar studies have performed: While traditional treatments like botulinum toxin are well-established, the surgical approach being tested is less commonly explored, making this a novel investigation.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Granada
- University of Granada — Granada, Spain (Recruiting)
Study contacts
- Study coordinator: Pedro Hernández-Cortés, MD PhD
- Email: phc@ugr.es
- Phone: 958240721
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.