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Botulinum Toxin Applications in Hemiplegic Patients

Recruitingn/aAges 18 Years - 75 YearsAllIstanbul Physical Medicine Rehabilitation Trainin…
NCT07240337 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This retrospective study will be conducted by reviewing the medical records of hemiplegic patients who received botulinum toxin treatment between 2017 and 2020 at the Physical Medicine and Rehabilitation outpatient clinic of Istanbul Physical Medicine and Rehabilitation Training and Research Hospital. A total of 35 hemiplegic patients who underwent botulinum toxin injection and had at least two follow-up records (with a 6-month interval) will be included. Sociodemographic and clinical data, stroke-related characteristics, botulinum toxin dosage, injected muscle groups, medications, and comorbidities will be recorded. Functional assessments, including the Functional Independence Measure (FIM) and Brunnstrom stage, as well as spasticity evaluations using the Modified Ashworth Scale and the Global Spasticity Index, will be obtained from patient files.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Aged between 18 and 75 years, clinically diagnosed with hemiplegia * Received botulinum toxin injection for upper and/or lower extremity spasticity * Availability of recorded data for two time points, including the Functional Independence Measure (FIM), Brunnstrom stage, Modified Ashworth Scale (MAS), Global Spasticity Index (GSI) * Documentation of injected muscles and total administered botulinum toxin dosage Exclusion Criteria: * Missing essential data (e.g., absence of FIM, MAS, GSI, or GAS at either visit) * Major interventions during the follow-up period such as surgery or initiation of intrathecal baclofen pump therapy * Severe concomitant neurological disorders (e.g., progressive neurodegenerative diseases) that interfere with assessment
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What it tests

  • no intervention
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Where

1 site
İstanbul Physical Medicine and Rehabilitation Research and Training Hospital
Istanbul, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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