RecruitingNCT07240337

Botulinum Toxin Applications in Hemiplegic Patients

Retrospective Evaluation of Muscle Selection, Dosage, and Clinical Outcomes in Botulinum Toxin Applications in Hemiplegic Patients


Sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Enrollment

34 participants

Start Date

Oct 10, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria4

  • 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 Criteria3

  • 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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Interventions

OTHERno intervention

no intervention


Locations(1)

İstanbul Physical Medicine and Rehabilitation Research and Training Hospital

Istanbul, Bahcelievler, Turkey (Türkiye)

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NCT07240337


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