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Recruiting NCT07240337

Botulinum Toxin Applications in Hemiplegic Patients

— Observational Hemiplegia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: no intervention.
Who it may be relevant to
Registry conditions: Hemiplegia. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Other no intervention
    no intervention

Primary outcome measures

  • Change in Spasticity Severity: [Time frame: Baseline]
Secondary outcome measures (4)
  • Global Spasticity Index (GSI): [Time frame: Baseline]
  • Functional Independence Measure (FIM): [Time frame: Baseline]
  • Brunnstrom Stage: [Time frame: Baseline]
  • Injected Muscle Groups and Dosage: [Time frame: Baseline]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • İstanbul Physical Medicine and Rehabilitation Research and Training Hospital — Istanbul

Identifiers

NCT: NCT07240337 · istftreah3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗