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NCT Number: NCT07240337

Botulinum Toxin Applications in Hemiplegic Patients

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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Key information

Conditions

Hemiplegia Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

İstanbul Physical Medicine and Rehabilitation Research and Training Hospital

Istanbul, Bahcelievler, 34147, Turkey (Türkiye)

Location status: Recruiting

Location contact

Nurdan Paker, Prof

CONTACT

[email protected]

+902124965000

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

no intervention

Primary outcomes

  1. Change in Spasticity Severity:

    Time frame: Baseline

    Evaluated using the Modified Ashworth Scale (MAS) before and after botulinum toxin treatment. A decrease in MAS scores indicates a reduction in muscle tone and improved spasticity control.

Secondary outcomes

  1. Global Spasticity Index (GSI):

    Time frame: Baseline

    Changes in the GSI values before and after treatment will be analyzed to assess overall spasticity reduction.

  2. Functional Independence Measure (FIM):

    Time frame: Baseline

    Functional outcomes will be assessed using FIM scores. An increase in total FIM score indicates improved functional independence.

  3. Brunnstrom Stage:

    Time frame: Baseline

    Motor recovery stages will be evaluated according to the Brunnstrom classification, with higher stages reflecting greater motor improvement.

  4. Injected Muscle Groups and Dosage:

    Time frame: Baseline

    The relationship between injected muscles, total botulinum toxin dosage, and clinical response will be analyzed to identify patterns associated with greater therapeutic benefit.

Sponsors and collaborators

Lead sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 20, 2025
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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