Botulinum Toxin Applications in Hemiplegic Patients

November 16, 2025 updated by: Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Retrospective Evaluation of Muscle Selection, Dosage, and Clinical Outcomes in 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Bahcelievler
      • Istanbul, Bahcelievler, Turkey (Türkiye), 34147
        • Recruiting
        • İstanbul Physical Medicine and Rehabilitation Research and Training Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

The study population consists of hemiplegic patients aged 18-75 years who received botulinum toxin treatment for upper and/or lower extremity spasticity.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global Spasticity Index (GSI):
Time Frame: Baseline
Changes in the GSI values before and after treatment will be analyzed to assess overall spasticity reduction.
Baseline
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.
Baseline
Brunnstrom Stage:
Time Frame: Baseline
Motor recovery stages will be evaluated according to the Brunnstrom classification, with higher stages reflecting greater motor improvement.
Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2025

Primary Completion (Estimated)

November 10, 2025

Study Completion (Estimated)

November 10, 2025

Study Registration Dates

First Submitted

November 16, 2025

First Submitted That Met QC Criteria

November 16, 2025

First Posted (Actual)

November 20, 2025

Study Record Updates

Last Update Posted (Actual)

November 20, 2025

Last Update Submitted That Met QC Criteria

November 16, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • istftreah3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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