Botulinum Toxin Applications in Hemiplegic Patients

NCT07240337 | Recruiting

• 1 other identifier: istftreah3
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hemiplegia

Outcome Measures

Primary Outcomes (1)

• Change in Spasticity Severity:

  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 Outcomes (4)

• Global Spasticity Index (GSI):

  Baseline

• Functional Independence Measure (FIM):

  Baseline

• Brunnstrom Stage:

  Baseline

• Injected Muscle Groups and Dosage:

  Baseline

Interventions

no intervention OTHER

no intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Physical Medicine Rehabilitation Training and Research Hospital: lead

Study Sites (1)

İstanbul Physical Medicine and Rehabilitation Research and Training Hospital

Istanbul, Bahcelievler, 34147, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Hemiplegia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 20, 2025
• Study Start: October 10, 2025
• Primary Completion: November 10, 2025
• Study Completion: November 10, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-11

Locations

TU (1)