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Botulinum Toxin Applications in Hemiplegic Patients

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07240337
Enrollment
34
Registered
2025-11-20
Start date
2025-10-10
Completion date
2025-11-10
Last updated
2025-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemiplegia

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.

Interventions

OTHERno intervention

no intervention

Sponsors

Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Spasticity Severity:BaselineEvaluated 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

MeasureTime frameDescription
Global Spasticity Index (GSI):BaselineChanges in the GSI values before and after treatment will be analyzed to assess overall spasticity reduction.
Functional Independence Measure (FIM):BaselineFunctional outcomes will be assessed using FIM scores. An increase in total FIM score indicates improved functional independence.
Brunnstrom Stage:BaselineMotor recovery stages will be evaluated according to the Brunnstrom classification, with higher stages reflecting greater motor improvement.
Injected Muscle Groups and Dosage:BaselineThe relationship between injected muscles, total botulinum toxin dosage, and clinical response will be analyzed to identify patterns associated with greater therapeutic benefit.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026