Botulinum Toxin Applications in Hemiplegic Patients

NCT ID: NCT07240337

Last Updated: 2025-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-10

Study Completion Date

2025-11-10

Brief Summary

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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.

Detailed Description

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Conditions

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Hemiplegia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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no intervention

no intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul Physical Medicine Rehabilitation Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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İstanbul Physical Medicine and Rehabilitation Research and Training Hospital

Istanbul, Bahcelievler, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Facility Contacts

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Nurdan Paker, Prof

Role: primary

+902124965000

Other Identifiers

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istftreah3

Identifier Type: -

Identifier Source: org_study_id

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