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Retrospective Evaluation of Muscle Selection, Dosage, and Clinical Outcomes in Botulinum Toxin Applications in Hemiplegic Patients
Led by Istanbul Physical Medicine Rehabilitation Training and Research Hospital · Updated on 2025-11-20
34
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the medical records of hemiplegic patients who received botulinum toxin treatment to better understand muscle selection, dosage, and clinical outcomes. This retrospective study includes 35 patients treated between 2017 and 2020 at the Physical Medicine and Rehabilitation outpatient clinic of Istanbul Physical Medicine and Rehabilitation Training and Research Hospital. The study focuses on patients with hemiplegia who received botulinum toxin injections for spasticity in the upper and/or lower limbs. The study involves reviewing recorded data from two time points spaced six months apart for each patient. Data collected include sociodemographic and clinical information, stroke-related characteristics, botulinum toxin dosage, injected muscle groups, medications, and comorbidities. Functional assessments such as the Functional Independence Measure (FIM) and Brunnstrom stage, along with spasticity evaluations using the Modified Ashworth Scale and Global Spasticity Index, are analyzed to assess treatment effects. Participants' involvement consists of data collection from existing medical records without active intervention. Researchers monitor changes in spasticity severity as the primary outcome, along with secondary measures including the Global Spasticity Index, Functional Independence Measure, Brunnstrom stage, and details on injected muscles and dosage. The study is observational and retrospective, focusing on analyzing clinical outcomes from past treatment records.
CONDITIONS
Brief Title
Botulinum Toxin Applications in Hemiplegic Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 75 years, clinically diagnosed with hemiplegia
- Received botulinum toxin injection for upper and/or lower extremity spasticity
- Have recorded data for two time points including Functional Independence Measure (FIM), Brunnstrom stage, Modified Ashworth Scale (MAS), and Global Spasticity Index (GSI)
- Documentation of injected muscles and total administered botulinum toxin dosage
You will not qualify if you...
- Missing essential data such as FIM, MAS, GSI, or GAS at either visit
- Major interventions during follow-up like surgery or starting intrathecal baclofen pump therapy
- Severe neurological disorders interfering with assessment, such as progressive neurodegenerative diseases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration based on retrospective data from two time points
Participants who have received botulinum toxin injections for hemiplegic spasticity are observed to evaluate muscle selection, dosage, and clinical outcomes using assessments like the Functional Independence Measure, Brunnstrom stage, and spasticity indices.
2 visits (retrospective assessment of baseline and follow-up data)
Trial Site Locations
Total: 1 location
1
İstanbul Physical Medicine and Rehabilitation Research and Training Hospital
Istanbul, Bahcelievler, Turkey (Türkiye), 34147
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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