Botulinum Toxin Applications in Hemiplegic Patients
ConditionHemiplegia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorIstanbul Physical Medicine Rehabilitation Training and Research Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
The study population consists of hemiplegic patients aged 18-75 years who received botulinum toxin treatment for upper and/or lower extremity spasticity.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
no intervention
Other interventionno intervention
Treatment groups
No treatment groups listed
Trial outcomes
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.
Time frame
BaselineSecondary outcomes
1
Global Spasticity Index (GSI):
Changes in the GSI values before and after treatment will be analyzed to assess overall spasticity reduction.
Time frame
Baseline2
Functional Independence Measure (FIM):
Functional outcomes will be assessed using FIM scores. An increase in total FIM score indicates improved functional independence.
Time frame
Baseline3
Brunnstrom Stage:
Motor recovery stages will be evaluated according to the Brunnstrom classification, with higher stages reflecting greater motor improvement.
Time frame
Baseline4
Injected Muscle Groups and Dosage:
The relationship between injected muscles, total botulinum toxin dosage, and clinical response will be analyzed to identify patterns associated with greater therapeutic benefit.
Time frame
BaselineSponsors and contacts
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Source ClinicalTrials.gov