Botulinum toxin use in people with hemiplegia
Official title: Retrospective Evaluation of Muscle Selection, Dosage, and Clinical Outcomes in Botulinum Toxin Applications in Hemiplegic Patients
Run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital · NCT07240337 · Data updated 2026-11-12
This project looks back at medical records to see if botulinum toxin injections helped adults with hemiplegia reduce spasticity and improve function.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 34 (estimated) |
| Sponsor | Istanbul Physical Medicine Rehabilitation Training and Research Hospital Government |
| Locations | 1 site (Istanbul, Bahcelievler) |
| Status | Recruiting |
| Started | October 10, 2025 |
| Main results expected | November 10, 2025 |
| Study ends | November 10, 2025 |
| Registry record updated | November 20, 2025 |
| Trial ID | NCT07240337 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–75 with hemiplegia who received botulinum toxin injections at the listed hospital and have recorded FIM, Brunnstrom, MAS, and GSI data from two visits (about six months apart) are ideal candidates for inclusion.
✕Probably not a fit
Patients with progressive neurodegenerative disorders, those who underwent major interventions like surgery or intrathecal baclofen during follow-up, or those without complete records are unlikely to benefit from this analysis.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-center, retrospective chart review of 35 hemiplegic patients treated with botulinum toxin between 2017 and 2020 at the Istanbul Physical Medicine and Rehabilitation Training and Research Hospital. Patients with at least two recorded visits separated by about six months and complete functional and spasticity measures will be included. Investigators will extract sociodemographic and stroke-related data, injected muscle groups and total toxin dose, medications, and comorbidities. Functional outcomes (FIM, Brunnstrom stage) and spasticity measures (Modified Ashworth Scale, Global Spasticity Index) from two time points will be compared descriptively.
Why it matters
Potential benefit: If findings show meaningful changes, they could inform local clinicians on dosing and muscle targets to better reduce spasticity and support daily function in hemiplegic patients.
How similar studies have gone: Previous studies consistently show botulinum toxin reduces focal spasticity, but evidence for consistent, large improvements in overall functional independence has been mixed.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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İstanbul Physical Medicine and Rehabilitation Research and Training Hospital
Istanbul, Bahcelievler, Turkey (Türkiye) Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.