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CompletedNCT07422428Updated Feb 20, 2026

Overlooked Barrier To Discontinuing Bont-A Therapy

An observational study in Post Stroke Spastic Hemiplegia, sponsored by Suleyman Demirel University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-02-20.

Sponsored by Suleyman Demirel University · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
81
Ages
18 Years to 80 Years
Sex
All
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Study summary

This study aims to evaluate patient adherence to botulinum toxin (BoNT-A) treatment and identify the factors contributing to its discontinuation.

This retrospective cohort study analyzed the medical records of patients who received at least one botulinum toxin treatment for post-stroke spasticity (PSS) from 2012 to 2024. Eighty-one enrolled patients responded to structured questions about their reasons for not consistently continuing BoNT-A treatment.

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Conditions studied

  • Post Stroke Spastic Hemiplegia

Keywords

  • Botulinum toxin, Spasticity, Stroke, Treatment Discontinuation
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In context

Muscle Spasticity

703 studies on the registry are indexed under Muscle Spasticity; 148 are open to participants now.

This study's enrollment of 81 is above the median of 60 across 162 observational studies indexed under Muscle Spasticity.

Browse Muscle Spasticity studies →

Lead sponsor

Suleyman Demirel University is the lead sponsor of 123 studies on the registry; 35 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients were recruited from outpatient and inpatient clinics at a university's Physical Medicine and Rehabilitation department.

Inclusion criteria

  • included chronic-phase ischemic or hemorrhagic stroke and spasticity in the upper and/or lower limbs.

Exclusion criteria

Exclusion Criteria:

  • Patients younger than 18 years, those who had passed away, and those who could not be reached by phone were excluded from the study.
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
81 participants (actual)
Target follow-up
12 Years
Patient registry
Yes

Interventions

  • Otherprovide information by phone

    Previous studies did not question why patients thought they did not benefit from the injection. For example, the expectations of patients who said they did not benefit were excessive.

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What researchers measure

Primary outcomes

  1. Primary Outcome

    Most PSS patients received only one BoNT-A injection over 12 years

    Time frame: 2012-2024

  2. Primary Outcome

    The primary reason cited for discontinuing BoNT-A therapy was a lack of awareness about the necessity of ongoing treatment.

    Time frame: 2012-2024

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Study locations

1 site
  • Süleyman Demirel University Faculty of Medicine Hospital
    Isparta, Turkey (Türkiye)
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References and documents

Study documents

  • Study protocol · May 12, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — name surname mail

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07422428
Lead sponsor
Suleyman Demirel University
Responsible party
Halenur Yaman (assistant doctor, Suleyman Demirel University) — Principal investigator
First posted
Feb 20, 2026
Start date
Sep 23, 2024
Primary completion
Feb 10, 2025
Completion
Apr 5, 2025
Last update
Feb 20, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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