Overlooked Barrier To Discontinuing Bont-A Therapy

February 12, 2026 updated by: Halenur Yaman, Suleyman Demirel University

Is The Insuffıcıent Patıent Informatıon An Overlooked Barrıer To Dıscontınuıng Bont-A Therapy For Post-Stroke Spastıcıty? A Retrospectıve Cohort Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

81

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Isparta, Turkey (Türkiye)
        • Süleyman Demirel University Faculty of Medicine Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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.

Description

Inclusion Criteria:

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

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Outcome
Time Frame: 2012-2024
Most PSS patients received only one BoNT-A injection over 12 years
2012-2024
Primary Outcome
Time Frame: 2012-2024
The primary reason cited for discontinuing BoNT-A therapy was a lack of awareness about the necessity of ongoing treatment.
2012-2024

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suleyman Demirel University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 23, 2024

Primary Completion (Actual)

February 10, 2025

Study Completion (Actual)

April 5, 2025

Study Registration Dates

First Submitted

January 27, 2026

First Submitted That Met QC Criteria

February 12, 2026

First Posted (Actual)

February 20, 2026

Study Record Updates

Last Update Posted (Actual)

February 20, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SDU-FTR-HALENUR-YAMAN-00000001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

name surname mail

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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