Post Stroke Spastic HemiplegiaNCT07422428
Overlooked Barrier To Discontinuing Bont-A Therapy
An observational study of Post Stroke Spastic Hemiplegia, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Post Stroke Spastic Hemiplegia
- What is being tested?
- provide information by phone
- Type of treatment
- Injection or infusion
- How many people
- 81 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Sep 2024to 5 Apr 2025
- How long will I take part?
- 12 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients were recruited from outpatient and inpatient clinics at a university's Physical Medicine and Rehabilitation department.
Who may be able to join
- included chronic-phase ischemic or hemorrhagic stroke and spasticity in the upper and/or lower limbs.
Who cannot join
- Patients younger than 18 years, those who had passed away, and those who could not be reached by phone were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Süleyman Demirel University Faculty of Medicine Hospital
Isparta
About this study
Official title: 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.
- Conditions
- Post Stroke Spastic Hemiplegia
- Being tested
- provide information by phone
- Keywords
- Botulinum toxin, Spasticity, Stroke, Treatment Discontinuation
- Medical subject headings
- Muscle Spasticity, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
provide information by phoneOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome
Most PSS patients received only one BoNT-A injection over 12 years
Measured: 2012-2024
Primary Outcome
The primary reason cited for discontinuing BoNT-A therapy was a lack of awareness about the necessity of ongoing treatment.
Measured: 2012-2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start23 Sep 2024
- Primary completion10 Feb 2025
- Study completion5 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Stroke Spastic HemiplegiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 81 participants (actual)
- Target duration
- 12 Years
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halenur Yaman, Suleyman Demirel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07422428
- Sponsor's protocol ID
- SDU-FTR-HALENUR-YAMAN-00000001
- Status last verified
- Feb 2026
- First submitted
- 27 Jan 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: name surname mail
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is The Insuffıcıent Patıent Informatıon An Overlooked Barrıer To Dıscontınuıng Bont-A Therapy For Post-Stroke Spastıcıty? A Retrospectıve Cohort Study
- ClinicalTrials.gov ID
- NCT07422428
- Acronym / sponsor ID
- SDU-FTR-HALENUR-YAMAN-00000001
- Conditions
- Post Stroke Spastic Hemiplegia
- Keywords
- Botulinum toxin, Spasticity, Stroke, Treatment Discontinuation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- 23 Sep 2024 (actual)
- Primary completion
- 10 Feb 2025 (actual)
- Study completion
- 5 Apr 2025 (actual)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 12 Years
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were recruited from outpatient and inpatient clinics at a university's Physical Medicine and Rehabilitation department.
Key inclusion criteria (1 listed)
- included chronic-phase ischemic or hemorrhagic stroke and spasticity in the upper and/or lower limbs.
Key exclusion criteria (1 listed)
- Patients younger than 18 years, those who had passed away, and those who could not be reached by phone were excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| provide information by phonePrevious 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. | Other | – |
Primary outcome
Primary Outcome
Time frame: 2012-2024
Most PSS patients received only one BoNT-A injection over 12 years
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: Yes. name surname mail
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Stroke Spastic Hemiplegia, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome (time frame: 2012-2024). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.