NCT07422428

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 23, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2026

Completed
24 days until next milestone

First Posted

Study publicly available on registry

February 20, 2026

Completed
Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

5 months

First QC Date

January 27, 2026

Last Update Submit

February 12, 2026

Conditions

Keywords

Botulinum toxin, Spasticity, Stroke, Treatment Discontinuation

Outcome Measures

Primary Outcomes (2)

  • Primary Outcome

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

    2012-2024

  • Primary Outcome

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

    2012-2024

Interventions

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.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Süleyman Demirel University Faculty of Medicine Hospital

Isparta, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Muscle SpasticityStroke

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
12 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant doctor

Study Record Dates

First Submitted

January 27, 2026

First Posted

February 20, 2026

Study Start

September 23, 2024

Primary Completion

February 10, 2025

Study Completion

April 5, 2025

Last Updated

February 20, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

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Locations