HemiplegiaNCT07240337
Botulinum Toxin Applications in Hemiplegic Patients
An observational study of Hemiplegia, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This retrospective study will be conducted by reviewing the medical records of hemiplegic patients who received botulinum toxin treatment between 2017 and 2020 at the Physical Medicine and Rehabilitation outpatient clinic of Istanbul Physical Medicine and Rehabilitation Training and Research Hospital. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hemiplegia
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Oct 2025to 10 Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- Adult, Older adult
Study population: The study population consists of hemiplegic patients aged 18-75 years who received botulinum toxin treatment for upper and/or lower extremity spasticity.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
İstanbul Physical Medicine and Rehabilitation Research and Training Hospital
Istanbul, Bahcelievler, 34147
Nurdan Paker, Prof, +902124965000, nurdanpaker@hotmail.com
About this study
Official title: Retrospective Evaluation of Muscle Selection, Dosage, and Clinical Outcomes in Botulinum Toxin Applications in Hemiplegic Patients
This retrospective study will be conducted by reviewing the medical records of hemiplegic patients who received botulinum toxin treatment between 2017 and 2020 at the Physical Medicine and Rehabilitation outpatient clinic of Istanbul Physical Medicine and Rehabilitation Training and Research Hospital. A total of 35 hemiplegic patients who underwent botulinum toxin injection and had at least two follow-up records (with a 6-month interval) will be included. Sociodemographic and clinical data, stroke-related characteristics, botulinum toxin dosage, injected muscle groups, medications, and comorbidities will be recorded. Functional assessments, including the Functional Independence Measure (FIM) and Brunnstrom stage, as well as spasticity evaluations using the Modified Ashworth Scale and the Global Spasticity Index, will be obtained from patient files.
- Conditions
- Hemiplegia
- Being tested
- no intervention
- Medical subject headings
- Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Spasticity Severity:
Evaluated using the Modified Ashworth Scale (MAS) before and after botulinum toxin treatment. A decrease in MAS scores indicates a reduction in muscle tone and improved spasticity control.
Measured: Baseline
Secondary outcomes (4)
Global Spasticity Index (GSI):
Changes in the GSI values before and after treatment will be analyzed to assess overall spasticity reduction.
Measured: Baseline
Functional Independence Measure (FIM):
Functional outcomes will be assessed using FIM scores. An increase in total FIM score indicates improved functional independence.
Measured: Baseline
Brunnstrom Stage:
Motor recovery stages will be evaluated according to the Brunnstrom classification, with higher stages reflecting greater motor improvement.
Measured: Baseline
Injected Muscle Groups and Dosage:
The relationship between injected muscles, total botulinum toxin dosage, and clinical response will be analyzed to identify patterns associated with greater therapeutic benefit.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start10 Oct 2025
- Primary completion10 Nov 2025 (estimated)
- Study completion10 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Retrospective
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07240337
- Sponsor's protocol ID
- istftreah3
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Evaluation of Muscle Selection, Dosage, and Clinical Outcomes in Botulinum Toxin Applications in Hemiplegic Patients
- ClinicalTrials.gov ID
- NCT07240337
- Acronym / sponsor ID
- istftreah3
- Conditions
- Hemiplegia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 10 Oct 2025 (actual)
- Primary completion
- 10 Nov 2025 (estimated)
- Study completion
- 10 Nov 2025 (estimated)
- First posted
- 20 Nov 2025 (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 retrospective study will be conducted by reviewing the medical records of hemiplegic patients who received botulinum toxin treatment between 2017 and 2020 at the Physical Medicine and Rehabilitation outpatient clinic of Istanbul Physical Medicine and Rehabilitation Training and Research Hospital. A total of 35 hemiplegic patients who underwent botulinum toxin injection and had at least two follow-up records (with a 6-month interval) will be included. Sociodemographic and clinical data, stroke-related characteristics, botulinum toxin dosage, injected muscle groups, medications, and comorbidities will be recorded. Functional assessments, including the Functional Independence Measure (FIM) and Brunnstrom stage, as well as spasticity evaluations using the Modified Ashworth Scale and the Global Spasticity Index, will be obtained from patient files.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population consists of hemiplegic patients aged 18-75 years who received botulinum toxin treatment for upper and/or lower extremity spasticity.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| no interventionno intervention | Other | – |
Primary outcome
Change in Spasticity Severity:
Time frame: Baseline
Evaluated using the Modified Ashworth Scale (MAS) before and after botulinum toxin treatment. A decrease in MAS scores indicates a reduction in muscle tone and improved spasticity control.
4 secondary outcomes
Global Spasticity Index (GSI):
Time frame: Baseline
Functional Independence Measure (FIM):
Time frame: Baseline
Brunnstrom Stage:
Time frame: Baseline
Injected Muscle Groups and Dosage:
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
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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.
İstanbul Physical Medicine and Rehabilitation Research and Training Hospital
Istanbul, Turkey (Türkiye)
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 Hemiplegia, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital 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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 20 Nov 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Spasticity Severity: (time frame: Baseline). 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 Nov 2025.