HemiplegiaNCT07083752
Investigation of the Effects of Upper Extremity Botulinum Toxin Application on Forearm Muscle Thickness and Motor Recovery in Patients With Hemiplegia
An observational study of Hemiplegia and Spasticity, Muscle, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
In this study, we aimed to examine the effects of the botulinum toxin (BoNT) application on muscle thickness and motor recovery in stroke patients. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Hemiplegia, Spasticity, Muscle
- What is being tested?
- Botulinum toxin application
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Jul 2025to 15 Jul 2025
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study was designed as a retrospective cross-sectional study. The study included patients who had been hospitalized at İzzet Baysal Physical Therapy and Rehabilitation Education and Research Hospital with a diagnosis of hemiplegia due to stroke, had participated in a rehabilitation program, had given informed consent previously, and had received botulinum toxin injections to their upper extremities.
Who may be able to join
- Patients must be between the ages of 30-75.
- Patients who received botulinum toxin injection to their upper extremities at least 3 months after a cerebrovascular accident.
- Patients must have had cerebrovascular disease for the first time.
Who cannot join
- Presence of a preexisting musculoskeletal deformity in the upper extremity where botulinum toxin was administered
- Patients with spinal cord injury, multiple sclerosis, and cerebral palsy
- Presence of malignancy.
Trial locations and contacts
1 site in 1 country.
About this study
In this study, we aimed to examine the effects of the botulinum toxin (BoNT) application on muscle thickness and motor recovery in stroke patients.
Read the detailed description
Stroke is the second leading cause of death worldwide. It poses a major risk for disability. Its prevalence is high in developing countries. Spasticity is among the complications of stroke. Excessive spasticity can cause impairments and limitations in patients' motor activity and participation in daily life. Botulinum toxin (BoNT) injection is one of the preferred treatment options. Studies on botulinum toxin administration in stroke patients generally focus on treatment efficacy and motor recovery. Studies examining the effects of botulinum toxin administration on both muscle thickness and motor recovery are few in number. In this study, we aimed to examine the effects of the botulinum toxin (BoNT) application on upper extremity muscle thickness and motor recovery in stroke patients.
- Conditions
- Hemiplegia, Spasticity, Muscle
- Being tested
- Botulinum toxin application
- Medical subject headings
- Hemiplegia, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin applicationDrug
Hemiplegic stroke patients who received upper extremity botulinum toxin will be evaluated retrospectively. Information regarding upper extremity motor recovery, spasticity levels, and muscle thickness measured by ultrasound before and one month after botulinum toxin administration will be obtained from file records.
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Thickness
Muscle thickness measurements were performed using a Falcon 2101 EXL 2003 ultrasound device equipped with an 8 MHz linear probe, both before and one month after botulinum toxin application.
In patients who received botulinum toxin injections into the m. brachialis, m. pronator teres, m. flexor carpi radialis, m. flexor carpi ulnaris, m. flexor digitorum profundus, and m. flexor digitorum superficialis, muscle thickness was measured using ultrasound from the proximal one-third of the volar side of the forearm. Measurements were taken before and one month after the application. Muscle thickness was recorded by measuring the vertical distance between the subcutaneous tissue and the radius and ulna bone borders on the ultrasound image.
Measured: Before treatment
Muscle Thickness
Muscle thickness measurements were performed using a Falcon 2101 EXL 2003 ultrasound device equipped with an 8 MHz linear probe, both before and one month after botulinum toxin application.
In patients who received botulinum toxin injections into the m. brachialis, m. pronator teres, m. flexor carpi radialis, m. flexor carpi ulnaris, m. flexor digitorum profundus, and m. flexor digitorum superficialis, muscle thickness was measured using ultrasound from the proximal one-third of the volar side of the forearm. Measurements were taken before and one month after the application. Muscle thickness was recorded by measuring the vertical distance between the subcutaneous tissue and the radius and ulna bone borders on the ultrasound image.
Measured: 4 week after treatment
Brunnstrom Motor Recovery Stages
Brunnstrom stages is a scale used to assess motor recovery after a stroke, which is expressed using values between 1 and 6. The higher the value on this scale, the higher would be the recovery.
Measured: Before treatment
Brunnstrom Motor Recovery Stages
Brunnstrom stages is a scale used to assess motor recovery after a stroke, which is expressed using values between 1 and 6. The higher the value on this scale, the higher would be the recovery.
Measured: 4 week after treatment
Secondary outcomes (2)
Modified Ashworth Scale
Spasticity in the shoulder will be evaluated according to the Modified Ashworth Scale (MAS). The Modified Ashworth Scale is a 6-point scale. Scores range from 0 to 4, where lower scores represent normal muscle tone and higher scores represent increased degree of spasticity.
Measured: Before treatment
Modified Ashworth Scale
Spasticity in the shoulder will be evaluated according to the Modified Ashworth Scale (MAS). The Modified Ashworth Scale is a 6-point scale. Scores range from 0 to 4, where lower scores represent normal muscle tone and higher scores represent increased degree of spasticity.
Measured: 4 week after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start13 Jul 2025
- Primary completion15 Jul 2025
- Study completion15 Jul 2025
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.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serdar Kilinc, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07083752
- Sponsor's protocol ID
- AIBU-FTR-SK-10
- Status last verified
- Jul 2025
- First submitted
- 17 Jul 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Upper Extremity Botulinum Toxin Application on Forearm Muscle Thickness and Motor Recovery in Patients With Hemiplegia
- ClinicalTrials.gov ID
- NCT07083752
- Acronym / sponsor ID
- AIBU-FTR-SK-10
- Conditions
- Hemiplegia, Spasticity, Muscle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 13 Jul 2025 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 15 Jul 2025 (actual)
- First posted
- 24 Jul 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.
In this study, we aimed to examine the effects of the botulinum toxin (BoNT) application on muscle thickness and motor recovery in stroke patients.
Detailed description
Stroke is the second leading cause of death worldwide. It poses a major risk for disability. Its prevalence is high in developing countries. Spasticity is among the complications of stroke. Excessive spasticity can cause impairments and limitations in patients' motor activity and participation in daily life. Botulinum toxin (BoNT) injection is one of the preferred treatment options. Studies on botulinum toxin administration in stroke patients generally focus on treatment efficacy and motor recovery. Studies examining the effects of botulinum toxin administration on both muscle thickness and motor recovery are few in number. In this study, we aimed to examine the effects of the botulinum toxin (BoNT) application on upper extremity muscle thickness and motor recovery in stroke patients.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study was designed as a retrospective cross-sectional study. The study included patients who had been hospitalized at İzzet Baysal Physical Therapy and Rehabilitation Education and Research Hospital with a diagnosis of hemiplegia due to stroke, had participated in a rehabilitation program, had given informed consent previously, and had received botulinum toxin injections to their upper extremities.
Key inclusion criteria (3 listed)
- Patients must be between the ages of 30-75.
- Patients who received botulinum toxin injection to their upper extremities at least 3 months after a cerebrovascular accident.
- Patients must have had cerebrovascular disease for the first time.
Key exclusion criteria (3 listed)
- Presence of a preexisting musculoskeletal deformity in the upper extremity where botulinum toxin was administered
- Patients with spinal cord injury, multiple sclerosis, and cerebral palsy
- Presence of malignancy.
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 |
|---|---|---|
| Botulinum toxin applicationHemiplegic stroke patients who received upper extremity botulinum toxin will be evaluated retrospectively. Information regarding upper extremity motor recovery, spasticity levels, and muscle thickness measured by ultrasound before and one month after botulinum toxin administration will be obtained from file records. | Drug | – |
Primary outcome
Muscle Thickness
Time frame: Before treatment
Muscle thickness measurements were performed using a Falcon 2101 EXL 2003 ultrasound device equipped with an 8 MHz linear probe, both before and one month after botulinum toxin application. In patients who received botulinum toxin injections into the m. brachialis, m. pronator teres, m. flexor carpi radialis, m. flexor carpi ulnaris, m. flexor digitorum profundus, and m. flexor digitorum superficialis, muscle thickness was measured using ultrasound from the proximal one-third of the volar side of the forearm. Measurements were taken before and one month after the application. Muscle thickness was recorded by measuring the vertical distance between the subcutaneous tissue and the radius and ulna bone borders on the ultrasound image.
Muscle Thickness
Time frame: 4 week after treatment
Muscle thickness measurements were performed using a Falcon 2101 EXL 2003 ultrasound device equipped with an 8 MHz linear probe, both before and one month after botulinum toxin application. In patients who received botulinum toxin injections into the m. brachialis, m. pronator teres, m. flexor carpi radialis, m. flexor carpi ulnaris, m. flexor digitorum profundus, and m. flexor digitorum superficialis, muscle thickness was measured using ultrasound from the proximal one-third of the volar side of the forearm. Measurements were taken before and one month after the application. Muscle thickness was recorded by measuring the vertical distance between the subcutaneous tissue and the radius and ulna bone borders on the ultrasound image.
Brunnstrom Motor Recovery Stages
Time frame: Before treatment
Brunnstrom stages is a scale used to assess motor recovery after a stroke, which is expressed using values between 1 and 6. The higher the value on this scale, the higher would be the recovery.
Brunnstrom Motor Recovery Stages
Time frame: 4 week after treatment
Brunnstrom stages is a scale used to assess motor recovery after a stroke, which is expressed using values between 1 and 6. The higher the value on this scale, the higher would be the recovery.
2 secondary outcomes
Modified Ashworth Scale
Time frame: Before treatment
Modified Ashworth Scale
Time frame: 4 week after 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 24 Jul 2025.
- Individual participant dataSharing planned: No
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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 Hemiplegia and Spasticity, Muscle, run by Abant Izzet Baysal 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 3 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: finished, as of the sponsor's last update on 24 Jul 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?
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?
Muscle Thickness (time frame: Before treatment). The study lists 4 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 24 Jul 2025.