StrokeNCT06006988
Trunk Control and Viscoelastic Properties of Trunk Muscles in Acute Stroke Patients
A study testing myoton pro in people with Stroke, run by Sanko University at 1 site in Turkey (Türkiye).
Trial summary
Stroke is a health problem that ranks second among the causes of death and third in the rate of severe disability . One of the most commonly reported problems after stroke is the structural and functional changes in the muscles . Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- myoton pro
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2023to 1 Dec 2023
- Phase
- Interventional
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with ischemic cerebro-vascular disease within the first 72 hours,
- Patients with a National Institute of Health (NIH) score below 15
- No additional neurological and orthopedic problems
- Patients who do not have any inconvenience in sitting hemodynamically
- agree to participate in the study voluntarily
Who cannot join
- Patients who come to the service outside the first 72 hours
- Uncooperative patients
- patients who have had two or more strokes
- Those who have had a Trans Ischemic Attack (TIA)
- Refused to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sanko University
Gaziantep, 27500
hakan polat, Dr., 05386487265, hakan.polat@sanko.edu.tr
About this study
Official title: Investigation of the Relationship Between Trunk Control and Viscoelastic Properties of Trunk Muscles in Acute Stroke Patients
Stroke is a health problem that ranks second among the causes of death and third in the rate of severe disability . One of the most commonly reported problems after stroke is the structural and functional changes in the muscles . At the beginning of the structural changes of the muscles is the effect of the viscoelastic properties of the muscles. Various studies have reported an increase in skeletal muscle stiffness, which is dependent on elasticity as well as muscle viscosity after stroke . The initial condition of the affected trunk on both the ipsilateral and contralateral sides after stroke is defined as the earliest and most important factor in predicting functional recovery. Functional recovery after stroke was found to be associated with trunk control at a rate of 45-71% in general . We think that viscoelastic properties will change in trunk muscles of individuals with acute stroke and these changes may be related to trunk control disorder.
Read the detailed description
Trunk control is the ability to maintain an upright posture, adjust weight shift, and perform selective movements in the trunk to keep the center of gravity within the base of support . Stroke is one of the main causes of impaired trunk control, including center of gravity and balance reaction . In stroke patients, trunk control ability is decreased in all planes, especially in the frontal plane. Studies have reported that stroke patients have a decrease in trunk muscle strength compared to healthy individuals , and when trunk proprioception is measured in chronic stroke patients, it is affected more than healthy participants . In addition, skeletal muscles undergo various changes after stroke. These changes that occur in the musculoskeletal system are muscle weakness, fatigue, and abnormal muscle tone . Changes at the muscle level include tissue elasticity and viscous properties. In patients with stroke, trunk control should be at a sufficient level in order to ensure functionality in the acute period. Muscle tone and viscoelasticity must be normal in order for trunk control to be at an adequate level. For this reason, in our study, the ability to control the trunk of patients with acute stroke will be associated with the viscoelastic properties of trunk muscles. Gaining a better understanding of changes in tissue distribution by looking at the viscoelasticity of trunk muscles and comparing them to the unaffected intact extremity will lead to better and more targeted interventions for rehabilitation.
The study will be carried out at Sanko University Sani Konukoğlu Practice and Research Hospital. Acute stroke patients who will voluntarily participate in the study will be included.
Inclusion criteria;
- Patients with ischemic cerebro-vascular disease within the first 72 hours,
- Patients with a National Institute of Health (NIH) score below 15
- No additional neurological and orthopedic problems
- Patients who do not have any inconvenience in sitting hemodynamically
- agree to participate in the study voluntarily Exclusion criteria;
- Patients who come to the service outside the first 72 hours
- Uncooperative patients
- patients who have had two or more strokes
- Those who have had a Trans Ischemic Attack (TIA)
- Refused to participate in the study Patients who are hospitalized from SANKO University Hospital Neurology Service will be included in the study. Socio-demographic information of the included patients will be obtained. Then, trunk impairment scale, which is a 17-item scale developed to evaluate trunk performance in stroke patients, will be used for trunk control . MyotonPro device will be used to measure the elasticity of Thoracis Longissimus, Lumbar Multifidus, Trapeze and Rectus Femoris muscles.
Demographic information form: this form is a form that evaluates the demographic information, contact information and general information of individuals.
Trunk impairment scale: It is a 17-parameter scale developed to evaluate trunk control in patients with neurological deficits . Existing sections in the scale; static sitting balance (GBÖ Static), dynamic sitting balance (GBÖ Dynamic) and coordination (GBÖ Coordination). The total score is a minimum of 0 and a maximum of 23 points and it is accepted that the higher score shows better performance. For the initial position in all items, the patients are asked to sit with the thighs parallel to the floor, feet in full contact with the ground, knees flexed to 90º, without back support, with the hands and forearms supported on the thighs. All items are repeated 3 times and the best performance of the patient is recorded. In between tests, the patient is given stimuli and verbal or visual feedback by the observer. A total score of 0 is given to individuals who cannot maintain the starting position for 10 seconds. A Turkish validity and reliability study of the GBS in stroke patients was performed .
MyotonPRO is a mobile, removable handheld myotonometer. This tool is noninvasive and provides a quantitative assessment of a muscle's viscoelastic properties. These properties are characterized by various parameters such as hardness, tone and elasticity. The probe of MyotonPRO delivers a short (15 ms), low intensity (0.58 N) mechanical impact/impact on the skin on the muscle. The response of the touch then generates a recorded signal and an internal software program generates an acceleration graph. Measurements of various viscoelastic muscle properties such as stiffness, tone, and elasticity are then extracted from this graph . Measurements of Thoracis Longissimus, Lumbar Multifidus, Trapeze and Rectus Femoris muscles will be recorded bilaterally, in 3-repetition measurements.
- Conditions
- Stroke
- Being tested
- myoton pro
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myoton proCombination product
MyotonPRO is a mobile, removable handheld myotonometer. This tool is noninvasive and provides a quantitative assessment of a muscle's viscoelastic properties. These properties are characterized by various parameters such as hardness, tone and elasticity. The probe of MyotonPRO delivers a short (15 ms), low intensity (0.58 N) mechanical impact/impact on the skin on the muscle. The response of the touch then generates a recorded signal and an internal software program generates an acceleration graph. Measurements of various viscoelastic muscle properties such as stiffness, tone and elasticity are then extracted from this graph.
| Study group | Role | What they receive |
|---|---|---|
| trunk disorder scale | Experimental | It is a 17-parameter scale developed for the evaluation of trunk control. Existing sections in the scale; static sitting balance (GBÖ Static), dynamic sitting balance (GBÖ Dynamic) and coordination (GBÖ Coordination). The total score is a minimum of 0 and a maximum of 23 points and it is accepted that the higher score shows better performance. Receives: Combination Product: myoton pro |
What is being measured
The primary outcome is the main question the study is designed to answer.
trunk disorder scale
It is a scale consisting of 17 parameters developed for the evaluation of trunk control in patients with neurological deficits (EK8). Existing sections in the scale; static sitting balance (GBÖ Static), dynamic sitting balance (GBÖ Dynamic) and coordination (GBÖ Coordination). The total score is a minimum of 0 and a maximum of 23 points and it is accepted that the higher score shows better performance. For the initial position in all items, the patients are asked to sit with the thighs parallel to the floor, feet in full contact with the ground, knees flexed to 90º, without back support, with the hands and forearms supported on the thighs. All items are repeated 3 times and the best performance of the patient is recorded. In between tests, the patient is given stimuli and verbal or visual feedback by the observer.
Measured: 1 weeks
viscoelastic properties of muscle
MyotonPRO is a mobile, removable handheld myotonometer. This tool is noninvasive and provides a quantitative assessment of a muscle's viscoelastic properties. These properties are characterized by various parameters such as hardness, tone and elasticity. The probe of MyotonPRO delivers a short (15 ms), low intensity (0.58 N) mechanical impact/impact on the skin on the muscle. The response of the touch then generates a recorded signal and an internal software program generates an acceleration graph. Measurements of various viscoelastic muscle properties such as stiffness, tone and elasticity are then extracted from this graph. Measurements of Thoracis Longissimus, Lumbar Multifidus, Trapeze and Rectus Femoris muscles will be recorded bilaterally, in 3-repetition measurements.
Measured: 1 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start1 Aug 2023
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanko University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hakan Polat, Sanko University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06006988
- Sponsor's protocol ID
- DrHakanPolat
- Status last verified
- Aug 2023
- First submitted
- 1 Aug 2023
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Polat H, Maden T, Ekmekyapar Firat Y. Impact of resting muscle tone and stiffness in acute stroke survivors: which muscles' tone correlates with trunk control? a cross-sectional study. Top Stroke Rehabil. 2026 Mar 28:1-10. doi: 10.1080/10749357.2026.2651793. Online ahead of print.
PubMed 41904612
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Trunk Control and Viscoelastic Properties of Trunk Muscles in Acute Stroke Patients
- ClinicalTrials.gov ID
- NCT06006988
- Acronym / sponsor ID
- DrHakanPolat
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sanko UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 23 Aug 2023 (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.
Stroke is a health problem that ranks second among the causes of death and third in the rate of severe disability . One of the most commonly reported problems after stroke is the structural and functional changes in the muscles . At the beginning of the structural changes of the muscles is the effect of the viscoelastic properties of the muscles. Various studies have reported an increase in skeletal muscle stiffness, which is dependent on elasticity as well as muscle viscosity after stroke . The initial condition of the affected trunk on both the ipsilateral and contralateral sides after stroke is defined as the earliest and most important factor in predicting functional recovery. Functional recovery after stroke was found to be associated with trunk control at a rate of 45-71% in general . We think that viscoelastic properties will change in trunk muscles of individuals with acute stroke and these changes may be related to trunk control disorder.
Detailed description
Trunk control is the ability to maintain an upright posture, adjust weight shift, and perform selective movements in the trunk to keep the center of gravity within the base of support . Stroke is one of the main causes of impaired trunk control, including center of gravity and balance reaction . In stroke patients, trunk control ability is decreased in all planes, especially in the frontal plane. Studies have reported that stroke patients have a decrease in trunk muscle strength compared to healthy individuals , and when trunk proprioception is measured in chronic stroke patients, it is affected more than healthy participants . In addition, skeletal muscles undergo various changes after stroke. These changes that occur in the musculoskeletal system are muscle weakness, fatigue, and abnormal muscle tone . Changes at the muscle level include tissue elasticity and viscous properties. In patients with stroke, trunk control should be at a sufficient level in order to ensure functionality in the acute period. Muscle tone and viscoelasticity must be normal in order for trunk control to be at an adequate level. For this reason, in our study, the ability to control the trunk of patients with acute stroke will be associated with the viscoelastic properties of trunk muscles. Gaining a better understanding of changes in tissue distribution by looking at the viscoelasticity of trunk muscles and comparing them to the unaffected intact extremity will lead to better and more targeted interventions for rehabilitation.
The study will be carried out at Sanko University Sani Konukoğlu Practice and Research Hospital. Acute stroke patients who will voluntarily participate in the study will be included.
Inclusion criteria;
- Patients with ischemic cerebro-vascular disease within the first 72 hours,
- Patients with a National Institute of Health (NIH) score below 15
- No additional neurological and orthopedic problems
- Patients who do not have any inconvenience in sitting hemodynamically
- agree to participate in the study voluntarily Exclusion criteria;
- Patients who come to the service outside the first 72 hours
- Uncooperative patients
- patients who have had two or more strokes
- Those who have had a Trans Ischemic Attack (TIA)
- Refused to participate in the study Patients who are hospitalized from SANKO University Hospital Neurology Service will be included in the study. Socio-demographic information of the included patients will be obtained. Then, trunk impairment scale, which is a 17-item scale developed to evaluate trunk performance in stroke patients, will be used for trunk control . MyotonPro device will be used to measure the elasticity of Thoracis Longissimus, Lumbar Multifidus, Trapeze and Rectus Femoris muscles.
Demographic information form: this form is a form that evaluates the demographic information, contact information and general information of individuals.
Trunk impairment scale: It is a 17-parameter scale developed to evaluate trunk control in patients with neurological deficits . Existing sections in the scale; static sitting balance (GBÖ Static), dynamic sitting balance (GBÖ Dynamic) and coordination (GBÖ Coordination). The total score is a minimum of 0 and a maximum of 23 points and it is accepted that the higher score shows better performance. For the initial position in all items, the patients are asked to sit with the thighs parallel to the floor, feet in full contact with the ground, knees flexed to 90º, without back support, with the hands and forearms supported on the thighs. All items are repeated 3 times and the best performance of the patient is recorded. In between tests, the patient is given stimuli and verbal or visual feedback by the observer. A total score of 0 is given to individuals who cannot maintain the starting position for 10 seconds. A Turkish validity and reliability study of the GBS in stroke patients was performed .
MyotonPRO is a mobile, removable handheld myotonometer. This tool is noninvasive and provides a quantitative assessment of a muscle's viscoelastic properties. These properties are characterized by various parameters such as hardness, tone and elasticity. The probe of MyotonPRO delivers a short (15 ms), low intensity (0.58 N) mechanical impact/impact on the skin on the muscle. The response of the touch then generates a recorded signal and an internal software program generates an acceleration graph. Measurements of various viscoelastic muscle properties such as stiffness, tone, and elasticity are then extracted from this graph . Measurements of Thoracis Longissimus, Lumbar Multifidus, Trapeze and Rectus Femoris muscles will be recorded bilaterally, in 3-repetition measurements.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| trunk disorder scale | Experimental | Combination Product: myoton proIt is a 17-parameter scale developed for the evaluation of trunk control. Existing sections in the scale; static sitting balance (GBÖ Static), dynamic sitting balance (GBÖ Dynamic) and coordination (GBÖ Coordination). The total score is a minimum of 0 and a maximum of 23 points and it is accepted that the higher score shows better performance. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with ischemic cerebro-vascular disease within the first 72 hours,
Key exclusion criteria (5 listed)
- Patients who come to the service outside the first 72 hours
- Uncooperative patients
- patients who have had two or more strokes
- Those who have had a Trans Ischemic Attack (TIA)
- Refused to participate in 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 |
|---|---|---|
| myoton proMyotonPRO is a mobile, removable handheld myotonometer. This tool is noninvasive and provides a quantitative assessment of a muscle's viscoelastic properties. These properties are characterized by various parameters such as hardness, tone and elasticity. The probe of MyotonPRO delivers a short (15 ms), low intensity (0.58 N) mechanical impact/impact on the skin on the muscle. The response of the touch then generates a recorded signal and an internal software program generates an acceleration graph. Measurements of various viscoelastic muscle properties such as stiffness, tone and elasticity are then extracted from this graph. | Combination product | trunk disorder scale |
Primary outcome
trunk disorder scale
Time frame: 1 weeks
It is a scale consisting of 17 parameters developed for the evaluation of trunk control in patients with neurological deficits (EK8). Existing sections in the scale; static sitting balance (GBÖ Static), dynamic sitting balance (GBÖ Dynamic) and coordination (GBÖ Coordination). The total score is a minimum of 0 and a maximum of 23 points and it is accepted that the higher score shows better performance. For the initial position in all items, the patients are asked to sit with the thighs parallel to the floor, feet in full contact with the ground, knees flexed to 90º, without back support, with the hands and forearms supported on the thighs. All items are repeated 3 times and the best performance of the patient is recorded. In between tests, the patient is given stimuli and verbal or visual feedback by the observer.
viscoelastic properties of muscle
Time frame: 1 weeks
MyotonPRO is a mobile, removable handheld myotonometer. This tool is noninvasive and provides a quantitative assessment of a muscle's viscoelastic properties. These properties are characterized by various parameters such as hardness, tone and elasticity. The probe of MyotonPRO delivers a short (15 ms), low intensity (0.58 N) mechanical impact/impact on the skin on the muscle. The response of the touch then generates a recorded signal and an internal software program generates an acceleration graph. Measurements of various viscoelastic muscle properties such as stiffness, tone and elasticity are then extracted from this graph. Measurements of Thoracis Longissimus, Lumbar Multifidus, Trapeze and Rectus Femoris muscles will be recorded bilaterally, in 3-repetition measurements.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
- Derived from this study: PubMed 41904612Polat H, Maden T, Ekmekyapar Firat Y. Impact of resting muscle tone and stiffness in acute stroke survivors: which muscles' tone correlates with trunk control? a cross-sectional study. Top Stroke Rehabil. 2026 Mar 28:1-10. doi: 10.1080/10749357.2026.2651793. Online ahead of print.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing myoton pro in people with Stroke, run by Sanko 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 23 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hakan Polat (05386487265, hakan.polat@sanko.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
trunk disorder scale (time frame: 1 weeks). 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?
On the ClinicalTrials.gov record for NCT06006988, which also lists 1 linked publication.
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 23 Aug 2023.