StrokeNCT05920837
Relationship Between Upper Extremity' Viscoelastic Properties and Functionality in Subacute Stroke
An observational study of Stroke and Stiffness of Right Hand, Not Elsewhere Classified, run by University of Gaziantep at 1 site in Turkey (Türkiye).
Trial summary
In stroke patients, the shoulder-upper extremity complex is affected and reduces independence and quality in activities of daily living. Investigating the relationship between the functions of the upper extremity muscles and viscoelastic properties is important in understanding the rehabilitation of individuals with… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Stroke, Stiffness of Right Hand, Not Elsewhere Classified, Muscle Tone Abnormalities
- What is being tested?
- MyotonPRO and Box and Block Test
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Jun 2023to 7 Aug 2023
- 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 50 years
- All sexes
- Adult
Study population: Individuals between the ages of 18 and 50 who had an ischemic stroke for the first time will be included in the study. Individuals with impairments that may affect upper extremity performance will be excluded from the study.
Who may be able to join
- Patients who had ischemic SVO 3-9 months ago Individuals who have had a stroke for the first time MAS ≤ 2 of spasticity in paretic upper extremity
Who cannot join
- TIA survivors Presence of cognitive deficits ( Mini-Mental State Examination score ≥ 24) Presence of another neurological, neuromuscular or orthopedic disease Presence of diseases that cause pain, such as fibromyalgia or arthritis Comorbidity with depression or psychiatric illness
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Tuba Maden
Gaziantep, Sahinbey
Tuba Maden, PhD, 05319340249, tuba.kmaden@gmail.com
About this study
Official title: The Relationship Between Upper Extremity Viscoelastic Properties and Functionality in Sub-acute Stroke Patients
In stroke patients, the shoulder-upper extremity complex is affected and reduces independence and quality in activities of daily living. Investigating the relationship between the functions of the upper extremity muscles and viscoelastic properties is important in understanding the rehabilitation of individuals with stroke.
Read the detailed description
Upper extremity functions of individuals will be measured and correlated with viscoelastic properties of upper extremity muscles. The box and block test will be used for the function test. The viscoelastic properties of the muscles will be measured with the myotonPRO device. Deltoideus, Triceps, Biceps, Brachioradialis and Extansor digitorum longus were evaluated with myotonPRO. The tonus, stiffness and elasticity of muscles were recorded. Assessments will applied bilaterally and average recorded.
- Conditions
- Stroke, Stiffness of Right Hand, Not Elsewhere Classified, Muscle Tone Abnormalities, Functional; Bleeding
- Being tested
- MyotonPRO, Box and Block Test
- Medical subject headings
- Stroke, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyotonPRODevice
Also called Viscoelastic properties
Muscles' viscoelastic properties assess with myotonPRO.
Box and Block TestOther
Also called Functionality Test
Upper extremity's functionality assess with Box and Block Test.
| Study group | Role | What they receive |
|---|---|---|
| Stroke | Sample of stroke patients Receives: Device: MyotonPRO; Other: Box and Block Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stiffness
stiffness (N/m) is a biomechanical feature of the muscle that characterizes its resistance to a contraction or an external force.
Measured: through study completion, an average of one month
Elasticity
The elasticity is measured as a logarithmic decrement (log) of the natural oscillations in the tissue. Logarithmic decrement describes the tissue's ability to restore its shape after being deformed
Measured: through study completion, an average of one month
Tone
Oscillation frequency (Hz) refers to the tone of a muscle while resting,
Measured: through study completion, an average of one month
Functionality- Box and Block Test
Te Box and Block Test (BBT) is one of the most used and recommended tools to evaluate unilateral manual dexterity. The BBT comprises a box divided into two compartments by a wooden separation and 150 small wood cubic blocks (1-inch). The BBT consists of displacing a maximum number of small blocks, one-by-one, from the compartment located on the tested side to the other using the same hand (taking care to pass over the separation). Te score is obtained by counting the number of blocks correctly displaced within 60 s.
Measured: through study completion, an average of one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start26 Jun 2023 (estimated)
- Primary completion31 Jul 2023 (estimated)
- Study completion7 Aug 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Collaborators
- Sanko University
- Responsible party
- Principal investigator, Ogr Uyesi Tuba MADEN, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05920837
- Sponsor's protocol ID
- 2023/04
- Status last verified
- Jun 2023
- First submitted
- 17 Jun 2023
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Maden T, Polat H, Guner MA, Turhan B. Alterations in proximal shoulder muscles in stroke-related pain: a myotonometric study. Ir J Med Sci. 2025 Dec;194(6):2401-2407. doi: 10.1007/s11845-025-04098-w. Epub 2025 Sep 30.
PubMed 41026398
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Upper Extremity Viscoelastic Properties and Functionality in Sub-acute Stroke Patients
- ClinicalTrials.gov ID
- NCT05920837
- Acronym / sponsor ID
- 2023/04
- Conditions
- Stroke, Stiffness of Right Hand, Not Elsewhere Classified, Muscle Tone Abnormalities, Functional; Bleeding
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Collaborators
- Sanko University
- Study start
- 26 Jun 2023 (estimated)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 7 Aug 2023 (estimated)
- First posted
- 27 Jun 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.
In stroke patients, the shoulder-upper extremity complex is affected and reduces independence and quality in activities of daily living. Investigating the relationship between the functions of the upper extremity muscles and viscoelastic properties is important in understanding the rehabilitation of individuals with stroke.
Detailed description
Upper extremity functions of individuals will be measured and correlated with viscoelastic properties of upper extremity muscles. The box and block test will be used for the function test. The viscoelastic properties of the muscles will be measured with the myotonPRO device. Deltoideus, Triceps, Biceps, Brachioradialis and Extansor digitorum longus were evaluated with myotonPRO. The tonus, stiffness and elasticity of muscles were recorded. Assessments will applied bilaterally and average recorded.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke | – | Device: MyotonPRO, Other: Box and Block TestSample of stroke patients |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Age groups
- Adult
- Study population
- Individuals between the ages of 18 and 50 who had an ischemic stroke for the first time will be included in the study. Individuals with impairments that may affect upper extremity performance will be excluded from the study.
Key inclusion criteria (1 listed)
- Patients who had ischemic SVO 3-9 months ago Individuals who have had a stroke for the first time MAS ≤ 2 of spasticity in paretic upper extremity
Key exclusion criteria (1 listed)
- TIA survivors Presence of cognitive deficits ( Mini-Mental State Examination score ≥ 24) Presence of another neurological, neuromuscular or orthopedic disease Presence of diseases that cause pain, such as fibromyalgia or arthritis Comorbidity with depression or psychiatric illness
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 |
|---|---|---|
| MyotonPROAlso: Viscoelastic propertiesMuscles' viscoelastic properties assess with myotonPRO. | Device | Stroke |
| Box and Block TestAlso: Functionality TestUpper extremity's functionality assess with Box and Block Test. | Other | Stroke |
Primary outcome
Stiffness
Time frame: through study completion, an average of one month
stiffness (N/m) is a biomechanical feature of the muscle that characterizes its resistance to a contraction or an external force.
Elasticity
Time frame: through study completion, an average of one month
The elasticity is measured as a logarithmic decrement (log) of the natural oscillations in the tissue. Logarithmic decrement describes the tissue's ability to restore its shape after being deformed
Tone
Time frame: through study completion, an average of one month
Oscillation frequency (Hz) refers to the tone of a muscle while resting,
Functionality- Box and Block Test
Time frame: through study completion, an average of one month
Te Box and Block Test (BBT) is one of the most used and recommended tools to evaluate unilateral manual dexterity. The BBT comprises a box divided into two compartments by a wooden separation and 150 small wood cubic blocks (1-inch). The BBT consists of displacing a maximum number of small blocks, one-by-one, from the compartment located on the tested side to the other using the same hand (taking care to pass over the separation). Te score is obtained by counting the number of blocks correctly displaced within 60 s.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Derived from this study: PubMed 41026398Maden T, Polat H, Guner MA, Turhan B. Alterations in proximal shoulder muscles in stroke-related pain: a myotonometric study. Ir J Med Sci. 2025 Dec;194(6):2401-2407. doi: 10.1007/s11845-025-04098-w. Epub 2025 Sep 30.
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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?
An observational study of Stroke and Stiffness of Right Hand, Not Elsewhere Classified, run by University of Gaziantep 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: status not confirmed, as of the sponsor's last update on 27 Jun 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 Tuba Maden, PhD (05319340249, tuba.kmaden@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stiffness (time frame: through study completion, an average of one month). 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?
On the ClinicalTrials.gov record for NCT05920837, 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 27 Jun 2023.