HemiplegiaNCT06706063
Ultrasonograpy in Hemiplegic Patients
An observational study of Hemiplegia and Hemiparesis After Stroke, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to evaluate the architectural changes and muscle stiffness of the upper and lower extremity muscles in our hemiplegic patients ultrasonographically and to investigate their relationship with clinical assessment scales. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Hemiplegia, Hemiparesis After Stroke, Spasticity
- What is being tested?
- Ultrasonography of muscles
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2022to 15 Jun 2025
- How long will I take part?
- 2 Days
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 100 hemiplegic patients aged between 40-70 years, with unilateral hemiplegia, and at least 3 months after a cerebrovascular accident, who applied to the AFSU Department of Physical Medicine and Rehabilitation will be included.
Who may be able to join
- Age 40-70
- Unilateral hemiplegia
- At least 3 months since cerebrovascular accident
Who cannot join
- Operation or fracture in the last 3 months
- Botulinum toxin injection in the last 6 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Afyonkarahisar Health Sciences University Health Application and Research Center Physical Medicine and Rehabilitation Clinic
Afyonkarahisar
About this study
Official title: Clinical and Ultrasonographic Evaluation of Spasticity in Hemiplegic Patients
The aim of this study was to evaluate the architectural changes and muscle stiffness of the upper and lower extremity muscles in our hemiplegic patients ultrasonographically and to investigate their relationship with clinical assessment scales.
Read the detailed description
Spasticity has been defined as "disorganized sensorimotor control resulting from upper motor neuron lesion, manifested as intermittent or continuous involuntary activation of muscles". Its high prevalence and limited effectiveness of current treatment options make spasticity an important health problem in neurological rehabilitation.
The commonly used tools for the assessment of spasticity are subjective clinical scales, including the Ashworth Scale (AS), Modified AS (MAS), Tardieu Scale (TS), Modified TS (MTS), and Tone Assessment Scale (TAS). Most of these scales have limitations regarding reliability and inter-examiner reproducibility. Many uncontrollable or unstable factors can affect the measurement results.
On the other hand, spasticity can be assessed objectively using isokinetic dynamometers or electromyography (EMG). However, EMG data can be affected by various factors (electrode placement, muscle atrophy, skin resistance, etc.). These quantitative and objective methods require technological skills and equipment and can only assess a limited number of muscles. Ultrasonography has been used to determine muscle size (muscle length and volume), architectural features (thickness, cross-sectional area, fascicle length, and pennation angle), as well as content features (e.g., stiffness) of spastic muscles in patients with central nervous system injuries. In clinical practice, muscle atrophy-loss of contractile tissue-is usually measured by cross-sectional area or thickness (reflecting cross-sectional area) in spastic patients. Ultrasound is also useful for measuring fascicle length and pennation angle, architectural features that determine the muscle movement and force generated along the line of tension, respectively. The fascicle length of the affected muscle on the hemiparetic side of stroke patients was found to be shorter than in nonparetic and healthy controls. In addition to architectural changes, excessive stiffness felt during movement of the segments around the joint causes movement impairment in patients with spasticity. Ultrasound elastography has recently enabled physicians to accurately measure passive muscle stiffness. It has been found that spastic muscle stiffness increases in patients with central nervous system injuries.
Muscles frequently evaluated by ultrasound elastography are biceps and gastrocnemius muscles, which are reported to be highly affected by spasticity. However, the lack of a standard measurement protocol and the variability of elasticity in patients need to be addressed. Since there are few studies investigating the application of ultrasound elastography techniques for measuring muscle stiffness, future studies are needed to understand the mechanical properties of the muscles and to obtain a standard and reliable protocol. In the literature, only one study has evaluated forearm muscles elastographically and found that the elasticity ratio was lower on the hemiplegic side compared to the non-hemiplegic side.
The aim of this study was to evaluate the architectural changes and muscle stiffness of the upper and lower extremity muscles in our hemiplegic patients ultrasonographically and to investigate their relationship with clinical assessment scales.
- Conditions
- Hemiplegia, Hemiparesis After Stroke, Spasticity
- Being tested
- Ultrasonography of muscles
- 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.
Ultrasonography of musclesOther
The biceps brachii, flexor digitorum superficialis and profundus muscles and gastrocnemius muscles of the participants on the affected and unaffected sides will be evaluated ultrasonographically. Two researchers (with at least 5 years of experience in ultrasound imaging) blinded to the clinical evaluations of the patients and previous measurements will evaluate the same patients at two different times to test interobserver reproducibility. Muscle thickness, fascicle length and pennation angle will be recorded on B-mode imaging. In addition, elastographic evaluation will be performed on the same muscles and strain rate will be recorded.
What is being measured
The primary outcome is the main question the study is designed to answer.
Spasticity Evaluation
Spasticity was planned to be evaluated with the Modified Ashworth Scale (MAS). In the MAS, patients are evaluated out of 5 points. 0 indicates no increase in muscle tone, and 4 indicates that the extremity is rigid in the flexion and extension directions.
Measured: T0 (First day), T1 (Second day)
Fugl Meyer Assessment Questionnaire
Fugl-Meyer Motor Assessment Scale was developed to quantitatively assess sensorimotor recovery after stroke. It was prepared based on Brunnstrom's motor recovery stages. Validity and reliability study was conducted in Turkish. The total score is between 0-66 and higher scores indicates better motor functions.
Measured: T0 (First day), T1 (Second day)
Neurophysiological Evaluation
Brunnstrom Staging is a test that evaluates the motor development of hemiplegic patients. In this test, the neurophysiological recovery process of the hemiplegic patient is defined as 6 stages. According to this staging, the lowest stage is stage 1 (flaccid, no voluntary movement stage), and the highest stage is stage 6 (isolated joint movement stage). In Brunnstrom staging, the hand, upper extremity and lower extremity are evaluated separately.
Measured: T0 (First day), T1 (Second day)
Ultrasonographic Evaluation
The biceps brachii, flexor digitorum superficialis and profundus muscles and gastrocnemius muscles of the participants on the affected and unaffected sides will be evaluated ultrasonographically. Two researchers (with at least 5 years of experience in ultrasound imaging) blinded to the clinical evaluations of the patients and previous measurements will evaluate the same patients at two different times to test interobserver reproducibility. Muscle thickness, fascicle length and pennation angle will be recorded in B-mode imaging. In addition, elastographic evaluation will be performed on the same muscles.
Measured: T0 (First day), T1 (Second day)
Secondary outcomes (1)
Functional Independence Measurement (FIM)
It is a scale that evaluates the performance of individuals regarding daily living activities. It consists of 18 items and evaluates the functions of individuals in 2 main sections: physical/motor function (13 items) and cognitive function (5 items). The items are also grouped under 6 subheadings (self-care, sphincter control, transfers, movement, communication and social perception). Each item is scored between 1-7; 1 indicates full assistance and 7 indicates full independence. The total score varies between 18-126 (full dependency-full independence). Adaptation, validity and reliability studies of the scale to the Turkish population have been conducted.
Measured: T0 (First day), T1 (Second day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start15 Apr 2022
- Primary completion15 May 2025 (estimated)
- Study completion15 Jun 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevda Adar, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06706063
- Sponsor's protocol ID
- SAUSG
- Status last verified
- Nov 2024
- First submitted
- 22 Nov 2024
- Last updated
- 2 Dec 2024
- 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 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Ultrasonographic Evaluation of Spasticity in Hemiplegic Patients
- ClinicalTrials.gov ID
- NCT06706063
- Acronym / sponsor ID
- SAUSG
- Conditions
- Hemiplegia, Hemiparesis After Stroke, Spasticity
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 15 May 2025 (estimated)
- Study completion
- 15 Jun 2025 (estimated)
- First posted
- 26 Nov 2024 (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.
The aim of this study was to evaluate the architectural changes and muscle stiffness of the upper and lower extremity muscles in our hemiplegic patients ultrasonographically and to investigate their relationship with clinical assessment scales.
Detailed description
Spasticity has been defined as "disorganized sensorimotor control resulting from upper motor neuron lesion, manifested as intermittent or continuous involuntary activation of muscles". Its high prevalence and limited effectiveness of current treatment options make spasticity an important health problem in neurological rehabilitation.
The commonly used tools for the assessment of spasticity are subjective clinical scales, including the Ashworth Scale (AS), Modified AS (MAS), Tardieu Scale (TS), Modified TS (MTS), and Tone Assessment Scale (TAS). Most of these scales have limitations regarding reliability and inter-examiner reproducibility. Many uncontrollable or unstable factors can affect the measurement results.
On the other hand, spasticity can be assessed objectively using isokinetic dynamometers or electromyography (EMG). However, EMG data can be affected by various factors (electrode placement, muscle atrophy, skin resistance, etc.). These quantitative and objective methods require technological skills and equipment and can only assess a limited number of muscles. Ultrasonography has been used to determine muscle size (muscle length and volume), architectural features (thickness, cross-sectional area, fascicle length, and pennation angle), as well as content features (e.g., stiffness) of spastic muscles in patients with central nervous system injuries. In clinical practice, muscle atrophy-loss of contractile tissue-is usually measured by cross-sectional area or thickness (reflecting cross-sectional area) in spastic patients. Ultrasound is also useful for measuring fascicle length and pennation angle, architectural features that determine the muscle movement and force generated along the line of tension, respectively. The fascicle length of the affected muscle on the hemiparetic side of stroke patients was found to be shorter than in nonparetic and healthy controls. In addition to architectural changes, excessive stiffness felt during movement of the segments around the joint causes movement impairment in patients with spasticity. Ultrasound elastography has recently enabled physicians to accurately measure passive muscle stiffness. It has been found that spastic muscle stiffness increases in patients with central nervous system injuries.
Muscles frequently evaluated by ultrasound elastography are biceps and gastrocnemius muscles, which are reported to be highly affected by spasticity. However, the lack of a standard measurement protocol and the variability of elasticity in patients need to be addressed. Since there are few studies investigating the application of ultrasound elastography techniques for measuring muscle stiffness, future studies are needed to understand the mechanical properties of the muscles and to obtain a standard and reliable protocol. In the literature, only one study has evaluated forearm muscles elastographically and found that the elasticity ratio was lower on the hemiplegic side compared to the non-hemiplegic side.
The aim of this study was to evaluate the architectural changes and muscle stiffness of the upper and lower extremity muscles in our hemiplegic patients ultrasonographically and to investigate their relationship with clinical assessment scales.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Days
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 100 hemiplegic patients aged between 40-70 years, with unilateral hemiplegia, and at least 3 months after a cerebrovascular accident, who applied to the AFSU Department of Physical Medicine and Rehabilitation will be included.
Key inclusion criteria (3 listed)
- Age 40-70
- Unilateral hemiplegia
- At least 3 months since cerebrovascular accident
Key exclusion criteria (2 listed)
- Operation or fracture in the last 3 months
- Botulinum toxin injection in the last 6 months
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 |
|---|---|---|
| Ultrasonography of musclesThe biceps brachii, flexor digitorum superficialis and profundus muscles and gastrocnemius muscles of the participants on the affected and unaffected sides will be evaluated ultrasonographically. Two researchers (with at least 5 years of experience in ultrasound imaging) blinded to the clinical evaluations of the patients and previous measurements will evaluate the same patients at two different times to test interobserver reproducibility. Muscle thickness, fascicle length and pennation angle will be recorded on B-mode imaging. In addition, elastographic evaluation will be performed on the same muscles and strain rate will be recorded. | Other | – |
Primary outcome
Spasticity Evaluation
Time frame: T0 (First day), T1 (Second day)
Spasticity was planned to be evaluated with the Modified Ashworth Scale (MAS). In the MAS, patients are evaluated out of 5 points. 0 indicates no increase in muscle tone, and 4 indicates that the extremity is rigid in the flexion and extension directions.
Fugl Meyer Assessment Questionnaire
Time frame: T0 (First day), T1 (Second day)
Fugl-Meyer Motor Assessment Scale was developed to quantitatively assess sensorimotor recovery after stroke. It was prepared based on Brunnstrom's motor recovery stages. Validity and reliability study was conducted in Turkish. The total score is between 0-66 and higher scores indicates better motor functions.
Neurophysiological Evaluation
Time frame: T0 (First day), T1 (Second day)
Brunnstrom Staging is a test that evaluates the motor development of hemiplegic patients. In this test, the neurophysiological recovery process of the hemiplegic patient is defined as 6 stages. According to this staging, the lowest stage is stage 1 (flaccid, no voluntary movement stage), and the highest stage is stage 6 (isolated joint movement stage). In Brunnstrom staging, the hand, upper extremity and lower extremity are evaluated separately.
Ultrasonographic Evaluation
Time frame: T0 (First day), T1 (Second day)
The biceps brachii, flexor digitorum superficialis and profundus muscles and gastrocnemius muscles of the participants on the affected and unaffected sides will be evaluated ultrasonographically. Two researchers (with at least 5 years of experience in ultrasound imaging) blinded to the clinical evaluations of the patients and previous measurements will evaluate the same patients at two different times to test interobserver reproducibility. Muscle thickness, fascicle length and pennation angle will be recorded in B-mode imaging. In addition, elastographic evaluation will be performed on the same muscles.
1 secondary outcome
Functional Independence Measurement (FIM)
Time frame: T0 (First day), T1 (Second day)
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 2 Dec 2024.
- 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 Hemiparesis After Stroke, run by Afyonkarahisar Health Sciences 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 2 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: under way, not looking for participants, as of the sponsor's last update on 2 Dec 2024. 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?
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?
Spasticity Evaluation (time frame: T0 (First day), T1 (Second day)). 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 2 Dec 2024.