HemiplegiaNCT06254573
The Relationship Of Ultrasonographic Measurements With Sarcopenia in Stroke
An observational study of Hemiplegia, run by Kayseri City Hospital at 2 sites in Turkey (Türkiye).
Trial summary
introduction:The aim of this study was to show the relationship of distal femoral cartilage and quadriceps thicknesses with functional status and presence of sarcopenia in ambulatory stroke patients with voluntary movement. Read more about this study
- Who is it for?
- Ages 34 to 89 years
- Conditions the study is for
- Hemiplegia
- How many people
- 48 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 10 May 2022to 13 Apr 2023
- How long will I take part?
- 1 Day
- 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 34 to 89 years
- All sexes
- Adult, Older adult
Study population: Patients who applied to Kayseri City Hospital Physical Medicine and Rehabilitation outpatient clinic and were diagnosed with clinically and radiologically confirmed stroke caused by cerebrovascular disease were included in the study after their consent was obtained. Inclusion and exclusion criteria were stated below.
Who may be able to join
- Between 18 and 90 years old
- Presence of a history of ischemic or hemorrhagic stroke (based on CT and/or magnetic resonance imaging (MRI) report)
- Brunnstrom hemiplegia recovery staging, stage 3≥
Who cannot join
- History of recurrent cerebrovascular accident
- More than 2 years have passed since the history of cerebrovascular accident
- Inflammatory arthritis or any other rheumatic disease
- History of trauma to the knee (cruciate ligament or meniscus trauma)
- Previous knee surgery
- Pre-stroke neurological gait disorder
- Lower extremity amputation
- Knee joint contracture
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Health Sciences University, Kayseri Medicine Faculty
Kayseri, Kocasinan, 38080
Health Sciences University, Kayseri Medicine Faculty
Talas, Kayseri, 38280
About this study
Official title: The Relationship Of Distal Femoral Cartilage And Quadriceps Muscle Thickness With Functional Status And Sarcopenia İn Patients With Stroke
introduction:The aim of this study was to show the relationship of distal femoral cartilage and quadriceps thicknesses with functional status and presence of sarcopenia in ambulatory stroke patients with voluntary movement.
Materials and Method: Forty-eight patients who were diagnosed with stroke due to cerebrovascular disease, had started voluntary movement, and had a motor recovery of 3 or above according to Brunnstrom's Staging were included in this cross-sectional study.
Read the detailed description
Forty-eight patients who were diagnosed with stroke due to cerebrovascular disease, had started voluntary movement, and had a motor recovery of 3 or above according to Brunnstrom's Staging were included in this cross-sectional study. Bilateral distal femoral cartilage thickness and quadriceps femoris (rectus femoris+vastus intermedius) thickness were measured by ultrasonography. In addition, A Simple Questionnaire to Rapidly Diagnose Sarcopenia (SARC-F questionnaire), hand grip strength, muscle mass measurement with Dual energy X-ray absorptiometry (DXA), short physical performance battery (KFPB) tests were performed and the presence of sarcopenia The European Working Group on Sarcopenia in Older People-2 (EWGSOP- 2) were evaluated according to the criteria. Patients' Functional Independence Scale (FIM), Functional Ambulation Scale (FAS), Barthel Index and modified ashworth scale (MAS) were evaluated.
- Conditions
- Hemiplegia
- Keywords
- Distal femoral cartilage thickness, Quadriceps muscle thickness, Functionality, Sarcopenia, Hemiplegia
- Medical subject headings
- Hemiplegia, Sarcopenia
What is being measured
The primary outcome is the main question the study is designed to answer.
Distal Femoral Cartilage Measurement
Horizontal imaging was performed from the suprapatellar region using the patient in the supine position with the knees at maximum flexion, and the femoral cartilage thickness was measured three times separately from 3 different locations: medial, intercondylar and lateral, and the averages were be recorded.
Measured: once at the beginning
Quadriceps Femoris Muscle Thickness Measurement
Each participant was scanned in a relaxed supine position. The examiner placed the probe on the anterior aspect of the thigh, perpendicular to its long axis at a point midway between the anterior superior iliac spine and the proximal end of the patella according to a previous study.The examiner identified the subcutaneous adipose tissue, rectus femoris, vastus intermedius, and the femur. Excess gel was applied to the skin to minimize distortion.
Measured: once at the baseline
Secondary outcomes (8)
Functional Independence Scale
Functional Independence Scale: Functional Independence Scale is a scale consisting of motor and cognitive subheadings and scoring functions. The Functional Independence Scale is scored under 3 main headings: The total score consists of the sum of the scores of 13 motor items and the scores of 5 cognitive items. A high score indicates high functioning status.
Measured: once at the beginning
Brunnstrom Stages of Stroke Recovery
It is used to evaluate the improvement in motor functions. The lowest stage (flaccid stage and no voluntary movement) is stage 1, and the highest stage (period with isolated joint movements) is stage 6. Its validity and reliability have been previously proven.
Measured: once at the baseline
Modified Ashworth Scale
It is a method used to determine the severity of spasticity. It is based on the principle that the physician subjectively rates the resistance he feels during the examination. It is divided into six grades: 0 = normal muscle tone, 1 = slight increase in muscle tone, minimal muscle resistance at the end of the range of motion, 1 + = minimal resistance at less than half of the joint range of motion, 2 = significant muscle resistance at more than half of the joint range of motion. Increased tone, but affected parts can be moved easily, 3=Passive movement is difficult, there is a significant increase in muscle tone, 4=Affected parts are rigid in flexion and extension, there is a severe increase in tone.
Measured: once at the baseline
Barthel Index for Activities of Daily Living
It is used to measure the level of disability experienced by the patient during daily living activities. Barthel index consists of a total of 10 main items. Nutrition, wheelchair-bed transfer, self-care, sitting and standing on the toilet, washing, walking on smooth surfaces, going up and down stairs, dressing and undressing, bowel and bladder care are questioned. The total score is evaluated between 0 and 100. 0-20 points: fully dependent, 21-61 points: severely dependent, 62-90 points: moderately dependent, 91-99: slightly dependent, 100 points: fully independent.
Measured: once at the baseline
Functional Ambulation Scale
It classifies patients according to the motor skills required for functional ambulation. It was developed in 1984. Six different functional ambulation stages have been determined: Stage 0 for patients who cannot walk or who need physical support or supervision from more than one person to walk other than the parallel bar, and Stage 5 for patients who ambulate independently at any speed on flat and uneven surfaces, slopes and stairs.
Measured: once at the baseline
Evaluation of Muscle Mass
The most common method used to evaluate muscle mass and body composition in stroke patients is Dual-energy X-ray absorptiometry (DXA). Total muscle mass is related to body size. Therefore, appendicular skeletal muscle mass measured on DXA; Appendicular Skeletal Muscle Index (ASM)/height²), that is, appendicular muscle mass (ASMI), was calculated by correcting for height to adapt it to body size, and muscle mass was evaluated. The recommended cut-off point for ASMI was <7.26 kg/m2 for men and <5.5 kg/m2 for women. Patients with low ASMI were evaluated as sarcopenia.
Measured: once at the baseline
Evaluation of Muscle Performance
The short physical performance battery is used in both medical research and clinical practice to evaluate lower extremity physical performance. It evaluates balance, walking speed and endurance. The total score is 12 points, with ≤ 8 points indicating poor physical performance. In our study, if the physical performance of the person diagnosed with sarcopenia was low, it was considered as severe sarcopenia.
Measured: once at the beginning
Evaluation of Muscle Strength
In general, hand grip strength is one of two methods used to measure muscle strength in patients with suspected sarcopenia. Hand grip strength is related to strength in other muscles and can therefore be used as a tool to demonstrate muscle weakness. The hydraulic hand dynamometer was used in all patients included in our study, and measurements were recorded in kilogram. Measurements were made with the patient in a sitting position on a chair, with the elbow close to the body and 90 degrees of flexion, and the wrist in neutral. Patients were asked to grasp the dynamometer as firmly as possible. Three measurements were taken for the patients and the average was taken. The recommended cut-off point for the hand grip test was considered to be <27 kg for men and <16 kg for women. Patients with low hand grip strength were evaluated as having possible sarcopenia.
Measured: once at the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start10 May 2022
- Primary completion30 Dec 2022
- Study completion13 Apr 2023
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
- Cross-sectional
- Enrolment
- 48 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Kayseri City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Havva Talay Çalış, Kayseri City Hospital
- Investigators
- HAVVA TALAY ÇALIŞ, Principal investigator, KAYSERİ CITY HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06254573
- Sponsor's protocol ID
- Kayseri CH06
- Status last verified
- Feb 2024
- First submitted
- 24 Jan 2024
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Of Distal Femoral Cartilage And Quadriceps Muscle Thickness With Functional Status And Sarcopenia İn Patients With Stroke
- ClinicalTrials.gov ID
- NCT06254573
- Acronym / sponsor ID
- Kayseri CH06
- Conditions
- Hemiplegia
- Keywords
- Distal femoral cartilage thickness, Quadriceps muscle thickness, Functionality, Sarcopenia, Hemiplegia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Kayseri City HospitalOther government
- Study start
- 10 May 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 13 Apr 2023 (actual)
- First posted
- 12 Feb 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.
introduction:The aim of this study was to show the relationship of distal femoral cartilage and quadriceps thicknesses with functional status and presence of sarcopenia in ambulatory stroke patients with voluntary movement.
Materials and Method: Forty-eight patients who were diagnosed with stroke due to cerebrovascular disease, had started voluntary movement, and had a motor recovery of 3 or above according to Brunnstrom's Staging were included in this cross-sectional study.
Detailed description
Forty-eight patients who were diagnosed with stroke due to cerebrovascular disease, had started voluntary movement, and had a motor recovery of 3 or above according to Brunnstrom's Staging were included in this cross-sectional study. Bilateral distal femoral cartilage thickness and quadriceps femoris (rectus femoris+vastus intermedius) thickness were measured by ultrasonography. In addition, A Simple Questionnaire to Rapidly Diagnose Sarcopenia (SARC-F questionnaire), hand grip strength, muscle mass measurement with Dual energy X-ray absorptiometry (DXA), short physical performance battery (KFPB) tests were performed and the presence of sarcopenia The European Working Group on Sarcopenia in Older People-2 (EWGSOP- 2) were evaluated according to the criteria. Patients' Functional Independence Scale (FIM), Functional Ambulation Scale (FAS), Barthel Index and modified ashworth scale (MAS) were evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 34 to 89 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who applied to Kayseri City Hospital Physical Medicine and Rehabilitation outpatient clinic and were diagnosed with clinically and radiologically confirmed stroke caused by cerebrovascular disease were included in the study after their consent was obtained. Inclusion and exclusion criteria were stated below.
Key inclusion criteria (3 listed)
- Between 18 and 90 years old
- Presence of a history of ischemic or hemorrhagic stroke (based on CT and/or magnetic resonance imaging (MRI) report)
- Brunnstrom hemiplegia recovery staging, stage 3≥
Key exclusion criteria (8 listed)
- History of recurrent cerebrovascular accident
- More than 2 years have passed since the history of cerebrovascular accident
- Inflammatory arthritis or any other rheumatic disease
- History of trauma to the knee (cruciate ligament or meniscus trauma)
- Previous knee surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Distal Femoral Cartilage Measurement
Time frame: once at the beginning
Horizontal imaging was performed from the suprapatellar region using the patient in the supine position with the knees at maximum flexion, and the femoral cartilage thickness was measured three times separately from 3 different locations: medial, intercondylar and lateral, and the averages were be recorded.
Quadriceps Femoris Muscle Thickness Measurement
Time frame: once at the baseline
Each participant was scanned in a relaxed supine position. The examiner placed the probe on the anterior aspect of the thigh, perpendicular to its long axis at a point midway between the anterior superior iliac spine and the proximal end of the patella according to a previous study.The examiner identified the subcutaneous adipose tissue, rectus femoris, vastus intermedius, and the femur. Excess gel was applied to the skin to minimize distortion.
8 secondary outcomes
Functional Independence Scale
Time frame: once at the beginning
Brunnstrom Stages of Stroke Recovery
Time frame: once at the baseline
Modified Ashworth Scale
Time frame: once at the baseline
Barthel Index for Activities of Daily Living
Time frame: once at the baseline
Functional Ambulation Scale
Time frame: once at the baseline
Evaluation of Muscle Mass
Time frame: once at the baseline
Evaluation of Muscle Performance
Time frame: once at the beginning
Evaluation of Muscle Strength
Time frame: once at the baseline
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 12 Feb 2024.
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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.
HAVVA TALAY ÇALIŞ principal investigator
KAYSERİ CITY HOSPITAL
2 sites 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 Kayseri City Hospital at 2 sites 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 8 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 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Distal Femoral Cartilage Measurement (time frame: once at the beginning). 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?
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 12 Feb 2024.