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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Turkey (Türkiye)

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.

  1. 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

  2. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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.

  1. First posted12 Feb 2024
  2. Study start10 May 2022
  3. Primary completion30 Dec 2022
  4. Study completion13 Apr 2023

Resources

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
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

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.

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