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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06254573
Other study ID # Kayseri CH06
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 10, 2022
Est. completion date April 13, 2023

Study information

Verified date February 2024
Source Kayseri City Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date April 13, 2023
Est. primary completion date December 30, 2022
Accepts healthy volunteers
Gender All
Age group 34 Years to 89 Years
Eligibility Inclusion Criteria: - 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= Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Health Sciences University, Kayseri Medicine Faculty Kayseri Kocasinan
Turkey Health Sciences University, Kayseri Medicine Faculty Talas Kayseri

Sponsors (1)

Lead Sponsor Collaborator
Kayseri City Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. once at the beginning
Primary 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. once at the baseline
Secondary 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. once at the beginning
Secondary 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. once at the baseline
Secondary 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. once at the baseline
Secondary 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. once at the baseline
Secondary 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. once at the baseline
Secondary 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. once at the baseline
Secondary 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. once at the beginning
Secondary 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. once at the baseline
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