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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05294224
Other study ID # 210077/10
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 17, 2022
Est. completion date September 30, 2023

Study information

Verified date March 2024
Source Mugla Sitki Koçman University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study perform to investigate the relationship between quadriceps femoris (QF) strength, QF thickness, femoral cartilage thickness, knee function, balance, kinesiophobia and gait of the patients with knee osteoarthritis.


Description:

Osteoarthritis (OA) is one of the most common chronic degenerative diseases in the world, which progresses slowly, can cause pain, stiffness and dysfunction, and reduces the quality of life. OA is particularly common in weight-bearing joints such as the knee and the functional status of patients with OA is adversely affected various factors such as immobility due to pain, decrease in muscle strength and joint range of motion, etc. In relation to this, walking difficulty and decrease in walking speed, balance problems and an increase in the risk of falling are a picture that can be encountered in the later stages of the disease. The aim of this study is to investigate the relationship between QF strength, QF thickness, femoral cartilage thickness, knee function, balance, kinesiophobia and gait of the patients with knee OA.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date September 30, 2023
Est. primary completion date August 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Volunteer patients who applied to the Physical therapy and Rehabilitation department with knee pain Exclusion Criteria: - Individuals who have received intra-articular therapy for gonarthrosis in the last 6 months, who have undergone arthroscopic surgery, and who have additional pathologies in their lower extremities - Individuals with physical, mental and/or psychological disorders that may affect participation in the study

Study Design


Locations

Country Name City State
Turkey Mugla Sitki Koçman University Mugla

Sponsors (2)

Lead Sponsor Collaborator
Dilara Özen Oruk Mugla Sitki Koçman University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary QF muscle thickness QF muscle thickness Day 1
Primary QF muscle strength QF muscle strength Day 1
Primary Femoral cartilage thickness Femoral cartilage thickness Day 1
Primary Knee function Knee function assessment with The Knee injury and Osteoarthritis Outcome Score (KOOS). It is a 42-item questionnaire, including 5 subscales: symptoms, pain, ADLs, sports/recreation, and quality of life. The maximum score a patient can achieve is 100, indicating no knee problems. The minimum score is zero, indicating severe knee problems. Day 1
Primary Kellgreen-Lawrence Radiological Stages Kellgreen-Lawrence Radiological Stages:
Grade 1 (doubtful): doubtful joint space narrowing and possible osteophytic lipping. grade 2 (minimal): definite osteophytes and possible joint space narrowing. grade 3 (moderate): moderate multiple osteophytes, definite narrowing of joint space and some sclerosis and possible deformity of bone ends.
Day 1
Primary Kinesiophobia Tampa Kinesiophobia Scale: The total score of the scale range from 17- 68, where 17 means no kinesiophobia, 68 means severe kinesiophobia, and score ± 37 indicates there is kinesiophobia. Day 1
Primary Balance and gait Tinetti Score: It uses a 3-point ordinal scale of 0, 1 and 2. Gait is scored over 12 and balance is scored over 16 totalling 28. The lower the score on the Tinetti test, the higher the risk of falling. Day 1
Primary Low Extremity Functionality and Fall Risk 30 sec sit to stand test Day 1
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