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CompletedNCT05294224Updated Mar 15, 2024

The Relationship Between Disease Severity and Various Lower Extremity Parameters in Individuals With Knee Osteoarthritis

An observational study in Knee Osteoarthritis and Knee Injuries, sponsored by Dilara Özen Oruk. Completed at 1 site in Turkey. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-03-15.

Sponsored by Dilara Özen Oruk · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
40
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Knee Osteoarthritis
  • Knee Injuries

Keywords

  • muscle thikness
  • cartilage thickness
  • balance
  • postural stability
  • kinesiophobia
  • gait
  • degeneration
  • function
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Volunteer patients who applied to the Physical therapy and Rehabilitation department with knee pain

Inclusion criteria

  • Volunteer patients who applied to the Physical therapy and Rehabilitation department with knee pain

Exclusion criteria

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
04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
40 participants (actual)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. QF muscle thickness

    QF muscle thickness

    Time frame: Day 1

  2. QF muscle strength

    QF muscle strength

    Time frame: Day 1

  3. Femoral cartilage thickness

    Femoral cartilage thickness

    Time frame: Day 1

  4. 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.

    Time frame: Day 1

  5. 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.

    Time frame: Day 1

  6. 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.

    Time frame: Day 1

  7. 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.

    Time frame: Day 1

  8. Low Extremity Functionality and Fall Risk

    30 sec sit to stand test

    Time frame: Day 1

06

Study locations

1 site
  • Mugla Sıtkı Koçman University
    Muğla, 48000, Turkey
07

Registry details

Key details

Study ID
NCT05294224
Lead sponsor
Dilara Özen Oruk
Collaborators
Muğla Sıtkı Koçman University
Responsible party
Dilara Özen Oruk (Research Assistant, Muğla Sıtkı Koçman University) — Sponsor-investigator
First posted
Mar 24, 2022
Start date
Apr 17, 2022
Primary completion
Aug 30, 2022
Completion
Sep 30, 2023
Last update
Mar 15, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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