NCT05294224

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 24, 2022

Completed
24 days until next milestone

Study Start

First participant enrolled

April 17, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

5 months

First QC Date

March 15, 2022

Last Update Submit

March 12, 2024

Conditions

Keywords

muscle thiknesscartilage thicknessbalancepostural stabilitykinesiophobiagaitdegenerationfunction

Outcome Measures

Primary Outcomes (8)

  • QF muscle thickness

    QF muscle thickness

    Day 1

  • QF muscle strength

    QF muscle strength

    Day 1

  • Femoral cartilage thickness

    Femoral cartilage thickness

    Day 1

  • 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

  • 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

  • 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

  • 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

  • Low Extremity Functionality and Fall Risk

    30 sec sit to stand test

    Day 1

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mugla Sıtkı Koçman University

Muğla, 48000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, KneeKnee InjuriesKinesiophobia

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesLeg InjuriesWounds and InjuriesPhobic DisordersAnxiety DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

March 15, 2022

First Posted

March 24, 2022

Study Start

April 17, 2022

Primary Completion

August 30, 2022

Study Completion

September 30, 2023

Last Updated

March 15, 2024

Record last verified: 2024-03

Locations