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Evaluation of Femoral Cartilage Thickness After Treadmill and Tartan Track Walking

Primary Purpose

Knee Osteoarthritis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
walking
Sponsored by
Pamukkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Knee Osteoarthritis focused on measuring knee osteoarthritis, Cartilage, Ultrasonography

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Be over 40 years old
  • Having been diagnosed with knee OA according to the ACR diagnostic criteria
  • Being diagnosed with stage 1-2 knee OA according to the Kellgren-Lawrence staging criteria

Exclusion Criteria:

  • Having a musculoskeletal or systemic disease that will prevent the exercise
  • History or symptoms of lower extremity surgery, ligament injury, balance disorder, lower extremity injury in the last 6 months
  • Presence of psychiatric or neurological disease affecting cooperation, cognitive and neurological functions

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    knee osteoarthritis

    healthy volunteers

    Arm Description

    In patients with knee osteoarthritis, the thickness of the femoral articular cartilage will be measured with portable USG before and immediately after walking.

    Femoral articular cartilage thickness will be measured with portable USG before and immediately after walking in healthy volunteers.

    Outcomes

    Primary Outcome Measures

    Ultrasonographic Evaluation
    Femoral joint cartilage thickness will be measured with portable USG with telemedicine feature.
    Ultrasonographic Evaluation
    Femoral joint cartilage thickness will be measured with portable USG with telemedicine feature.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 30, 2022
    Last Updated
    March 30, 2022
    Sponsor
    Pamukkale University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05316792
    Brief Title
    Evaluation of Femoral Cartilage Thickness After Treadmill and Tartan Track Walking
    Official Title
    Evaluation of Femoral Cartilage Thickness After Treadmill and Tartan Track Walking in Healthy Individuals and Patients With Knee Osteoarthritis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 15, 2022 (Anticipated)
    Primary Completion Date
    March 15, 2023 (Anticipated)
    Study Completion Date
    June 15, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Pamukkale University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The aim of this study is to measure and compare the femoral cartilage deformation after walking on the treadmill and tartan floor in patients with knee osteoarthritis (OA) and healthy volunteers.
    Detailed Description
    The investigators will recruit 30 patients who will be applied to Physical Medicine and Rehabilitation outpatient clinic and diagnosed with knee OA according to American College of Rheumatology (ACR) criteria and 30 healthy volunteers matched for age and gender. The sociodemographic characteristics and detailed history of the patients included in the study will be questioned and recorded. After a detailed physical examination of all patients, weight and height will be measured, and body mass indexes (BMI) will be calculated. Participants' physical activity levels will be determined based on the World Health Organization's Global Physical Activity Questionnaire. This questionnaire has been reported to provide a valid and reliable estimate of physical activity, Turkish validity and reliability have been established. A repeated measures design will be used in which healthy volunteers and patients with knee OA all complete all loading conditions (30min walking on the treadmill and tartan floor). For this, each group (healthy volunteers and knee OA patients) will first walk on the treadmill and then do tartan ground walking 1 week later. Femoral articular cartilage thickness before and immediately after walking will be measured with portable ultrasonography (USG) with a telemedicine feature. Upon arrival at the treatment unit or area of the tartan track, participants will sit on a treatment table with their knees fully extended for 30 minutes to minimize the effects of previous activity on cartilage. All sessions will be completed at the same time of day to reduce daily variations in cartilage thickness. The dominant leg will be defined as the self-reported limb that the participant chooses to use to kick a ball. All post-load USG procedures will be achieved within 5 minutes after the loading condition. 3 images will be taken from each participant. Two separate evaluators will measure to determine the reliability among the measurers. To equalize the loading, the speed at which each participant walks on the treadmill in 30 minutes will be determined by the pedometer as a brisk walking speed (5 km/h). Again, each participant will walk on the tartan floor with a pedometer and walk for 30 minutes at an equal distance at the same pace as on the treadmill. The pedometer will give a warning when it is below or above the desired speed.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Knee Osteoarthritis
    Keywords
    knee osteoarthritis, Cartilage, Ultrasonography

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Case-Control Study
    Masking
    Outcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    knee osteoarthritis
    Arm Type
    Active Comparator
    Arm Description
    In patients with knee osteoarthritis, the thickness of the femoral articular cartilage will be measured with portable USG before and immediately after walking.
    Arm Title
    healthy volunteers
    Arm Type
    Active Comparator
    Arm Description
    Femoral articular cartilage thickness will be measured with portable USG before and immediately after walking in healthy volunteers.
    Intervention Type
    Other
    Intervention Name(s)
    walking
    Intervention Description
    30 min walking on the treadmill and tartan floor
    Primary Outcome Measure Information:
    Title
    Ultrasonographic Evaluation
    Description
    Femoral joint cartilage thickness will be measured with portable USG with telemedicine feature.
    Time Frame
    just before walking
    Title
    Ultrasonographic Evaluation
    Description
    Femoral joint cartilage thickness will be measured with portable USG with telemedicine feature.
    Time Frame
    within 5 minutes after loading condition

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Be over 40 years old Having been diagnosed with knee OA according to the ACR diagnostic criteria Being diagnosed with stage 1-2 knee OA according to the Kellgren-Lawrence staging criteria Exclusion Criteria: Having a musculoskeletal or systemic disease that will prevent the exercise History or symptoms of lower extremity surgery, ligament injury, balance disorder, lower extremity injury in the last 6 months Presence of psychiatric or neurological disease affecting cooperation, cognitive and neurological functions
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ayse Simsek, m.d.
    Phone
    +905319698492
    Email
    draysesimsek2@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hakan Alkan, Prof.
    Organizational Affiliation
    Pamukkale University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Evaluation of Femoral Cartilage Thickness After Treadmill and Tartan Track Walking

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