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
About this trial
This is an interventional other trial for Knee Osteoarthritis focused on measuring knee osteoarthritis, Cartilage, Ultrasonography
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
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
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
We'll reach out to this number within 24 hrs