Evaluation of Femoral Cartilage Thickness After Treadmill and Tartan Track Walking

NCT ID: NCT05316792

Last Updated: 2022-04-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-15
• Study Completion Date: 2023-06-15

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

knee osteoarthritis

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

Group Type: ACTIVE_COMPARATOR

walking

Intervention Type: OTHER

30 min walking on the treadmill and tartan floor

healthy volunteers

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

Group Type: ACTIVE_COMPARATOR

walking

Intervention Type: OTHER

30 min walking on the treadmill and tartan floor

Interventions

walking

30 min walking on the treadmill and tartan floor

Intervention Type: OTHER

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pamukkale University

OTHER

Sponsor Role: lead

Responsible Party

Hakan Alkan

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hakan Alkan, Prof.

Role: STUDY_DIRECTOR

Pamukkale University

Central Contacts

Ayse Simsek, m.d.

Role: CONTACT

draysesimsek2@gmail.com

+905319698492

Other Identifiers

PamukkaleU-Simsek-002

Identifier Type: -

Identifier Source: org_study_id