Evaluation of Femoral Cartilage Thickness After Treadmill and Tartan Track Walking

Sponsor
Pamukkale University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05316792
Collaborator
(none)
60
2
9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: walking
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Case-Control StudyCase-Control Study
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Evaluation of Femoral Cartilage Thickness After Treadmill and Tartan Track Walking in Healthy Individuals and Patients With Knee Osteoarthritis
Anticipated Study Start Date :
Sep 15, 2022
Anticipated Primary Completion Date :
Mar 15, 2023
Anticipated Study Completion Date :
Jun 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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.

Other: walking
30 min walking on the treadmill and tartan floor

Active Comparator: healthy volunteers

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

Other: walking
30 min walking on the treadmill and tartan floor

Outcome Measures

Primary Outcome Measures

  1. Ultrasonographic Evaluation [just before walking]

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

  2. Ultrasonographic Evaluation [within 5 minutes after loading condition]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Pamukkale University

Investigators

  • Study Director: Hakan Alkan, Prof., Pamukkale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hakan Alkan, Clinical Professor, Pamukkale University
ClinicalTrials.gov Identifier:
NCT05316792
Other Study ID Numbers:
  • PamukkaleU-Simsek-002
First Posted:
Apr 7, 2022
Last Update Posted:
Apr 7, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hakan Alkan, Clinical Professor, Pamukkale University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 7, 2022