NCT05316792

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable knee-osteoarthritis

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 7, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

September 15, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2023

Completed
Last Updated

April 7, 2022

Status Verified

March 1, 2022

Enrollment Period

6 months

First QC Date

March 30, 2022

Last Update Submit

March 30, 2022

Conditions

Keywords

knee osteoarthritisCartilageUltrasonography

Outcome Measures

Primary Outcomes (2)

  • Ultrasonographic Evaluation

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

    just before walking

  • Ultrasonographic Evaluation

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

    within 5 minutes after loading condition

Study Arms (2)

knee osteoarthritis

ACTIVE COMPARATOR

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

healthy volunteers

ACTIVE COMPARATOR

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

Other: walking

Interventions

walkingOTHER

30 min walking on the treadmill and tartan floor

healthy volunteersknee osteoarthritis

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Walking

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Officials

  • Hakan Alkan, Prof.

    Pamukkale University

    STUDY DIRECTOR

Central Study Contacts

Ayse Simsek, m.d.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Case-Control Study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

March 30, 2022

First Posted

April 7, 2022

Study Start

September 15, 2022

Primary Completion

March 15, 2023

Study Completion

June 15, 2023

Last Updated

April 7, 2022

Record last verified: 2022-03