Investigation of Knee Hyperextension and Femoral Cartilage Thickness in Chronic Stroke Patients

June 11, 2023 updated by: Suleyman Korkusuz, Hacettepe University

It is aimed to measure knee hyperextension and knee joint cartilage thickness in chronic stroke patients and to examine the relationship between the factors affecting knee hyperextension and knee joint cartilage thickness.

This study, it is aimed to compare the knee joint cartilage thicknesses of the affected and unaffected extremities and to examine the relationship between knee hyperextension and knee joint cartilage thickness.

The second aim is to compare the knee joint cartilage thickness of the paretic and nonparetic extremities and in stroke patients with and without knee hyperextension.

The hypotheses of the study are:

Hypothesis 1;

H0: There is no difference between the knee joint cartilage thickness of the affected and unaffected extremities in chronic stroke patients with knee hyperextension.

H1: In chronic stroke patients with knee hyperextension, there is a difference between the knee joint cartilage thicknesses of the affected and unaffected extremities.

Hypothesis 2;

H0: There is no relationship between knee hyperextension during the stance phase of gait and knee joint cartilage thickness in chronic stroke patients.

H1: There is a relationship between knee hyperextension during the stance phase of gait and knee joint cartilage thickness in chronic stroke patients.

Hypothesis 3;

H0: There is no relationship between lower extremity muscle strength and spasticity and knee joint cartilage thickness in chronic stroke patients with knee hyperextension.

H1: There is a relationship between lower extremity muscle strength and spasticity and knee joint cartilage thickness in chronic stroke patients with knee hyperextension.

Hypothesis 4;

H0: There is no difference between the cartilage thickness of the knee joint in chronic stroke patients with and without knee hyperextension.

H1: There is a difference between the cartilage thickness of the knee joint in chronic stroke patients with and without knee hyperextension.

Study Overview

Status

Completed

Conditions

Detailed Description

Immobilization of extremities after stroke causes articular cartilage degeneration. Likewise, since patients tend to transfer weight to the non-paretic extremity, a load difference occurs between the lower extremity joints. Therefore, it is thought that the femoral cartilage thickness will be affected in stroke patients. Considering this information, it is thought that the femoral cartilage thickness will be different between the paretic and non-paretic extremities, and also between stroke patients with and without knee hyperextension in the stance phase. Accordingly, the first aim of this study is to measure knee hyperextension and femoral cartilage thickness (paretic and nonparetic side) of stroke patients. The second aim is to compare the femoral cartilage thickness of the paretic and nonparetic extremities and in stroke patients with and without knee hyperextension.

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Ankara
      • Altindağ, Ankara, Turkey, 06100
        • Hacettepe University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Stroke Patients

Description

Inclusion Criteria:

  • Being between the ages of 40-65
  • At least 6 months have passed since the stroke

Ambulation with or without a walking aid (walker, cane, or tripod)

  • Being between 0-3 points according to the Modified Rankin Score
  • Getting a score of 24 or higher on the Mini Mental Test
  • Volunteering to participate in the study

Exclusion Criteria:

  • Having a history of more than one stroke
  • Known presence of dementia
  • Having a known orthopedic, psychiatric or other neurological disease
  • Having a situation that prevents communication
  • Having a history of surgery involving lower extremities and gait

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Chronic stroke patients with knee hyperextension
Chronic stroke patients with a maximum knee extension angle of less than 0 degrees in movement analysis
Chronic stroke patients without knee hyperextension
Chronic stroke patients with a maximum knee extension angle greater than 0 degrees in movement analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Movement Analysis
Time Frame: Baseline
Reflective signs will be placed on certain anatomical points on the participants and participants will be asked to walk at a distance of 5 meters. The three-dimensional positions of these reflective marks will be captured by the 8-camera Vicon motion capture system and recorded in the computer environment using Blade software.
Baseline
Ultrasonography
Time Frame: Baseline
Ultrasonographic evaluations were made by the same investigator using a linear/convex probe. In the supine position, with the knees fully flexed, the linear probe was placed axially in the suprapatellar region, and the distal femoral cartilage thickness was measured from the midpoints of the lateral femoral condyle, intercondylar area and medial femoral condyle. Outcome values were determined by taking the average of three consecutive measurements.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle Strength Assessment
Time Frame: Baseline
Manual muscle testing will be performed on patients' lower extremity muscles (hip flexors, hip extensors, hip abductors, hip adductors, knee flexors, knee extensors, dorsiflexors, and plantar flexors). Manual muscle testing, Dr. It will be applied according to the method developed by Robert W. Lowett. According to this method, points between 0 and 5 will be given to the muscles according to the ability of the muscles to move against gravity in certain positions and the resistance of the movement against gravity.
Baseline
Spasticity Assessment
Time Frame: Baseline
Spasticity will be evaluated in patients' quadriceps muscle, hip extensors, hip adductors, hip internal retractors, and plantar flexors. Spasticity assessment will be made according to the Modified Ashword Scale and points will be given between 0 and 4. The method does not require any device and points are given between 0 and 4 according to the resistance of the muscles to be evaluated in the supine position against passive movement.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Study Chair: Büşra Seçkinoğulları, MSc, Hacettepe University
  • Study Chair: Nihat Özgören, MSc, Hacettepe University
  • Study Chair: Kadriye Armutlu, Prof.Dr., Hacettepe University
  • Principal Investigator: Süleyman Korkusuz, MSc., Hacettepe University
  • Study Chair: Sibel Kibar, Assoc.Prof., Atılım University
  • Study Chair: Serdar Arıtan, Assist.Prof., Hacettepe University
  • Study Chair: Ayla Fil Balkan, Assoc.Prof, Hacettepe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2022

Primary Completion (Actual)

January 20, 2023

Study Completion (Actual)

February 1, 2023

Study Registration Dates

First Submitted

August 21, 2022

First Submitted That Met QC Criteria

August 21, 2022

First Posted (Actual)

August 24, 2022

Study Record Updates

Last Update Posted (Actual)

June 13, 2023

Last Update Submitted That Met QC Criteria

June 11, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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