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StrokeNCT05513157

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

An observational study of Stroke, run by Hacettepe University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 40 to 65 years
Conditions the study is for
Stroke
How many people
40 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Aug 2022to 1 Feb 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 65 years
  • All sexes
  • Adult, Older adult

Study population: Stroke Patients

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Hacettepe University

    Altindağ, Ankara, 06100

Other trials in Turkey (Türkiye)

About this study

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.

Read more

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.

Read the 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.

Conditions
Stroke
Keywords
Stroke, Gait Analysis, Cartilage, Knee, Thickness, Ultrasonography
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05513157
Study groupRoleWhat they receive
Chronic stroke patients with knee hyperextensionChronic stroke patients with a maximum knee extension angle of less than 0 degrees in movement analysis
Chronic stroke patients without knee hyperextensionChronic stroke patients with a maximum knee extension angle greater than 0 degrees in movement analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Movement Analysis

    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.

    Measured: Baseline

  2. Ultrasonography

    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.

    Measured: Baseline

Secondary outcomes (2)

  1. Muscle Strength Assessment

    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.

    Measured: Baseline

  2. Spasticity Assessment

    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.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2022
  2. Study start15 Aug 2022
  3. Primary completion20 Jan 2023
  4. Study completion1 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05513157
Sponsor's protocol ID
E-59394181-604.01.02-37185
Status last verified
Jun 2023
First submitted
21 Aug 2022
Last updated
13 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tunc H, Oken O, Kara M, Tiftik T, Dogu B, Unlu Z, Ozcakar L. Ultrasonographic measurement of the femoral cartilage thickness in hemiparetic patients after stroke. Int J Rehabil Res. 2012 Sep;35(3):203-7. doi: 10.1097/MRR.0b013e3283532736.

    PubMed 22555317

  • Yalcin S, Kara M, Ozturk GT, Ozcakar L. Ultrasonographic measurements of the metacarpal and talar cartilage thicknesses in hemiplegic patients after stroke. Top Stroke Rehabil. 2017 Jan;24(1):1-4. doi: 10.1080/10749357.2016.1183357. Epub 2016 May 9.

    PubMed 27159891

  • Cooper A, Alghamdi GA, Alghamdi MA, Altowaijri A, Richardson S. The relationship of lower limb muscle strength and knee joint hyperextension during the stance phase of gait in hemiparetic stroke patients. Physiother Res Int. 2012 Sep;17(3):150-6. doi: 10.1002/pri.528. Epub 2011 Dec 7.

    PubMed 22147298

  • Korkusuz S, Kibar S, Ozgoren N, Aritan S, Seckinogullari B, Balkan AF. Effect of Knee Hyperextension on Femoral Cartilage Thickness in Stroke Patients. Am J Phys Med Rehabil. 2024 May 1;103(5):371-376. doi: 10.1097/PHM.0000000000002323.

    PubMed 37549370

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke, run by Hacettepe University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Movement Analysis (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05513157, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2023.

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