- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05513157
Investigation of Knee Hyperextension and Femoral Cartilage Thickness in Chronic Stroke Patients
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
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Süleyman Korkusuz, MSc
- Phone Number: +905388675480
- Email: suleymankorkusuz@hacettepe.edu.tr
Study Locations
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Ankara
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Altindağ, Ankara, Turkey, 06100
- Hacettepe University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Chronic stroke patients with knee hyperextension
Chronic stroke patients with a maximum knee extension angle of less than 0 degrees in movement analysis
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Chronic stroke patients without knee hyperextension
Chronic stroke patients with a maximum knee extension angle greater than 0 degrees in movement analysis
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Movement Analysis
Time Frame: Baseline
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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.
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Baseline
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Ultrasonography
Time Frame: Baseline
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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.
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle Strength Assessment
Time Frame: Baseline
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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.
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Baseline
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Spasticity Assessment
Time Frame: Baseline
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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.
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Baseline
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Collaborators and Investigators
Sponsor
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
General 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-59394181-604.01.02-37185
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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