NCT05513157

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2022

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 21, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 24, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2023

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

June 13, 2023

Status Verified

June 1, 2023

Enrollment Period

5 months

First QC Date

August 21, 2022

Last Update Submit

June 11, 2023

Conditions

Keywords

StrokeGait AnalysisCartilageKneeThicknessUltrasonography

Outcome Measures

Primary Outcomes (2)

  • 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.

    Baseline

  • 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.

    Baseline

Secondary Outcomes (2)

  • Muscle Strength Assessment

    Baseline

  • Spasticity Assessment

    Baseline

Study Arms (2)

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

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Stroke Patients

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Altindağ, Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 22555317BACKGROUND
  • 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.

    PMID: 27159891BACKGROUND
  • 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.

    PMID: 22147298BACKGROUND
  • 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.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Kadriye Armutlu, Prof.Dr.

    Hacettepe University

    STUDY CHAIR
  • Süleyman Korkusuz, MSc.

    Hacettepe University

    PRINCIPAL INVESTIGATOR
  • Sibel Kibar, Assoc.Prof.

    Atılım University

    STUDY CHAIR
  • Büşra Seçkinoğulları, MSc

    Hacettepe University

    STUDY CHAIR
  • Serdar Arıtan, Assist.Prof.

    Hacettepe University

    STUDY CHAIR
  • Nihat Özgören, MSc

    Hacettepe University

    STUDY CHAIR
  • Ayla Fil Balkan, Assoc.Prof

    Hacettepe University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 21, 2022

First Posted

August 24, 2022

Study Start

August 15, 2022

Primary Completion

January 20, 2023

Study Completion

February 1, 2023

Last Updated

June 13, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations