NCT05513781

Brief Summary

In this study, it is aimed to examine the factors that cause knee hyperextension in chronic stroke patients. Although the presence of weakness or spasticity in the quadriceps muscle, weakness or spasticity in the plantar flexors, and weakness of the dorsiflexors, hamstrings and gastrocnemius muscle are shown in the literature as the cause of hyperextension of the affected knee in hemiplegic patients, there is a comprehensive study that shows the effect of both muscle strength and spasticity in the lower extremity muscles. there are no studies. The hypotheses of the study are: Hypothesis 1: H0: There is no relationship between knee hyperextension in the stance phase of gait and lower extremity muscle strength in stroke patients. H1: There is a relationship between knee hyperextension in the stance phase of gait and lower extremity muscle strength in stroke patients. Hypothesis 2; H0: There is no relationship between knee hyperextension in the stance phase of gait and lower extremity spasticity in stroke patients. H1: There is a relationship between knee hyperextension in the stance phase of gait and lower extremity spasticity in stroke patients. Hypothesis 3; H0: There is no relationship between knee hyperextension and electromyographic muscle activations in chronic stroke patients. H1: There is a relationship between knee hyperextension and electromyographic muscle activations in chronic stroke patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2022

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 20, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 22, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 24, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2023

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

1.1 years

First QC Date

August 22, 2022

Last Update Submit

February 26, 2024

Conditions

Keywords

Gait AnalysisStrokeKnee HyperextensionElectromyography

Outcome Measures

Primary Outcomes (2)

  • Movement Analysis

    Reflective signs will be placed at certain anatomical points of the participants. Participants will be asked to walk a distance of 5 meters. The three-dimensional positions of these reflective marks will be recorded with the 8-camera Vicon motion capture system. Then it will be examined in computer environment using Blade software.

    Baseline

  • Electromyographic Measurements

    Electromyography (EMG) is frequently used in the literature for motion analysis evaluations. It shows the amplitude of the electrical activity of the muscles. In this study, 8-channel Delsys Bagnoli desktop cable electromyography system (Delsys (Delsys Inc., USA)) will be used. EMG; It shows whether the muscles are active during movement, when they are active and how active they are. In this study, the muscles to be measured by EMG: tibialis anterior, medial gastrocnemius, medial hamstrings, rectus femoris, gluteus medius and the lower part of the latismus dorsi are planned.

    Baseline

Secondary Outcomes (2)

  • Muscle Strength Evaluation

    Baseline

  • Spasticity Evaluation

    Baseline

Study Arms (1)

Chronic stroke patients with knee hyperextension

Eligibility Criteria

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

Chronic Stroke Patients with Knee Hyperextension

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
  • Presence of hyperextension in the stance phase of gait
  • 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

Altındağ, Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (3)

  • Moseley A, Wales A, Herbert R, Schurr K, Moore S. Observation and analysis of hemiplegic gait: stance phase. Aust J Physiother. 1993;39(4):259-67. doi: 10.1016/S0004-9514(14)60486-4.

    PMID: 25026421BACKGROUND
  • Roth EJ, Merbitz C, Mroczek K, Dugan SA, Suh WW. Hemiplegic gait. Relationships between walking speed and other temporal parameters. Am J Phys Med Rehabil. 1997 Mar-Apr;76(2):128-33. doi: 10.1097/00002060-199703000-00008.

    PMID: 9129519BACKGROUND
  • 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

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
  • Serdar Arıtan, Asst.Prof

    Hacettepe University

    STUDY CHAIR
  • Nihat Özgören, MSc

    Hacettepe University

    STUDY CHAIR
  • Ali Naim Ceren, Msc

    Hacettepe University

    STUDY CHAIR
  • Büşra Seçkinoğulları, 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 22, 2022

First Posted

August 24, 2022

Study Start

August 20, 2022

Primary Completion

October 11, 2023

Study Completion

November 15, 2023

Last Updated

February 28, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations