NCT05679700

Brief Summary

In this study, it is aimed to examine the effect of rigid taping on hyperextension control in stroke patients with knee hyperextension in the stance phase of gait. Hypothesis Ho: Rigid taping has no effect on the control of knee hyperextension in stroke patients. H1: Rigid taping has an effect on the control of knee hyperextension in stroke patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 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

First Submitted

Initial submission to the registry

December 21, 2022

Completed
9 days until next milestone

Study Start

First participant enrolled

December 30, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 11, 2023

Completed
9 months 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

July 8, 2024

Status Verified

July 1, 2024

Enrollment Period

10 months

First QC Date

December 21, 2022

Last Update Submit

July 4, 2024

Conditions

Keywords

Gait AnalysisStrokeKnee HyperextensionRigid Taping

Outcome Measures

Primary Outcomes (2)

  • Vicon Motion Capture System

    A total of 16 reflective signs will be placed on certain anatomical points of the participants. Gait analysis will be performed at a distance of 5 meters from the participants. The three-dimensional positions of the reflective marks will be recorded with the 8-camera Vicon motion capture system.

    Baseline

  • Blade Software System

    Data obtained from Vicon motion capture system will be processed with Blade software. With the blade software, kinematic data will be obtained in the computer environment.

    Baseline

Study Arms (1)

Chronic stroke patients with knee hyperextension

EXPERIMENTAL
Other: Rigid Taping

Interventions

Rigid taping was applied to stroke patients with knee hyperextension.

Chronic stroke patients with knee hyperextension

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having had a stroke at least 6 months ago
  • Ambulation with or without a walking aid (walker, cane or tripod)
  • To be between 0-3 points according to the Modified Rankin Scoring
  • Presence of spasticity in any of the lower extremity muscles with a value of at least 1 according to the Modified Ashworth Scale
  • Getting a score of 24 or higher on the Mini Mental Test
  • Presence of hyperextension in the stance phase of gait

You may not qualify if:

  • Having more than one stroke history
  • Being diagnosed with dementia
  • Having a previous diagnosis of orthopedic, psychiatric or other neurological disease
  • Having a situation that prevents communication
  • History of surgery or joint contracture involving the lower extremities and gait

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Altındağ, Ankara, 06230, Turkey (Türkiye)

Location

Related Publications (3)

  • 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
  • Geerars M, Minnaar-van der Feen N, Huisstede BMA. Treatment of knee hyperextension in post-stroke gait. A systematic review. Gait Posture. 2022 Jan;91:137-148. doi: 10.1016/j.gaitpost.2021.08.016. Epub 2021 Aug 24.

    PMID: 34695721BACKGROUND
  • Korkusuz S, Korkusuz BS, Ozgoren N, Aritan S, Ceren AN, Topcuoglu MA, Balkan AF. Knee hyperextension in chronic stroke: Associated biomechanical and neuromuscular factors. Clin Biomech (Bristol). 2025 Aug;128:106617. doi: 10.1016/j.clinbiomech.2025.106617. Epub 2025 Jul 17.

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
  • Mehmet Akif Topçuoğlu, Prof. Dr.

    Hacettepe 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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 21, 2022

First Posted

January 11, 2023

Study Start

December 30, 2022

Primary Completion

October 11, 2023

Study Completion

November 15, 2023

Last Updated

July 8, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations