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The Effect of Rigid Taping in Chronic Stroke Patients With Knee Hyperextension

Primary Purpose

Chronic Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Rigid Taping
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Stroke focused on measuring Gait Analysis, Stroke, Knee Hyperextension, Rigid Taping

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Hacettepe UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chronic stroke patients with knee hyperextension

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 21, 2022
Last Updated
May 24, 2023
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT05679700
Brief Title
The Effect of Rigid Taping in Chronic Stroke Patients With Knee Hyperextension
Official Title
The Effect of Rigid Taping in Chronic Stroke Patients With Knee Hyperextension
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 20, 2022 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Stroke
Keywords
Gait Analysis, Stroke, Knee Hyperextension, Rigid Taping

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chronic stroke patients with knee hyperextension
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Rigid Taping
Intervention Description
Rigid taping was applied to stroke patients with knee hyperextension.
Primary Outcome Measure Information:
Title
Vicon Motion Capture System
Description
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.
Time Frame
Baseline
Title
Blade Software System
Description
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.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Süleyman Korkusuz, MSc
Phone
05388675480
Email
suleymankorkusuz@hacettepe.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kadriye Armutlu, Prof. Dr.
Organizational Affiliation
Hacettepe University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Süleyman Korkusuz, MSc
Organizational Affiliation
Hacettepe University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mehmet Akif Topçuoğlu, Prof. Dr.
Organizational Affiliation
Hacettepe University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Serdar Arıtan, Asst.Prof
Organizational Affiliation
Hacettepe University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nihat Özgören, MSc
Organizational Affiliation
Hacettepe University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ali Naim Ceren, Msc
Organizational Affiliation
Hacettepe University
Official's Role
Study Chair
Facility Information:
Facility Name
Hacettepe University
City
Altındağ
State/Province
Ankara
ZIP/Postal Code
06230
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Süleyman Korkusuz, MSc
Phone
+905388675480
Email
suleymankorkusuz@hacettepe.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22147298
Citation
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.
Results Reference
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PubMed Identifier
34695721
Citation
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.
Results Reference
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The Effect of Rigid Taping in Chronic Stroke Patients With Knee Hyperextension

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