- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05679700
The Effect of Rigid Taping in Chronic Stroke Patients With Knee Hyperextension
July 4, 2024 updated by: Suleyman Korkusuz, Hacettepe University
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ankara
-
Altındağ, Ankara, Turkey, 06230
- Hacettepe University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Chronic stroke patients with knee hyperextension
|
Rigid taping was applied to stroke patients with knee hyperextension.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Vicon Motion Capture System
Time Frame: Baseline
|
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
Time Frame: Baseline
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Kadriye Armutlu, 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: Mehmet Akif Topçuoğlu, Prof. Dr., Hacettepe University
- Principal Investigator: Süleyman Korkusuz, MSc, Hacettepe University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 30, 2022
Primary Completion (Actual)
October 11, 2023
Study Completion (Actual)
November 15, 2023
Study Registration Dates
First Submitted
December 21, 2022
First Submitted That Met QC Criteria
January 8, 2023
First Posted (Actual)
January 11, 2023
Study Record Updates
Last Update Posted (Actual)
July 8, 2024
Last Update Submitted That Met QC Criteria
July 4, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KA-22045
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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