The Effect of Talocrural Joint Manipulation on Static Balance in Patients With Stroke
Phase: NA
Conditions: Stroke
Sponsor: Bitlis Eren University

08.05.2024
THE EFFECT OF TALOCRURAL JOINT MANIPULATION ON STATIC BALANCE 
IN PATIENTS WITH STROKE 
NCT06523010 

STUDYPROTOCOL 
The study with a randomized crossover design was conducted on 32 patients diagnosed with 
stroke. The patients received sham and real talocrural joint manipulation in a randomized order, with 
at least 48 hours between each application. The order of the applications was determined by a coin 
toss. Before and after each application, the patients' postural stability and ankle dorsiflexion range of 
motion were measured. After all measurements were completed, intra- group and inter-group 
comparisons of the data were made. 
Objective: The aim of this study is to evaluate the effect of talocrural joint manipulation on 
postural stability and ankle mobility in stroke patients. 
Design: This study has a randomized crossover design. 
Methods: Stroke patients included in the study were assessed for postural stability 
(anteroposterior, mediolateral, and overall stability) before and after the intervention using the Biodex 
balance system. Ankle mobility was measured using a smartphone level application in two different 
positions: with the knee in extension and in 20 degrees or more of flexion. Balance measurements were 
considered the primary outcome, while ankle mobility was regarded as the secondary outcome. 

08.05.2024
THE EFFECT OF TALOCRURAL JOINT MANIPULATION ON STATIC BALANCE 
IN PATIENTS WITH STROKE 
NCT06523010 

INFORMED CONSENT FORM 
PLEASE READ CAREFULLY! 
You have been invited to participate in this study. Before agreeing to take part, it is important that you 
understand the purpose of the study and make your decision freely based on this information. Please read this 
information, which has been specifically prepared for you, carefully and feel free to ask for clear answers 
WHAT IS THE PURPOSE OF THE STUDY? 
The purpose of this study is to evaluate whether ankle traction has any effect on the balance and ankle movement range of stroke 
patients. 
WHAT ARE THE ELIGIBILITY CRITERIA? 
In order to be included in this study, you must meet the inclusion or exclusion criteria and sign this consent form. 
WHAT KIND OF PROCEDURE WILL BE CARRIED OUT? 
As part of this study, two different ankle traction procedures will be performed on you in a random order. In one of the ankle 
traction procedures, your ankle will be grasped, but no traction will be performed. In the other procedure, your ankle will be 
grasped, and traction will be applied. You can think of the ankle traction procedure as the ankle version of the commonly known 
back traction procedure. The second procedure will be performed at least two days after the first. 
Before the tapping procedures, your data such as age, height, and weight will be collected through questions, weight measurement, 
and a measuring tape. Data related to your stroke condition will be obtained from the hospital’s data system. Then, your level of 
consciousness will be assessed using the Mini Mental State Examination (MMSE), the functionality of your arms and legs will be 
assessed using the Brunnstrom Recovery Staging System, and your balance will be evaluated using the Biodex Balance System. 
During the MMSE, your consciousness level will be assessed by asking you a series of questions. In the Brunnstrom Recovery Staging 
System, your ability to perform certain activities will be evaluated to determine the recovery level of your arms and legs. The 
Biodex Balance System will assess how much movement you have while standing, including shifts to the sides and front-to-back. For 
the test, you will be asked to remove your shoes and step onto the platform of the device, following its instructions. 
Finally, any changes in the upward movement of your ankle during the tapping procedure will be measured using a phone 
application while you are standing. Once the initial measurements are completed, the first ankle traction 
procedure will be carried out, followed by the second set of measurements. The other ankle traction procedure will then be 
performed, with measurements taken before and after. 
WHAT ARE MY RESPONSIBILITIES? 
Your responsibility during the study is to follow the researchers' instructions precisely. If you do not adhere to this condition, the 
researcher has the authority to exclude you from the study. 
WHAT IS THE TOTAL DURATION OF PARTICIPATION IN THIS STUDY? 
The estimated time for your participation in this study is approximately 10 minutes for each measurement. In total, it will be about 
40 minutes. 
WHAT ARE THE EXPECTED POTENTIAL BENEFITS OF PARTICIPATING IN THE STUDY? 
The expected benefits of this study for you include potential improvements in your balance and upward ankle movement with these 
approaches. Additionally, if the study concludes that ankle traction is beneficial and if you wish, we may offer this treatment to you 
independently after the research is completed. 
WHAT ARE THE EXPECTED POTENTIAL RISKS OF PARTICIPATING IN THE STUDY? 

There are no expected adverse effects related to this procedure, provided that you follow the researchers' instructions. UNDER 
WHAT CONDITIONS CAN I BE EXCLUDED FROM THE STUDY? 
You may be excluded from the study without your consent if you do not follow the researchers' instructions precisely. WHAT ARE 
THE OTHER TREATMENTS? 
Physical therapy treatments are commonly preferred approaches for treating balance problems. In addition to physical therapy, new 
approaches such as local vibration and whole-body vibration are also some of the preferred treatment methods for improving 
balance. 
IN CASE OF ANY INJURY, WHO IS RESPONSIBLE AND WHAT WILL BE DONE? 
In the event of any harm related to the study, the treatment will be provided by the responsible researcher, and the associated 
costs will be covered by the researchers. You are covered for any potential damage (including death or injury) that may occur 
during the procedure. 
WHO SHOULD I CONTACT IF I ENCOUNTER ANY ISSUES DURING THE STUDY? 
If you need to take any medication or undergo training outside the study protocol, or if you need additional information about the 
study, or if you experience any issues, side effects, or other discomforts during the study, you can contact Dr. Ömer DURSUN, 
Assistant Professor, at 0542 608 86 87. 
WILL THE EXPENSES RELATED TO THE STUDY BE COVERED? 
Any tests, physical examinations, and other research-related expenses will not be charged to you or to any public or private 
institution or organization under your coverage. 
WILL I RECEIVE ANY PAYMENT FOR PARTICIPATING IN THE STUDY? 
You will not receive any payment for participating in this study. 
WHAT SHOULD I DO IF I DECIDE NOT TO PARTICIPATE OR IF I WANT TO WITHDRAW FROM THE STUDY? 
Participation in this study is entirely voluntary. You can refuse to participate or withdraw from the study at any stage; even if you 
decide to withdraw, your subsequent care will be ensured. The researcher may remove you from the study without your consent but 
with your knowledge if you do not comply with the treatment protocol, disrupt the study schedule, or for other reasons such as 
improving the effectiveness of the treatment. In this case, your subsequent care will still be guaranteed. 
If you withdraw from the study or are removed by the researcher, your medical data will not be used for scientific purposes. 
WILL CONFIDENTIALITY BE MAINTAINED REGARDING THE INFORMATION RELATED TO MY PARTICIPATION? 
All your medical and personal information will be kept confidential, and even if the study is published, your identity will not be 
disclosed. However, study reviewers, auditors, ethical committees, and official authorities may access your medical information 
when necessary. You will also be able to access your own medical information upon request. 
Consent to Participate in the Study: 
I have read and listened to the two-page document that contains the information that should be provided to the volunteer 
before the study begins. I have asked all the questions I had to the researcher, and I fully understand all the explanations given to 
me, both in writing and orally. I was given enough time to decide whether I want to participate in the study. Under these 
conditions, I give permission to the research investigator to review, transfer, and process my medical information, and I accept the 
invitation to participate in this research voluntarily, without any coercion or pressure. By signing this form, I understand that I will 
not lose any rights granted to me by local laws. 
A signed and dated copy of this form has been provided to me. 

volunteer's consent 
SİGNATURE 
Name & Surname 
 
 
Adress 
 
Date 
 
Phone 
 
RESEARCHER 
SİGNATURE 
Name & Surname 
 
 
Adress 
 
Date 
 
Phone