Variability in Spatiotemporal Gait Parameters of Stroke Patients Across Overground, Self Paced Treadmill, and Body-Weight Supported Treadmill Walking
Phase: NA
Conditions: Gait Impairment in Stroke Patients
Sponsor: Bangladesh University of Engineering and Technology

1 
 
Research Protocol: 
 
Spatiotemporal gait parameters of healthy and stroke patients during 
overground, self-paced treadmill, and body-weight supported treadmill 
walking. 
 
Submitted to: 
Institutional Review Board 
BUET, Dhaka-1000, Bangladesh. 
 
 
 
Principal Investigator 
Dr. Muhammad Tarik Arafat, PhD 
Professor, Department of Biomedical Engineering 
BUET, Dhaka, Bangladesh. 
 
Co-Principal Investigator: 
Dr. Mohammad Moniruzzaman 
Associate professor 
Department of Physical Medicine and Rehabilitation, Dhaka Medical College 
Hospital (DMCH), Dhaka-1205, Bangladesh. 
 
 
 
Date of Submission: 20/08/2024 

2 
 
List of Documents 
 
 
1. Annexure – A:   
a. Filled-up Ethical Clearance Application Form.  
b. Signature of Principal Investigator (s) & Co-investigator (s) with 
details address. 
 
2. Annexure – B:  
Abstract for BME Ethical Review Committee (BMEERC)   
 
3. Annexure – C: 
BMRC format for Submission of the Proposal for Ethical Approval 
 
4. Annexure – D:  
Informed consent form (English) from participants or the parent / 
legal guardian 
  
5. Annexure – E: Budget 
 
 
 
 
 
 
 
 

3 
 
ANNEXURE - A 
Application for Ethical Clearance 
 
Title of the study: Spatiotemporal gait parameters of healthy and stroke patients during 
overground, self-paced treadmill, and body-weight supported treadmill walking. 
 
Principal Investigator:  
Dr. Muhammad Tarik Arafat, Professor  
Department of Biomedical Engineering (BME), BUET, Dhaka - 1000, Bangladesh. 
 
Co-Principal Investigator(s):  
Dr. Mohammad Moniruzzaman 
Department of Physical Medicine and Rehabilitation, Dhaka Medical College Hospital (DMCH), 
Dhaka-1205, Bangladesh.          
                                          
Place of the Study/Institution(s): Biomechanics and biofluid lab, Department of Biomedical 
Engineering (BME), BUET, Dhaka - 1000, Bangladesh. 
 
Type of Study: Comparative study.   
 
Duration of Study:  6 months  
 
Total Cost: 30,000 Tk.  
 
Funding Agency: N/A. 
 
 
 

4 
 
Circle the appropriate answer to each of the following 
(If not Applicable write NA)  
 
1. Source of Population:                                                        
   (a)  Ill Participant               Yes     No  
   (b)  Non Ill Participant       Yes     No  
   (c)  Minors or persons           Yes     No   
        under guardianship    
 
2. Does the study involve?  
   (a)  Physical risks                  Yes     No   
         To the subjects   
   (b)  Social Risks                    Yes     No  
   (c)  Psychological                  Yes     No   
         Risks to subjects    
   (d)  Discomfort to                  Yes     No   
         Subjects   
   (e)  Invasion of the body        Yes     No    
   (f)  Invasion of Privacy         Yes      No   
   (g)  Disclosure of                   Yes     No   
         Information damaging to   
         Subject or others  
3. Does the study involve? 
 (a)  Use of records,                    Yes     No   
       (Hospital, medical,   
        Death, birth or other) 
 (b)  Use of fetal tissue               Yes     No   
        Or abortus 
 (c)  Use of organ or                  Yes     No   
       Body fluids  
 4. Are subjects clearly informed about?  
  (a)  Nature and                           Yes    No  
         purposes of study  
  (b)  Procedures to be                  Yes    No  
        followed including   
         alternatives used  
  (c)  Physical risks                       Yes    No  
  (d)  Private questions                     N/A  
  (e)  Invasion of the Body               N/A  
  (f)  Benefits to be Derived          Yes    No  
  (g)  Right to refuse                      Yes    No  
        to participate or   
        to withdraw from study  
  (h)  Confidential                          Yes    No  
         handling of data  
  
  (i)  Compensation                            N/A   
        where there are risks or   
        loss of working time or   
        privacy is involved in   
        any particular procedure  
5. Will signed consent form/verbal 
consent be required?  
  (a)  From Subjects                         Yes    No  
  (b)  From parent or                          N/A  
       guardian (if  subjects   
        are minors)  
6. Will precautions be                    Yes   No   
    taken to protect   
   anonymity of subjects 

5 
 
Note: If the final instrument / questionnaire is not completed prior to review, the following 
information should be included in the abstract. 
 
1. A description of the areas to be covered in the questionnaire or interview which could                  
be considered either sensitive or which would constitute an invasion of privacy. 
2. Examples of the type of specific question to be asked in the sensitive areas. 
3. An indication as to whom the questionnaire will be presented to the committee for 
review. 
 
 
We agree to obtain approval of the Ethical Review Committee for any changes involving the 
rights and welfare of subjects or any changes of the Methodology before making any such 
changes.  
 
 
 
 
                   Signature  
 
Dr. Muhammad Tarik Arafat 
Professor, Department of Biomedical Engineering (BME)  
Bangladesh University of Engineering and Technology (BUET) 
Dhaka - 1000, Bangladesh.  
 
Date:  20/08/2024  
Name of Co-investigator (S)                                                                                  Signature  
                      
 
 
 
 
 
 
 
 
 
                                                             
* Include all the Investigator, Co-Investigators. 

6 
 
ANNEXURE - B  
ABSTRACT FOR  
BME Ethical Review Committee (BMEERC) 
The Ethical Review Committee will not consider any application which does not include a specific 
abstract/summary for the committee. The abstract should summarize the study's purpose, the 
methods, and procedures to be used by addressing each of the following items. If an item is not 
applicable, please note accordingly:  
1. Describe the requirements in respect of the population and explain the rationale for using 
the population of special groups such as children, Incompetent person, or groups whose 
ability to give voluntary informed consent is questionable.  
Response: The primary aim of the study is to evaluate the differences in variability in   
spatiotemporal gait parameters of stroke patients during overground, self-paced treadmill, 
and body-weight supported treadmill walking. Stroke, while more common in older adults, 
can affect people of all ages. As a result, our study participants range in age from 18 to 75 
years, allowing us to better understand the impact of stroke across a larger age range. 
Children under the age of 18 and individuals who are unable to provide voluntary informed 
consent will be given consent from a parent or legally authorized guardian. Furthermore, 
consent will be obtained from children who are old enough to understand the study, 
ensuring that they are willing to participate. Pregnant women are not allowed to participate 
in the study due to safety concerns. The specific inclusion criteria are listed below:  
      Post-stroke patients who are able to walk and aged between 18 to 75 (not pregnant). 
 
2. Describe and assess any potential risks - physical, psychological, social, legal or other and 
assess the likelihood and seriousness of such risks. If methods of research create potential 
risks, describe other methods, if any, that were considered and why they cannot be used. 
Response: The primary aim of the study is to compare the variability in spatiotemporal 
gait parameters of stroke patients across overground, self-paced treadmill, and body-weight 
supported treadmill walking, and to identify which walking technique yields the most 
consistent and beneficial gait metrics, indicating a more stable and effective recovery. If 
the post-stroke subject is afraid of falling, an overhead harness will be used to ensure their 
safety during data collection. 
The use of the body weight support structure (BWSS), which is designed to help 
participants with balance issues, carries minimal physical risk. The structure can support 
up to 5 tons and has been tested on healthy adults weighing an average of 80 kg for up to 
4 minutes. The overhead harness is intended to provide comfort by evenly distributing 
pressure across the lumbar and thoracic regions, and it includes a thigh belt for added 
safety. There may be some psychological discomfort due to unfamiliarity with the 

7 
 
equipment or the testing environment. There are no anticipated social or legal risks in this 
study.  
 
3. Describe procedures for protecting against or minimizing potential risks and assessment of 
their likely effectiveness. 
Response: The study is designed to minimize potential risks through careful planning and 
implementation of safety measures. The primary risk mitigation strategy involves using a 
body weight support structure during data collection for stroke subjects. This structure can 
support up to 5 tons and has been tested for safety and comfort. It includes an overhead 
harness to provide support during walking. During the data collection process, participants 
will be continuously monitored by the study investigators. Any signs of physical 
discomfort, fatigue, or deterioration in condition will result in the immediate termination 
of the experimental trial. Participants unable to walk with the overhead harness or express 
discomfort will not be subjected to the experiment. 
 
4. Include a description of the methods for safeguarding confidentiality or protecting 
anonymity. 
Response: The study will implement strict protocols to safeguard the confidentiality and 
anonymity of participants. All collected data will be accessible only to authorized study 
personnel. Personal identifying information will be removed from the data after the study 
is completed. Each participant will be assigned a unique code, and only coded data will be 
used in the analysis and reporting of study results.   
 
5. When there are potential risks to the subject, or the privacy of the individual may be 
involved, the investigator is required to obtain a signed informed consent from the 
participant. For minors, informed consent must be obtained from the authorized legal 
guardian or parent of the subject. Describe consent procedures to be followed, including 
how and where informed consent will be obtained. 
(a) If signed consent will not be obtained, explain why this requirement should be waived 
and provide an alternative procedure such as a verbal consent.  
Response: Informed consent will be obtained. 
 (b) If information is to be withheld from a subject, justify this course of action.  
Response: No information will be withheld from the subject.  
(c) If there is a potential risk to the subject or privacy of the individual or loss of work time 
is involved in any particular procedure, include a statement in the consent form stating 
whether any compensation will be available.  
Response: Not applicable since there is a minimal risk of privacy and loss of work time.  

8 
 
6. If the study involves an interview, describe where and in what context the interview will 
take place. State approximate length of time required for the interview.  
Response: The study will not require an interview.  
7. Assess the potential benefit to be gained by the individual subject as well as the benefits 
which may accrue to society in general because of the work. Indicate how the benefits may 
outweigh the risks.  
Response: The study offers potential benefits to individual subjects and society, which 
outweigh the minimal risks associated with participation. After conducting the experiment, 
each participant will receive a gait analysis report. Especially, in the case of post-stroke 
patients, the gait impairment can be evaluated by this report. Again, In Bangladesh, there 
is a scarcity of gait analysis facilities. Moreover, the study could serve as a foundation for 
further research in gait analysis within Bangladesh that may inform and enhance 
therapeutic practices, leading to better treatment and rehabilitation strategies for post-
stroke patients. In the long run, the establishment of gait analysis research can have a 
significant public health impact, improving the quality of care for individuals with gait 
abnormalities. The potential risks associated with the study are minimal and include minor 
physical discomfort or fatigue during the gait analysis.  
8. In case of an experimental drugs, provide information about its status of registration for 
open sale in Bangladesh and in other developed countries.  
Response: N/A.  
9. For experimental 'new' drugs* which are not registered in Bangladesh provide full 
information about the toxicity studies carried out in animals or human volunteers. 
Published papers on this regard shall be annexed.  
Response: N/A.  
10. If placebo is to be used justify its uses and why the study cannot be done without its use. 
Response: N/A.  
11. If an experimental 'new' drug* is to be used give a statement regarding its sponsorship and 
the conditions for such sponsorship.  
Response: N/A.  
12. State if the activity requires the use of records (hospital, medical, birth, death or other), 
organs, tissues, body fluids, the fetus or the abortus.  
Response: Yes. The study will require the use of medical records, including stroke type, 
the duration since the stroke occurred, paretic side by stroke, hospital admission and release 
dates etc.  

9 
 
ANNEXURE - C 
Project Title: Spatiotemporal gait parameters of healthy and stroke patients during overground, 
self-paced treadmill, and body-weight supported treadmill walking. 
Summary:  
This study aims to collect and analyze spatiotemporal data from stroke patients using an in-house 
gait analysis setup. Each walking modality-overground, self-paced treadmill, and body-weight 
supported treadmill provides distinct advantages and challenges. Overground walking simulates 
natural conditions but lacks mechanical support; self-paced treadmill walking provides a 
controlled environment with adjustable speed; and body-weight supported treadmill walking 
reduces lower extremity pressure and the risk of falling. A locally made body weight support 
structure (BWSS) is used for fall prevention in hemiparetic patients during data collection. The 
BWSS includes: Hand winch system with locking mechanism, Double pulley system, An overhead 
harness, and A 10 ft Stainless steel wire (loading capacity=5 ton). For Overground, data collection 
is done using two force plates positioned in the middle of a linear pathway, an 8-camera video 
monitoring system, and AcqKnowledge software is used for data analysis. Data collection from 
the self-paced treadmill and body-weight supported treadmill also occur through the video 
monitoring system. Data collection will adhere to standard protocols to ensure safety and accuracy. 
Participants will walk along the pathway, and gait data will be recorded using the force plates and 
video system. By analyzing gait parameters such as step length, stride length, cadence, gait speed, 
and the duration of stance and swing phases, the study aims to identify which modality offers the 
most consistent and stable gait patterns, indicating improved motor control and coordination. 
Introduction:  
Stroke is the leading cause of disability worldwide, affecting the lives of millions of people. One 
of the most debilitating effects of stroke is impaired gait, which impairs mobility and independence 
[1]. It is especially prevalent in low- and middle-income countries such as Bangladesh. Stroke is 
the third leading cause of death from non-communicable diseases in Bangladesh, putting a 
significant burden on both individuals and the healthcare system. Stroke prevalence in Bangladesh 
is around 11.39 per thousand people, with higher rates in rural areas and among elderly males [2]. 
Gait abnormalities are experienced by about 80% of stroke survivors, and they can significantly 
impair their daily activities and overall quality of life [3]. The significant number of disability-
adjusted life years (485 per 10,000 people) lost due to stroke severely impacts the nation's economy 
[4]. Despite the high occurrence of disability due to stroke in Bangladesh, there are significant 
limitations in analyzing the gait characteristics of stroke patients. Gait rehabilitation uses a variety 
of walking modalities, such as body weight supported treadmill walking, self-paced treadmill 
walking, and overground walking. Every modality has particular benefits and drawbacks. The most 
natural kind of gait training is provided by walking on terrain that closely resembles actual walking 
conditions. However, because of the unpredictable nature of the environment and the lack of 

10 
 
mechanical support, it can be challenging for stroke patients [5]. Self-paced treadmill walking 
provides a controlled environment in which the patient's speed can be adjusted based on their 
abilities, allowing for a consistent walking rhythm and feedback [6]. This modality is useful for 
strengthening gait patterns and increasing endurance. However, body weight supported treadmill 
walking allows the patient to partially offload their weight, which lessens the pressure on their 
lower extremities and improves safety by lowering the chance of falls [7]. Variability in gait 
parameters such as step length, stride length, cadence, gait speed, and the duration of the stance 
and swing phases is an important aspect of gait analysis. High variability in gait frequently 
indicates instability and inefficiency, which are undesirable outcomes in rehabilitation. Lower 
variability, on the other hand, indicates more consistent and stable gait patterns, implying 
improved motor control and coordination. 
 
Objectives:  
In this study, we aim to evaluate the gait differences among three different waking modalities with 
respect to spatiotemporal gait parameters. This will be achieved through a comparative analysis of 
spatiotemporal data between those groups. To ensure the safety of the subjects, the data collection 
protocols will be strictly followed, incorporating already tested procedures that have shown no 
probable risk. The BWSS has been tested with healthy individuals and is manufactured using 
widely available components in Bangladesh. The objectives of the study are as follows:   
• Study objectives: To evaluate the variations in spatiotemporal gait parameters of three 
different waking modalities and analyze and determine which walking technique provides 
the most reliable gait metrics, suggesting a more stable and possibly advantageous recovery 
outcome. 
 
• Study Hypothesis: We hypothesize that body weight supported treadmill walking will 
exhibit the least variability in spatiotemporal gait parameters compared to overground 
walking and self-paced treadmill walking. This suggests that BWST provides a more 
controlled environment, promoting more consistent and reliable gait patterns, which may 
translate to a more stable and potentially advantageous recovery outcome for individuals 
with stroke. 
Rationale:  
Stroke is a leading cause of disability worldwide, significantly impairing mobility and increasing 
the risk of falls. In Bangladesh, stroke is not only a major health concern due to its high prevalence 
and mortality rate but also has a substantial economic impact, with a large number of disability-
adjusted life years lost. Despite the high incidence of stroke and the resultant gait impairments, 
there is a significant gap in the availability of gait analysis in Bangladesh. Most existing studies in 

11 
 
the region rely on traditional, observational methods that often provide inaccurate data and focus 
primarily on spatiotemporal parameters, neglecting crucial biomechanical insights. 
Gait analysis, which measures characteristics such as stride length, step time, and swing time 
(spatiotemporal parameters), is critical for evaluating gait quality and monitoring rehabilitation 
progress. Overground walking analysis is widely regarded as the gold standard [8]. However, 
environmental factors such as uneven surfaces, obstacles, and a fear of falling can cause data 
variability [9]. Treadmill walking provides a controlled environment and facilitates data collection, 
but the question remains: which environment yields the most reliable and informative data for 
post-stroke gait assessment and rehabilitation planning? 
This study fills this knowledge gap by investigating the variability of spatiotemporal gait 
parameters across three walking environments: 
• Overground walking: Represents real-world walking but can be influenced by 
environmental factors, as previously stated. 
• Self-paced treadmill walking provides a controlled environment, but may not fully 
challenge balance and coordination, potentially yielding less informative data on these 
aspects of gait. 
• Body weight supported treadmill walking (BWST): Provides partial support, potentially 
promoting more consistent gait patterns due to lower balance demands, which may be 
beneficial for initial gait training. 
Understanding the variability of gait parameters across these environments is important for several 
reasons. Identifying the environment that produces the most consistent and reliable gait data 
enables researchers and clinicians to select the best assessment method for post-stroke patients. 
This can result in more accurate assessments of gait impairments and progress during 
rehabilitation. Therapists can tailor gait training programs to specific environments based on 
rehabilitation objectives and individual needs. For example, because of its supportive nature, 
BWST may be a useful tool for initial training, whereas overground walking practice becomes 
more critical as balance and coordination improve. Additionally, it will provide a reliable and safe 
method for gait analysis that can be widely adopted in Bangladeshi healthcare setting and lay the 
groundwork for future research and clinical applications in gait analysis and rehabilitation for 
stroke patients in Bangladesh. Ultimately, this study seeks to improve the assessment and 
management of gait impairments in stroke patients, contributing to better rehabilitation outcomes 
and enhancing the quality of life for affected individuals. 
 
 
 
 

12 
 
Methodology: 
Study design 
Comparative study. 
 
Patient Selection 
Inclusion criteria: 
• Participants must be between 18 to 75 years old. 
• More than 1- month post stroke patient. 
• Participants must be able to walk with or without assistance. 
• Patients including both the male and female. 
• Participants must be able to provide informed consent to participate in the study. 
Exclusion Criteria: 
• Severe cognitive or communicative disorders. 
• Significant joint malposition. 
• Psychological, cognitive dysfunction, and any other neuromuscular problem. 
• Pregnant women will be excluded to avoid any potential risks to the mother and fetus. 
• Unstable cardiovascular disease like congenital heart disease, deep vein thrombosis, 
coronary heart disease, previous history of heart attack or heart failure. 
 
Data collection procedure:  
Participants will be selected based on pre-determined inclusion criteria to ensure they fit for the  
study. Data will be collected through face-to-face interview using a pretested semi-structured 
questionnaire and informed verbal consent will be taken prior to interview. All the participants 
demographic information (age, weight, height, etc.) will be collected. Participants evaluated by 
Berg Balance test and Time Up & Go (TUG) test questionnaire form. All participant names have 
been properly defined to make sure confidentiality. After that the participants will be instructed to 
walk in their natural and comfortable manner. All participants will undergo a familiarization trial 
to get comfortable with the experimental setup and procedures. Then, participants will perform 
linear walking during two consecutive trials. Then take 2 minutes rest for treadmill walking after 
that again take 2 minutes rest for BWSTW.  Data will be collected using a force plate and an 8-
camera video monitoring system on all three walking modalities. The collected spatiotemporal 
data will be analyzed by statistical methods to identify differences among those modalities. 
Specific focus will be on key spatiotemporal parameters such as step length, stride length, cadence, 
gait speed, and the duration of the stance and swing phases use as important aspects of gait analysis 

13 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
              
                                                    Figure: Flow chart of study plan 
Selecting a subject based on 
the inclusion criteria 
Collect Barg Balance score, 
MAS score, TUG score  
Collecting subject 
demographic information 
(counterbalancing) 
Overground Walking  
Self-paced treadmill 
walking  
Body Weight Supported 
Treadmill Walking  
Participants will be 
instructed to walk at their 
natural and comfortable 
manner  
Participants will be 
instructed to walk at their 
natural and comfortable 
manner  
Participants will be 
instructed to walk at their 
natural and comfortable 
manner  
• Participant will perform walking 3 minutes 
walking for 3 trials.  
• Data will be collected using force plate and 
video monitoring system. 
Spatiotemporal parameter are extracted from 
recorded data 
Statistical Analysis 

14 
 
Phase-3-Extended Study ():  
The aim of this phase of study is to compare the Spatiotemporal parameter among different waking 
modalities. The standard protocols will be followed while conducting experiment, in the 
Department of Biomedical Engineering (BME), BUET. The various aspect of this final and most 
important component of the study are described below:  
Sample Size calculation: In this comparative study, the gait velocity in between different waking 
modalities is considered as the primary parameters. The following formula may use for calculating 
the sample size for each group of the trial: 
Sample size,  N= 
2.𝜎2(𝑍1−𝛽+𝑍1−𝛼/2)
2
𝑑2(𝑘−1)
  ……………………………………………………………(i) 
Where, 
N 
=  
Required sample size  
d  
= 
Difference in means of two group (effect size)  
σ  
=  
SD  
                        k          =          is the number of groups being compared. 
Z 1-β  =  
It is the desired power  
Z1-α/2 =  
Critical value and a standard value for the corresponding level of 
confidence. (At 95% CI it is 1.96)  
To estimate the sample size, we considered the mean difference of the velocity of the post stroke 
patient to be at least 0.17 with a standard deviation of 0.3. We estimated that 24 individuals would 
be needed to satisfy the comparative studies between three groups, based on the statistical power 
of 80%, at a two-sided alpha level of 0.05. The statistical formula (i) used for the comparative test 
[10]. Considering dropouts and left-against-medical advice (LAMA) cases, sample size 𝑁 = 25 
will be considered. Thus, a total of 25 subjects will be considered for the equal allocation of this 
study. The different aspects of the study are summarized in Table I. 
Table 1: Summary of the comparative study between healthy and post stroke individuals 
Aspect of the study 
Description 
Study Type 
Comparative  
Design 
Comparative study 
No of subjects 
25 
Objective 
Evaluate the variations in spatiotemporal gait parameters of those 
waking modalities. 
Study Population 
Inclusion Criteria for post-stroke patients: 

15 
 
• Participants must be between 18 to 75 years old. 
• More than 1- month post stroke. 
• Participants must be able to walk with or without assistance. 
• Patients including both the male and female. 
• Participants must be able to provide informed consent to 
participate in the study. 
Exclusion Criteria for post-stroke patients: 
• Severe cognitive or communicative disorders. 
• Significant joint malposition. 
• Psychological, 
cognitive 
dysfunction, 
and 
any 
other 
neuromuscular problem. 
• Pregnant women will be excluded to avoid any potential risks to 
the mother and fetus. 
• Unstable cardiovascular disease  
Procedure 
Post stroke group: 
• Giving instruction  
• Randomly assigning patients to all the modalities 
• Data collection through force plate and video cameras 
• Extracted spatiotemporal parameters from recorded data 
Outcomes 
Primary Outcome: 
• Gait velocity 
Secondary Outcome: 
• Step length 
• Stride length 
• Cadence 
• Stance and swing phases duration 
• Single and double support time  
• Ground reaction force 
Data Collection 
Data collected before trial: 
• Patient clinical condition  
• Time after stroke and before data collection 
• Duration of therapy/rehabilitation 
Data collected during walking: 
• Force plate data 
• Video monitoring data 
Data analysis 
• Comparative test between the primary outcome of three group 
• Wilcoxon sign rank test & a paired sample t test 
•  Interclass correlation coefficient between those group 
• Mean difference and standard deviation between those group 

16 
 
 
References 
 
[1]  H. H. e. a. Kyu, "Global, regional, and national disability-adjusted life-years (DALYs) for 
359 diseases and injuries and healthy life expectancy (HALE) for 195 countries and 
territories, 1990–2017: a systematic analysis for the Global Burden of Disease Study 
2017," GLOBAL HEALTH METRICS, vol. 392, no. 10159, pp. 1859-1922, 2018.  
[2]  A. T. M. H. H. K. D. M. Md Badrul Alam Mondal, "Prevalence and risk factors of stroke in 
Bangladesh: A nationwide," eNeurologicalSci, vol. 28, no. 100414, 2022.  
[3]  B. H. Dobkin, "Rehabilitation after Stroke.," The New England Journal of Medicine, vol. 
16, no. 352, p. 1677–1684, 2005.  
[4]  M. N. e. a. Islam, "Burden of stroke in Bangladesh," International journal of stroke, vol. 8, 
no. 3, pp. 211-213, 2013.  
[5]  F. C. A. P. Peter Langhorne, "Motor recovery after stroke: a systematic review," The 
Lancet Neurology, vol. 8, no. 8, pp. 741-54, 2009.  
[6]  M. M. v. d. K. J. H. L H Sloot, "Self-paced versus fixed speed treadmill walking," Gait 
Posture, vol. 39, no. 1, pp. 478-84, 2014.  
[7]  J. M. Hausdorff, "Gait dynamics, fractals and falls: finding meaning in the stride-to-stride 
fluctuations of human walking," Hum Mov Sci, vol. 26, no. 4, pp. 555-89, 2007 .  
[8]  V. A. M. B. M. B. G. R. E. M. M. C. C. N. M. M. D. B. Francesco Ferrarello, "Tools for 
observational gait analysis in patients with stroke: a systematic review," Phys Ther, vol. 93, 
no. 12, pp. 1673-85, 2013.  
[9]  P. Kooncumchoo, "Gait Improvement in Chronic Stroke Survivors by Using an Innovative 
Gait Training Machine: A Randomized Controlled Trial," International Journal of 
Environmental Research and Public Health, vol. 19, no. 1, p. 224, 2021.  
[10] S. K. e. a. Sharma, "How to calculate sample size for observational and experimental 
nursing research studies," National Journal of Physiology, Pharmacy and Pharmacology, 
vol. 10, no. 1, pp. 1-8, 2020.  
 
 

17 
 
ANNEXURE - D 
INFORMED CONSENT FORM (ENGLISH) 
Project Title: Spatiotemporal gait parameters of healthy and stroke patients during overground, 
self-paced treadmill, and body-weight supported treadmill walking. 
Principal Investigator: 
Dr. Muhammad Tarik Arafat, Professor  
Department of Biomedical Engineering (BME), BUET, Dhaka - 1000, Bangladesh. 
Location: 
Biomechanics and biofluid lab, Department of Biomedical Engineering (BME), BUET, Dhaka - 
1000, Bangladesh. 
Interviewer details: 
The interview will be conducted by study investigators at the lab. 
Purpose of the Study: 
The purpose of this study is to compare the variability of spatiotemporal gait parameters in stroke 
patients across three different walking modes: overground walking, self-paced treadmill walking, 
and body-weight supported treadmill walking. By collecting and analyzing detailed gait data from 
stroke patients using these methods, the study hopes to determine which walking technique 
provides the most reliable and consistent gait metrics, indicating improved motor control and 
coordination. Lower variability in these parameters indicates a more stable and favorable recovery 
outcome. The findings will include evidence-based recommendations for optimizing gait 
rehabilitation programs, as well as information for healthcare professionals about the benefits and 
limitations of each walking modality. Finally, the study aims to improve rehabilitation strategies 
and recovery outcomes for stroke patients. 
Types of participation of the study respondents:  
If you agree to participate in this study, you will be required to provide information on your 
demographics and medical history. 
Duration of study:  
The study will be performed for one hour. 
Procedures of the study:  
The procedure of this study involves the following steps: 

18 
 
1. Demographic (including age, weight, height) and clinical information will be collected 
from you. 
2. You will be instructed to walk as naturally as possible by looking at the opposite wall. 
3. A randomized trial will be conducted to acclimate you to the experimental setup. 
4. When the investigator will instruct you, you need to start walking. Your gait data will be 
collected using two force plates and an 8-camera video monitoring system on all three 
waking modalities. 
5. You need to complete at least three walking trials. 
6. Your GRF data and video footage will be examined to ensure accurate foot contact with 
the force plates.  
7. If your collected data are distorted by noise or any other things, the investigator will ask 
you to walk again. 
8. If you have any discomfort wearing body harness, or feel any kind of fatigue during 
walking you should immediately let the study investigators know. 
Potential benefits: 
The study offers significant potential benefits for both for you and society as a whole. Individually, 
you will receive your gait analysis report which will help the doctors to understand your gait 
impairments. The use of a BWSS ensures your safety during data collection.  
Risks, hazards and discomforts: 
The study is designed to be as safe as possible. Wearing the harness at 1st time may cause 
discomfort for you. Since you’re are a stroke patient, you may experience anxiety during the gait 
analysis due to the unfamiliar equipment. Additionally, you may feel fatigue or exhaustion from 
the walking trials 
Reimbursements: 
You will not be reimbursed for any medical expenses. However, if any health hazard occurs due 
to the participation in this study, adequate steps will be taken by the study investigators. Again, if 
you are unable to afford the travel expenses while attending the study session, the reimbursement 
will be offered to cover the expense. This reimbursement will be provided at the conclusion of 
your participation. 
Confidentiality: 
The confidentiality of about your information will be rigorously maintained throughout the study. 
Personal identifying information will be collected from you initially for contact but will be 
removed from the dataset after data collection to ensure anonymity. You will be assigned a unique 
identification code, which will be used in all data analysis and reporting. 
 

19 
 
Rights to withdraw from participation: 
Participation in this study is voluntary and you may withdraw from the study for any reason at any 
time. You will not be penalized in any way for declining to take part in or withdrawing from the 
study. If you decide to withdraw, the gait data collection procedure will be discontinued. 
 
 
 
I am consciously and voluntarily participating in the above research study entitled 
“Spatiotemporal gait parameters of healthy and stroke patients during overground, self-
paced treadmill, and body-weight supported treadmill walking.”. I understand that I will not 
be given any financial benefit for my participation. The doctors assured me that participating in 
this study would not harm me physically or mentally and that at any time I would be able to 
voluntarily withdraw from the study and my treatment would have no effect on it. All my 
information will be kept confidential. 
[Photographing / Video recording] 
Photographing/video recording of a participant will be used to visualize experimental setups for 
the purposes including publication, grant application and public relations. Private information such 
as the participant’s name will not be made available. 
 
Do you agree with Photographing / Video recording during the experiment? 
 
 
 
 
 
Yes 
 
 
No 
 
During any part of the experiment, whenever participants feel discomforts beyond tolerance, trials 
can be stopped. 
Name of participant:  
 
 
Signature/Thumb print of the participant:  

20 
 
Name of the witness:  
Signature of the witness:  
Name of the interviewer: 
Signature of the interviewer: 
[*please note: Where the participant/s are aged under 18, separate parental consent is required; where the 
participant/s are unable to answer for themselves due to disability, parental or guardian consent may be 
required.] 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

21 
 
                              INFORMED CONSENT FORM 
 
(English Version) 
 
Spatiotemporal gait parameters of healthy and stroke patients during 
overground, self-paced treadmill, and body-weight supported treadmill 
walking. 
 
I am giving consent to take part in the above-mentioned research study of Department of 
Biomedical Engineering, BUET. The nature of the research has been explained to me. 
 
I am ensuring that, 
 
I am taking part in this study voluntarily …………………….     Yes         No 
 
I am voluntarily giving my time to the research ….………….     Yes         No 
 
I am giving my permission to let the researchers  
of BME, BUET to keep the consent form as rec ………………   Yes        No 
 
 
and I have been allowed to ask questions about this study and my participation in it. I understand 
that all my personal information will be kept confidential, and no part of this information that 
might reveal my identity will be published. I also understand that I can refuse to take part in this 
study any time I want, and I will not be accounted for any questioning or harm for my refusal. 
 
 
Name of Participant ……………………    Sign of Participant ………………………. 
 
Name of Investigator …………………..    Sign of Investigator ……………………… 
 
Date.................... 
 
[*please note: If the participants are unable to answer for themselves due to disability, 
guardian consent may be required.] 
 
 
 

22 
 
 
                    Case Report Form 
Project Title: Spatiotemporal gait parameters of healthy and stroke patients during overground, 
self-paced treadmill, and body-weight supported treadmill walking. 
Participant Information 
1. 
Patient’s name 
 
Age 
 
2. 
Patient ID 
 
Gender 
☐ Male ☐ Female 
3. 
Address 
 
Contact no. 
 
4. 
Height (cm) 
 
5. Weight (kg)   
Date of Stroke 
 
6. 
Type of Stroke 
☐ Ischemic    ☐ Hemorrhagic 
7. BMI 
 
8. 
Affected Side 
☐ Right          ☐ Left 
 
 
 
Medical History 
9. 
Hypertension 
☐ Yes ☐ No 
10.Diabetes Mellitus 
☐ Yes ☐ No 
11. Heart Disease 
☐ Yes ☐ No 
12. Previous Strokes 
☐ Yes ☐ No 
13. Peripheral 
Artery Disease 
☐ Yes ☐ No 
14. Chronic Kidney 
Disease 
☐ Yes ☐ No 
15. Smoking 
☐ Yes ☐ No 
16. Alcohol Use 
☐ Yes ☐ No 
17. BP 
 
18.Heart Rate 
 
Number of Previous Strokes 
 
Gait Analysis Information 
19. Date of Gait Analysis 
 
20. Time Since Stroke (months) 
 
21. Balance Test (Berg 
Balance Scale) 
Score: _______/56 22. Muscle Strength 
(MRC Scale) 
Right Leg: _____/5 
Left Leg:    _____/5 
23. Spasticity (Modified 
Ashworth Scale) 
Right Leg: _______/4 
Left Leg:   _______/4 
 
 
Gait Analysis Parameters 
24. Walking Speed 
(m/s) 
 
25. Cadence (steps/min) 
_______ 

23 
 
 
 
Completed by: 
Name of Investigator 
Signature 
Date 
 
 
 
 
 
 
 
 
 
26. Stride Length 
(cm) 
Right Leg: _______ 
Left Leg:   _______ 
27. Step Length (cm) 
Right Leg: ______ 
Left Leg: _______ 
28. Gait Cycle Duration (s) 
         _______ 
 
 
29. Stance Phase (% 
of gait cycle) 
Right Leg: _______ 
Left Leg:   _______ 
30. Swing Phase (% of 
gait cycle) 
Right Leg: ______ 
Left Leg: _______ 
31. Double Support Time (s) 
_______ 
32. Single Support Time (s) 
_______ 
33. Vertical GRF (N) 
Paretic Leg: _______ 
Non- paretic Leg:   
_______ 
34. Anteroposterior 
GRF(N) 
Paretic Leg: 
______ 
Non- paretic Leg:   
______ 
35. Mediolateral GRF(N) 
Paretic Leg: _______    non-paretic Leg:   _______ 
Observational Gait Analysis & Functional Outcome Measures 
36. Initial Contact 
☐ Heel              ☐ Flat Foot               ☐ Toe 
37. Midstance 
☐ Normal         ☐ Hyperextension   ☐ Flexed Knee 
38. Toe-off 
☐ Normal         ☐ Delayed                 ☐ Early 
39. Symmetry 
☐ Symmetrical       ☐ Asymmetrical 
40. Assistive Devices Used 
☐ None     ☐ Cane    ☐ Walker    ☐ Other: __________ 
41. Timed Up and Go 
(TUG) Test (seconds) 
 
42. 10-Meter Walk Test 
(seconds) 
 

24 
 
Annexure – E 
Budget 
The total budget for the proposed study is Tk. 30,000/-. The budget of the project is provided 
below: 
No Description 
Unit 
Unit Cost 
(BDT) 
Qty. 
Cost (BDT) 
1 
Reimbursement -Travel 
Cost of participants 
L.S. 
1000 
25 
25,000 
2 
Miscellaneous Expenses 
L.S. 
4000 
1 
4000 
3 
Contingency (5%)  
L.S 
 1000 
1 
1000 
                Total Cost 
 
 
 
30,000 
 
Grand Total: Tk. 30,000/-