Usefulness of Insole-type Gait Analyzer in Collecting Gait Data From Patients With Gait Disturbance
Phase: NA
Conditions: Gait Disorders, Neurologic
Sponsor: Yonsei University

 
 
 
Cover page for ClinicalTrials.gov 
 
Name of the document: 
Study protocol and Statistical Analysis Plan 
 
Official Title of the Study: 
Analyzing Gait Pattern Using Insole-type Gait Analyzer in Patient with 
Gait Disturbance 
 
NCT number 
NCT06442982 
 
Date of the document: 
February 4, 2025 
 
 

 
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Prospective Clinical Study Protocol 
 
1. Title, stage, protocol identification number, revision history, etc. 
- Title: Analyzing Gait Pattern Using Insole-type Gait Analyzer in Patient with Gait Disturbance 
- Stage: phase 4 
 
2. Summary of study plan 
Study objective 
We explore the usefulness of information from insole-type gait analyzer in adults 
with subjective gait and balance disorders. 
Study design overview 
We analyze the collected data from gait wearing insole-type gait analyzer for 
subjective gait and balance disorders. 
Drugs/medical devices for 
clinical trials 
Insole-type gait analyzer 
Target number of subjects 
and calculation basis 
600 adults with subjective gait or balance disorders 
This study investigates whether clinically significant data could be obtained using 
insole-type gait analyzer, with the number of subjects determined considering 
clinical conditions. 
Inclusion 
and 
exclusion 
criteria 
1. Inclusion criteria 
1) adults aged 19 and over (based on the age on their national ID at the time of 
consent) 
2) adults complaining subjective gait or balance disorders 
3) individuals who voluntarily agree to participate in the study and sign a consent 
form 
 
2. Exclusion criteria 
1) individuals unable to walk independently on flat ground for more than 6 
minutes 
2) individuals who cannot read ordinary print with glasses due to visual reasons 
3) individuals who cannot understand conversation even with a hearing aid due 
to auditory reasons 
4) individuals with clinically significant disorders in the cardiovascular, 

 
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gastrointestinal, respiratory, or endocrine systems 
5) individuals considered clinically unsuitable for the trial by the trial manager or 
person in charge based on significant medical findings. 
Study Methods 
After obtaining consent 
- A history survey, a sarcopenia questionnaire, and the International Physical 
Activity Questionnaire (IPAQ) are conducted. 
- The Timed up and go test is performed wearing the Insole-type gait analyzer 
evaluation variable 
As the purpose is data collection, no evaluation variables are set in this study 
Data analysis and statistical 
methods 
This study evaluates the validity of data collected by the insole-type gait analyzer 
but does not conduct data analysis and statistical analysis 
 
3. Study background and theoretical basis 
 Gait and balance disorders are common symptoms in the elderly, with reports indicating that 35% of 
those over 70 years old exhibit these issues. Gait and balance are maintained through complex 
interactions involving the musculoskeletal system, various sensory functions with proprioceptors, and 
cognitive attention. These disorders are not only closely linked to degenerative brain diseases such as 
dementia and Parkinson's disease but also to musculoskeletal disorders like osteoarthritis and spinal 
stenosis, serving as indicators for disease prognosis and functional status assessment. Moreover, gait and 
balance disorders can occur in the absence of medical conditions due to aging, potentially leading to 
increased falls, complications, and higher personal and societal costs. Therefore, early diagnosis and 
assessment of these disorders are crucial in geriatric medicine.  
Traditionally, expensive specialized equipment such as cameras and pressure sensors installed in 
controlled environments, have been used to assess various kinematic changes during the gait cycle, such 
as stride variations and bilateral stepping differences. However, these tools have practical limitations in 
clinical settings. Although insole-type gait analyzer have been developed and commercialized, they have 
only been tested on healthy adults.  Their usefulness in patients with gait disorders remains unverified. 
This study aims to evaluate the usefulness of insole-type gait analyzer in adults with subjective gait and 
balance disorders by analyzing the collected data during gait. 
 
4. Purpose of the study 

 
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We explore the usefulness of information from insole-type gait analyzer in adults with subjective gait and balance 
disorders. 
 
5. Risk/benefit analysis 
This study involves participants wearing non-intrusive devices during walking, posing minimal medical risk. To 
minimize the risk of potential falls during assessments, participants will walk indoors under the supervision of 
examiners. 
Participants will receive information about stride length and pressure changes in both feet during walking. The 
accumulated data could be utilized in future research related to disease treatment and prognosis, contributing to 
advancements in medicine and the improvement of patient care. Therefore, the benefits from this study are expected 
to outweigh the potential risks." 
 
6. Target number of subjects and calculation basis 
 This study investigates whether clinically significant data could be obtained using insole-type gait analyzer. 
Considering clinical conditions, the target sample size has been determined as 600 participants. 
 
7. Subject Inclusion/exclusion criteria 
1) Inclusion criteria 
(1) adults aged 19 and over (based on the age on their national ID at the time of consent) 
(2) adults complaining subjective gait or balance disorders 
(3) individuals who voluntarily agree to participate in the study and sign a consent form 
 
2) Exclusion criteria 
(1) individuals unable to walk independently on flat ground for more than 6 minutes 
(2) individuals who cannot read ordinary print with glasses due to visual reasons 

 
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(3) individuals who cannot understand conversation even with a hearing aid due to auditory reasons 
(4) individuals with clinically significant disorders in the cardiovascular, gastrointestinal, respiratory, or endocrine 
systems 
(5) individuals considered clinically unsuitable for the trial by the trial manager or person in charge based on 
significant medical findings. 
 
8. Information and management of clinical investigational drugs/medical devices 
 The information and management methods of the medical device used in this study are as follows. 
1) Insole-type gait analyzer 
(1) Item name: Gait analysis system 
(2) Classification number: A30110.01 
(3) Packaging unit: 1 set 
(4) Medical device grade: Grade 1 
(5) Model name: mobiCARE-MC100 
(6) Manufacturer: Gilon Co., Ltd. 
(7) Permit number: Manufacturing Report No. 20-1753 
(8) Principle of operation and appearance 
 
(9) How to use and precautions - refer to the attached document 

 
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2) Device management 
Medical devices used in this study are managed in a designated location (Rehabilitation Function Testing Room 
on the 2nd floor of Yongin Severance Hospital) in accordance with the precautions for use and storage method. 
(Refer to attached document) 
 
9. Study design (test group·control group, allocation, blinding and flow chart, etc.) 
 This study aims to explore the usefulness of collected data and does not establish a control group. Patients with 
subjective gait and balance disorders will wear insole-type gait analyzer and walk, then the collected data will be 
examined." 
 
10. Study Method 
1) Screening method 
The examiner asks about the subject's underlying symptoms and signs and check vital signs to ensure that the 
subject is medically stable and to determine whether the subject can walk independently on flat ground 
 
2) Korean version of Sarcopenia Screening Questionnaire 
Questionnaire that evaluates the decrease in muscle strength and functional performance along with a decrease 
in muscle mass and it is highly related to aging and chronic diseases. The evaluation method is conducted by 
having the examiner ask the subject about the following questionnaire, and the scores for the answers are 
recorded. 
It consists of 5 questions, and each question is scored 0-2 points. The higher the score, the higher the risk of 
sarcopenia. If the score is 4 or higher, sarcopenia may be suspected. 

 
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3) Korean version of the International Physical Activity Questionnaire (K-IPAQ) 
 Tests that assess various aspects of an individual's daily physical activity16 and it can provide information about  
activity level. The examiner questions the subject based on the questionnaire below, records related information, 
calculates the total activity time and intensity, and classifies it as 'low', 'medium', and 'high'. 

 
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4) Timed up and go test (TUG) 
The participants will wear insole-type gait analyzer and undergo the Timed Up and Go test. 
The above test assesses walking speed along with balance ability during walking, and this is performed as 
follows. 
a) A 46 cm high armrest chair, a color cone is placed at a distance of 3 meters from the chair and the subject is 
instructed to sit on the chair. 
b) In the preparation phase, the subject leans against the chair backrest and places his/her arms on the armrests, 
then stands up on the instruction "Start", walks 3 meters, turns around the color cone, returns to the starting 
point and sits down on the chair. 
 
5) Data Verification 
 The measurement values of the accelerometer and pressure sensors recorded in the insole-type gait analyzer will 
be examined to determine the presence of missing or outlier data. We will explore the data collection frequency 
and analysis methods to extract clinically significant data. 
 

 
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11. Study procedures and evaluation 
Phase 
Screening/ 
assessment 
week 
1 
written consent 
O 
Selection/exclusion criteria 
O 
Demographic information and 
antecedent history 
O 
Gait assessment  
O 
 
12. Criteria for stopping and dropping out of the study 
1) Termination and early suspension 
○ When a subject participating in the study withdraws their consent before the study ends 
- If consent is withdrawn, the study participant’s information collected up to that point is destroyed. 
2) Dropout 
○ If a subject continuously agrees to participate in the study but wishes to terminate their participation early due 
to personal reasons. 
- Reconfirm the voluntary intention of the study participant to ensure the study does not correspond to early 
discontinuation. If the participant still intends to provide information to the study, any information collected up to 
the point of withdrawal will be anonymized and can be used for the study. 
 
13. Safety evaluation criteria, evaluation methods, and reporting methods, including adverse 
reactions 
1) In order to ensure the safety of study participants, this study plans to have the s conduct monitoring and evaluate 
safety as a safety inspector. 
(1) As a observational study with little room for invasive intervention such as the need for separate procedures, the 

 
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risk level of the study is low, so monitoring will be conducted once a year under the supervision of the principal 
investigator, and the completeness of the data will be ensured by comparing the supporting documents, CRF, and 
protocol, and the safety data of the study participants will be reviewed. 
(2) Participants in the study can decide to stop participating at any time if they feel uncomfortable with the study, 
and the principal investigator or study manager fully explains and confirms this to the participant when obtaining 
consent. 
2) In the event of a violation or deviation from this study, the circumstances of the occurrence, the researcher's 
actions in response, and measures to prevent recurrence will be promptly reported to the IRB in writing. 
- If the subject becomes suspicious or a new incident occurs during the evaluation, immediate treatment and 
observation will be provided, the cause will be thoroughly examined, and treatment will be provided according to 
the hospital's standard procedures. This will also be reported during the interim report and written in the study 
paper. However, this study did not calculate study costs for additional treatment costs because it was judged that 
the possibility of future side effects was low. 
 
14. Data analysis and statistical considerations 
This study evaluates the validity of data collected by the insole-type gait analyzer but does not conduct data 
analysis and statistical analysis 
 
15. Measures to protect personal information and maintain confidentiality of study data 
1) Protection of the subject’s identity 
When seeking consent for study, the study is explained to the subject and consent is obtained in an independent 
space in the counseling room within the outpatient department of the Rehabilitation Medicine Department. 
All information collected from this study will undergo a deidentification process to ensure that the personal 
information of participants remains anonymous and is not disclosed to anyone other than the research team 
involved in the study. Measures will be taken to securely manage personal information to prevent exposure. The 
process of deidentification will only be reversed if necessary for the individual's treatment-related purposes, with 
strict limitations in place. 
 
2) Confidentiality of study materials 

 
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In the case of documentary data, it will be kept in a locked device to prevent it from being exposed to others, 
stored on a computer with restricted access, and managed by the researcher in charge. 
 
3) Preservation of records 
Study-related data are stored for 3 years in accordance with the Enforcement Rules of the Bioethics Act (Human 
subject researchers must keep records pursuant to Paragraph 1 for 3 years from the end of study), and among 
documents that have expired the retention period, subject related personal information shall be destroyed in 
accordance with Article 16 of the Enforcement Decree of the Personal Information Protection Act. However, if storage 
of the data is necessary for follow-up study, record accumulation, etc., the retention period must be extended after 
deliberation by the institutional committee. 
 
16. Management, storage, and disposal measures when collecting human materials, genetic 
information, etc. 
 No human specimens or genetic information are collected in this study. 
 
17. Subject recruitment method and consent procedure 
After approval from the Yongin Severance Hospital IRB, among the visitors to Yongin Severance Hospital who 
decided and agreed to participate voluntarily in this study, interviews are conducted in an independent space, an 
explanatory statement approved by the IRB is provided, and consent forms are obtained. 
After providing a sufficient explanation regarding participation in the clinical trial, the consent form must be 
completed in a non-oppressive environment, and when writing the consent form, participants must be explained 
that consent can be withdrawn at any time, so that they participate in the clinical trial. In addition, the intention to 
participate in the study is confirmed during the conduct of the study test, so that consent can be withdrawn at any 
time at the person's discretion. 
 
18. Protection measures when recruiting vulnerable subjects 
 Participants who are considered to have impaired cognitive function or lack sufficient understanding of the content 
of the study or consent form due to cognitive impairment will be excluded from the study. Vulnerable subjects such 

 
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as research institution employees, researchers, or students who are employed by the sponsor, will be excluded from 
recruitment for this study. 
 

 
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19. Information on the principal investigator and participating researchers, location of study conduct, 
and study period 
1) Principal investigator 
name 
Affiliated organization 
Major 
Job title 
phone 
Na Young 
Kim 
Yonsei University 
College of Medicine 
Yongin Severance 
Hospital 
rehabilitation 
medicine 
Clinical 
Assistant 
Professor 
031-5189-8163 
Kny8452 @yuhs.ac 
 
2) Test manager 
The test manager checks whether the test subject meets the selection criteria at the testing institution and 
manages the overall process of the experiment. 
name 
Affiliated organization 
Major 
Job title 
phone 
Na Young 
Kim 
Yonsei University 
College of Medicine 
Yongin Severance 
Hospital 
rehabilitation 
medicine 
Clinical 
Assistant 
Professor 
031-5189-8163 
Kny8452 @yuhs.ac 
 
3) Medical device manager 
name 
Affiliated organization 
Job title 
phone 
Seung Ick 
Choi 
Yonsei University  
College of Medicine 
Integrated 
course 
graduate 
student 
010-8821-5297 
rehab1@yuhs.ac 
 

 
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20. Location and duration of study 
1) Location of study 
Organization name 
location 
phonel 
Yonsei University  
College of Medicine 
Yongin Severance 
Hospital 
363 Dongbaekjukjeon-daero, 
Giheung-gu, Yongin-si, Gyeonggi-do 
031-5189-8891 
 
2) Period 
48 months after IRB approval (e.g. June 2021 – May 2025) 
 
21. Data safety monitoring plan 
The safety inspector (principal investigator) monitors the overall study progress at monthly intervals to ensure the 
completeness of the data, including the status of the study, whether the registration subjects are suitable for the 
selection criteria, the appropriateness of the consent acquisition procedure, whether violations/deviations from the 
study plan have occurred, and whether the subjects have had adverse reactions. 
 
22. Study plan (schedule table) 
 
 
Detailed development 
items 
Detailed schedule (months) 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
Study protocols and IRB 
approval 
█ 
 
 
 
 
 
 
 
 
 
 
 

 
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Subject Recruitment 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
 
Conduct of study 
procedures and follow-
up period 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
 
Detailed schedule (months) 
13 
14 
15 
16 
17 
18 
19 
20 
21 
22 
23 
24 
Subject Recruitment 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
Conduct of study 
procedures and follow-
up period 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
 
Detailed schedule (months) 
25 
26 
27 
28 
29 
30 
31 
32 
33 
34 
35 
36 
Subject Recruitment 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
Conduct of study 
procedures and follow-
up period 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
 
Detailed schedule (months) 
37 
38 
39 
40 
41 
42 
43 
44 
45 
46 
47 
48 
Subject Recruitment 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
 
Conduct of study 
procedures and follow-
up period 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
 
23. References 
Alexander NB. Differential diagnosis of gait disorders in older adults. Clin Geriatr Med 1996;12: 689–703. 
Tinetti ME. Clinical practice. Preventing falls in elderly persons. N Engl J Med 2003;348: 42–49. 

 
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Bennett DA, Beckett LA, Murray AM et al. Prevalence of parkinsonian signs and associated mortality in a community 
population of older people. N Engl J Med 1996;334: 71–76. 
SALZMAN, Brooke. Gait and balance disorders in older adults. American family physician, 2010, 82.1: 61-68. 
VERGHESE, Joe, et al. Epidemiology of gait disorders in community‐residing older adults. Journal of the American 
Geriatrics Society, 2006, 54.2: 255-261. 
Fortin C, Ehrmann Feldman D, Cheriet F, Labelle H. Clinical methods for quantifying body segment posture: a 
literature review. Disability and rehabilitation. 2011;33(5):367-383. 
Camplani M, Salgado L. Background foreground segmentation with RGB-D Kinect data: An efficient combination of 
classifiers. Journal of Visual Communication and Image Representation. 2014;25(1):122-136.  
Kim H, Lee S, Lee D, Choi S, Ju J, Myung H. Real-time human pose estimation and gesture recognition from depth 
images using superpixels and SVM classifier. Sensors. 2015;15(6):12410-12427. 
Oh J, Yang Y, Kim B, Kang J. Validity and Reliability of Korean Version of International Physical Activity 
Questionnaire(IPAQ) Short Form. J Korean Acad Fam Med 2007;28:532-541