Research on Evaluation of Home-based Rehabilitation Monitoring System With Wearable Devices and Self-Report Application
Phase: NA
Conditions: Gait Disorders, Neurologic
Sponsor: Yonsei University

 
Severance: smartinsole_20230824 
Cover page for ClinicalTrials.gov 
 
Name of the document: 
Study protocol and Statistical Analysis Plan 
 
Official Title of the Study: 
Development and Data Collection Study of a Home-Based 
Gait Rehabilitation Service Using an Insole-Type Gait 
Analyzer, Activity Tracker and Self-Report Application. 
 
NCT number 
NCT06410755 
 
Date of the document: 
January 25, 2026 
 
 
 
 

 
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Prospective Clinical Research Protocol 
 
1. Research Title, Phase, Protocol Identification Number, and Revision History 
- Research Title: Development and Data Collection Study of a Home-Based Gait Rehabilitation Service Using an Insole-
Type Gait Analyzer, Activity Tracker and Self-Report Application. 
 
2. Research Protocol Summary 
Research Objective 
To simultaneously utilize an activity tracker and an insole-type gait analyzer for 
patients with gait disorders, monitoring gait, activity levels, and physiological 
signals at home while providing integrated feedback. This aims to assess the 
system's usability and satisfaction, analyze changes in gait indicators and physical 
function before and after monitoring, and verify its efficacy. 
Research Design Overview 
Researcher-Initiated Exploratory Clinical Study 
6 weeks, randomized controlled trial 
Medical Devices  
for clinical trials 
Insole-type gait analyzer 
Target Sample Size and 
Calculation Basis 
80 patients with objective gait impairment but capable of independent walking 
This study explores whether data obtained from home use of an insole-type gait 
analyzer, activity tracker, and self-report application is clinically significant. The 
target subject number was set considering clinical conditions. 
Calculation Basis: The target subject number was set by considering clinical 
conditions, aiming to recruit 1 subject per week, 4 subjects per month. 
Selection and exclusion 
criteria 
1. Inclusion Criteria 
1) Adults aged 19 years or older 
2) Patients with a modified Rankin Scale (mRS) score of 2-3 who are ambulatory 
3) Individuals visiting Severance Hospital in Yongin who understand the study, 
provide informed consent, and complete the consent form 
2. Exclusion Criteria 
1) Individuals with contraindications to weight-bearing on the lower limbs, such 
as severe lower limb joint contractures, osteoporosis, or untreated fractures 
2) Progressive or unstable brain disease 
3) Individuals with clinically significant findings deemed medically inappropriate 
for this study by the principal investigator or responsible staff, beyond the above 
criteria 
 
Research Method 
After obtaining informed consent, a screening examination is conducted. The 
screening assesses whether the subject can independently walk at least 10 meters, 
regardless of assistive device use, following a review of baseline symptoms and 
signs. 
Subjects passing the screening test are randomly assigned to either the experimental 
group or the control group, and both groups undergo an initial evaluation. 
Subsequently, subjects receive comprehensive information regarding their physical 
condition, appropriate exercise intensity (heart rate), and walking status (based on 
normal walking criteria), followed by instruction on the home exercise program. 
The researcher provides the experimental group with both an activity tracker and 

 
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an insole-type gait analyzer and instructs them on usage. Participants are 
instructed to wear the devices as much and as long as possible to record usage 
time, exercise volume, and gait patterns. They are also instructed to respond daily 
via an application to five surveys: sleep, mood, exercise time, pain, and appetite, 
completed after waking and before bedtime. Based on the collected measurement 
data (heart rate, gait data, etc.), the researcher provides integrated feedback via 
phone call once a week. In contrast, the control group receives neither wearable 
devices nor data-based feedback. 
After 6 weeks, the home exercise program ends, and a final evaluation identical 
to the initial assessment is conducted. The experimental group also completes 
satisfaction evaluations for the activity tracker, insole-type gait analyzer, and 
application. During the study period, any device malfunctions are addressed and 
recorded. Device usage rates and satisfaction levels in the experimental group are 
analyzed, and pre- and post-program evaluation metrics for both groups are 
compared and analyzed. 
Evaluation Variables 
1) Primary Evaluation Variables 
- 6-Minute Walk Test results 
2) Secondary Evaluation Variables 
- 10m walk test 
- Body composition analysis results 
- Spatiotemporal parameters of gait 
- Korean version of the Mini-Mental State Examination (K-MMSE) 
- Geriatric Depression Scale (GDS) 
- Korean Sarcopenia Screening Questionnaire 
- Korean version of the International Physical Activity Questionnaire (K-IPAQ) 
- Handgrip strength test results 
- Clinical Vulnerability Scale 
- Health-Related Quality of Life Assessment (EQ-5D) 
- Mini Nutritional Assessment (MNA) 
- Activities of Daily Living and Instrumental Activities of Daily Living Assessment 
(ADL & I-ADL assessment) 
- Simple Physical Performance Battery (SPPB) 
- Timed Up and Go Test (TUGT) 
- Berg Balance Scale (BBS) 
- Cybex Isokinetic Exercise Test 
- Correlation coefficient between IPAQ responses and average exercise values 
recorded on smartphones 
- IPAQ response rate variation 
- Application survey response rate and daily data recording count on wearable 
devices 
- (For the experimental group only) Satisfaction survey regarding the use of the 
K-QUEST-based 12-item 5-point scale insole-type gait analyzer 
Data Analysis and Statistical 
Methods 
1) Primary and Secondary Evaluation Variables: Descriptive statistics will present 
differences before and after the home exercise program. Changes in performance 
will be compared using paired t-tests. Differences in survey response rates will be 
presented using descriptive statistics, and changes in response rates will be compared 
using correlation analysis. 

 
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2) Satisfaction Evaluation: Satisfaction with the home exercise program utilizing the 
insole-type gait analyzer, activity tracker, and application will be analyzed and 
presented using descriptive statistics. 
 
3. Research Background and Theoretical Basis 
Importance of Gait and Lifestyle Habit Management Gait is a movement performed daily through the complex 
coordination of the central and peripheral nervous systems and the musculoskeletal system. Damage to the gait system 
due to degenerative brain diseases, peripheral nerve damage, osteoarthritis, etc., can lead to changes in gait patterns. 
This directly correlates with reduced cardiopulmonary function and diminished ability to perform activities of daily 
living. Furthermore, maintaining healthy lifestyle habits in modern society plays a crucial role in preventing chronic 
diseases and improving quality of life. Since various lifestyle factors—including exercise, diet, and sleep—interact, 
systematic management is essential. Particularly for the elderly or those with degenerative diseases, monitoring 
appropriate exercise intensity and gait status through objective and safe methods is vital. 
Advancements in Remote Monitoring Using Wearable Technology While wearable sensors once only enabled simple 
heart rate measurement, recent miniaturization of sensors and advancements in wireless technology have made 
kinematic analysis possible. This has led to increasing attempts to precisely analyze gait patterns and posture remotely. 
Activity trackers utilize accelerometers and optical sensors to track physiological information such as activity levels, 
heart rate, and sleep, and are useful for monitoring exercise intensity (e.g., predicting VO2max).  
Insoles-type gait analyzers are devices worn inside shoes to measure spatiotemporal parameters of walking. They offer 
the advantages of being easy to use and inexpensive, while showing high correlation with standardized 3D gait analysis 
results. Additionally, smartphone applications, when linked with these devices, serve as an efficient medium for 
collecting patient-reported outcome (PRO) data such as pain, mood, and appetite without requiring hospital visits. 
Limitations of Previous Research and the Need for This Study To promote the health of patients with gait disorders, 
interventions must simultaneously focus not only on increasing the quantity of walking but also on improving the quality 
of gait to approximate normal walking and maintaining appropriate exercise inten sity. However, existing studies have 
generally been limited to fragmented approaches, such as using only activity trackers to monitor activity levels or only 
gait analyzers to observe gait patterns. Furthermore, most studies used prototype devices, limiting their practical clinical 
application, and often failed to provide healthcare professionals with specific feedback based on the collected data. 
Research cases that comprehensively monitor and ma nage lifestyle habits, exercise intensity, and gait patterns in 
outdoor or home environments remain scarce. 
Research Purpose Therefore, this study utilizes a framework combining a commercially available activity tracker, an 
insole-type gait analyzer (for gait patterns), and a self-reporting application. Through this, we aim to explore the 
feasibility and utility of a home-based rehabilitation service that comprehensively monitors patients' lifestyle factors 
and gait status in a home environment and provides personalized feedback based on this data. 
 
4. Research Objectives 
Monitoring of gait status, exercise intensity, pain, sleep, appetite, and other lifestyle factors in a home environment for 
patients with gait disorders using an insole-type gait analyzer, an activity tracker, and a linked self-reporting mobile 
application, and providing feedback on these factors. This aims to analyze the usability and satisfaction of each device 
and compare changes in gait indicators before and after monitoring to confirm the utility of the home-based monitoring 
system.  

 
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5. Risk/Benefit Analysis 
This study will administer the 6-minute walk test, the Timed Up and Go test (TUG), and the 10m walk test to assess 
walking ability. These tests are widely used standardized assessment tools in clinical settings, and the medical risk 
associated with the tests themselves is very low. However, to minimize the risk of falls during testing, participants will 
undergo sufficient practice before the tests. The examiner will supervise throughout the entire process, and testing will 
be conducted in an environment equipped with safety bars. 
Additionally, the activity tracker used in this study collects physiological data such as heart rate using non - invasive 
photoplethysmography (PPG) technology. This technology illuminates the skin with light-emitting diodes and measures 
reflected and transmitted light. While rare cases of skin irritation or infection have been reported during prolonged wear, 
the incidence rate is known to be very low. The smart insole is manufactured to the same specifications as commercially 
available insoles and replaces the user's existing insole. As a device used in everyday wear environments, it contains no 
invasive elements, and no significant adverse reactions have been reported to date. 
Participants in this study can receive objective information about their physical function, including grip strength, 
muscle mass, walking and balance abilities, physical activity levels, and heart rate. They can also understand their 
functional level through feedback comparing measured walking and heart rate metrics against normal standards, and 
receive education on home exercise programs based on age-appropriate exercise intensity guidelines.  
Furthermore, the gait data, heart rate information, and lifestyle survey results collected through this study can validate 
the utility of real-time monitoring for home-based exercise programs and be utilized in future research related to disease 
treatment and prognosis prediction. This is expected to contribute to the expansion of medical knowledge and the 
improvement of clinical care quality. Considering these points collectively, the benefits obtainable through this research 
are judged to outweigh the potential risks that may arise from it 
 
6. Target Sample Size and Calculation Basis 
This study will be conducted on all patients visiting Yongin Severance Hospital who consent to participate and meet the 
selection criteria. The target is to recruit one subject per week, four subjects per month, from among Yongin Severance 
Hospital visitors. Considering dropout rates and clinical conditions, the target number of subjects was determined to be 
80. 
 
7. Subject Selection/Exclusion Criteria 
(1) Inclusion Criteria  
1) Adults aged 19 years or older 
2) Patients with a Modified Rankin Scale (mRS) score of 2-3 who are ambulatory 
3) Individuals visiting Yongin Severance Hospital who understand the study, provide informed consent, and complete  
a consent form 
 
 
 

 
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(2) Exclusion Criteria 
1) Individuals with contraindications to lower limb weight-bearing, such as severe lower limb joint contractures,  
osteoporosis, or untreated fractures 
2) Progressive or unstable brain disease 
3) Individuals with clinically significant findings deemed medically inappropriate for this trial by the principal  
investigator or responsible personnel, in addition to the above 
 
8. Information and Management of Investigational Medicinal Products/Medical Devices 
This study does not conduct a clinical trial; however, the information and management methods for the medical device 
used in this study are as follows. 
(1) Insole-type gait analyzer 
1) Product Name: Gait Analyzer 
2) Classification Number: A30110.01 
3) Packaging Unit: 1 set 
4) Medical Device Class: Class 1 
5) Model Name: mobiCARE-MC100 
6) Manufacturer: Gilon Co., Ltd. 
7) License Number: No. 20-1753  
8) Principle of Operation and Appearance 
 
 
9) Usage Method and Precautions - Refer to the attached document  

 
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(2) Fitbit inspire 2  
1) Item Name: Activity Tracker 
2) Sensors and Components 
- 3-axis accelerometer, optical heart rate monitor, infrared sensor for blood oxygen (SpO2) measurement, 
vibration motor, ambient light sensor 
3) Operating Environment: Temperature 0 – 40 °C, Maximum Operating Altitude: 8,534m 
4) Battery Certification and Number 
- Certification Authority: National Radio Research Agency 
- Certification number: R-C-XIRA-FB424 
- KC Certification Type: Certificate of Conformity for Broadcasting and Telecommunications Equipment 
5) Certification Authority and Number  
- Certification Body: Korea Testing Laboratory 
- Certification Number: YU10211-22004 
- KC Certification Type: Safety Confirmation Report Certificate 
6) Manufacturer: Fitbit  
 
 
 
 
 
 

 
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(3) Big 4+ Homespital version 
 
1) Item Name: Smartphone Application 
2) Manufacturer: DigitalMedic Co., Ltd. 
Function: Health monitoring and clinical assessment tool-based lifestyle factor recording, including location information 
collection, distance traveled measurement, step count, fitness information collection, sleep tracking, and smartphone 
usage 
 
(4) Device Management 
The medical devices used in this study will be provided to participants. Participants will be instructed on precautions  
for device use and storage methods. Prior to distribution, equipment will be managed at a designated location  
(Rehabilitation Functional Testing Lab, 2nd Floor, Yongin Severance Hospital). (Refer to the attached document) 
 
 
 
 
 
 
 
 

 
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9. Study Design (Trial Group·Control Group, Allocation, Blinding, and Flowchart, etc.)  
(1) Research Design Overview  
This is an investigator-initiated exploratory clinical study designed with random assignment and conducted over 6 weeks.  
(2) Experimental Group  
The experimental group consists of a single group using all three devices: the insole-type gait analyzer, activity tracker, 
and self-reporting application. Participants are instructed to wear the insole-type gait analyzer and activity tracker as 
much and as long as possible during outdoor activities. They are also instructed to self-report daily life factors such as 
sleep quality before bedtime, exercise volume, mood, pain, and appetite via the self-reporting application linked to the 
activity tracker. 
At the study start, participants receive the insole-type gait analyzer and activity tracker from the examiner and receive 
training on the home-based self-exercise program and how to use each device and the self-reporting application. The 
researcher provides weekly feedback to participants via telephone, synthesizing data collected through the insole-type 
gait analyzer, activity tracker, and self-reporting application. 
At the midpoint of the study (Week 3), participants visit the hospital for a check-up on the usage status of the insole-
type gait analyzer, activity tracker, and self-reporting application, and complete the same physical activity questionnaire 
administered during the initial assessment. After the 6-week intervention concludes, a final assessment identical to the 
initial evaluation is conducted. Participants return only the activity tracker and complete an evaluation of usage and 
satisfaction regarding the insole-type gait analyzer, activity tracker, and self-report application. 
(3) Control Group 
The control group receives the same exercise program education as the experimental group but is not provided with the 
insole-type gait analyzer and does not receive exercise feedback. 
(4) Randomized Assignment 
This clinical trial will be conducted by the investigator assigning a registration number to each subject and performing 
randomization using an Excel-based randomization table. 
 
 
 
 
 
 
 
 
 
 
 
 

 
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10. Research Methods 
(1) Screening Method 
The examiner will conduct a medical history interview to assess the subject's baseline symptoms and signs, check  
vital signs to confirm medical stability, and determine whether the subject can walk independently for at least 10  
meters with or without assistive devices. 
(2) Pre- and Post-Intervention Program Evaluation Indicators 
1) Primary Evaluation Indicators 
➀ 6-Minute Walk Test 
The subject performs the 6-minute walk test10 while wearing an insole-type gait analyzer, simulating daily  
walking as closely as possible. The examiner provides feedback on gait by comparing the average parameter data 
extracted from the insole-type gait analyzer to normal gait standards. This evaluation assesses walking endurance and 
is conducted as follows. 
a) Set up colored cones marking a 30m distance on the floor and prepare a stopwatch. 
b) Instruct the subject to walk back and forth as many times as possible along the 30m straight distance for 6 minutes. 
c) Inform the subject that they may rest during the test and may stop, using only permitted phrases ('You're doing well', 
'Keep going'). 
d) The examiner records the total distance traveled, the pattern of abnormal gait, and the time of occurrence 
 
2) Secondary Evaluation Indicators 
① Body Composition Analysis 
This test is performed to assess the subject's limb muscle mass. The testing method is as follows.  
a) Conduct body composition analysis based on bioelectrical impedance analysis 11 
b) To ensure accurate measurement, the subject is instructed to empty their bladder before the test and to avoid  
caffeine-containing beverages, food intake, alcohol consumption, and vigorous exercise one hour prior to the test. 
c) To correct for differences in muscle mass due to height, appendicular skeletal mass (ASM) is calculated and used  
by dividing it by the square of height. 

 
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② Spatiotemporal Parameters of Gait 
Spatio-temporal gait parameter data collected while the subject wears an insole-type gait analyzer at home and  
performs activities, recording total steps, steps per minute, walking speed, walking distance, stride length , and swing 
phase ratio. 
③ Korea-Mini Mental State Examination (K-MMSE) 
This test assesses the overall degree of cognitive impairment, considering the subject's educational level. 12 It  
evaluates orientation to time and place, attention and calculation ability, memory, language, and spatial -temporal 
construction ability. The examiner asks questions corresponding to the items on the test sheet and records scores for the 
responses. 
 
 
 
 
 

 
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④ Korean version of short form of Geriatric Depression Scale 
This is a test used to assess the level of depression in older adults13 and able to assess quickly the level of depression 
in the elderly and identify risk. The examiner asks the subject questions according to the questionnaire below, checks 
items according to the answers, and scores them according to the evaluation method.  
This consists of 15 items and is the most used version due to its brevity and ease of use. It can typically be completed 
in 5 to 7 minutes. Each item on the GDS is scored 0 or 1, depending on whether the symptom of depression is absent or 
present according to the patient's response. The total score is calculated by summing up the scores for each item. 
Generally, a score of 0 to 5 is considered normal, depending on the setting and clinical judgment. Scores of 5 or more 
suggest depression, with scores of 10 or higher almost always indicative of depression. 
 

 
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⑤ Korean version of Sarcopenia Screening Questionnaire 
Questionnaire that evaluates the decrease in muscle strength and functional performance along with a decrease in 
muscle mass14 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. 
 
⑥ Functional Ambulation Category 
Assessment of the subject's walking function.15 The examiner observes the subject's gait and records a score based on 
the criteria in the assessment sheet below. 
 

 
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⑦ Korean version of the International Physical Activity Questionnaire (K-IPAQ)  
Tests that assess various aspects of an individual's daily physical activity 16 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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⑧ Grip Strength Test 
A test that evaluates the subject's grip strength, and the evaluation method is as follows. 
a) The subject sits in the correct posture and bends the elbows to 90 degrees. 
b) Place the handle of the measuring device between the first and second joints of each finger and hold it tightly 
according to the examiner's instructions. 
c) Measure the left and right three times each and record the maximum value. 
.
 
⑨ Clinical Frailty Scale 
Test to assess the health status and frailty of elderly18 and assesses the health and vulnerability of the elderly after the 
program ends. The scale ranges from 1 to 9, with each level described through specific criteria that reflect the degree 
of fitness or frailty, a higher score means poorer health. 
 
 
 
score 
name 
detailed description 
1 
very healthy 
Exercising regularly and living an active life 
2 
healthy 
Exercising regularly and living an active life, but have had an 
illness or accident in the past 
3 
Have a well-
managed disease 
Although there are some limitations due to illness or 
accidents, the ability to live independently 
4 
slightly vulnerable There are some limitations due to illness or accidents, and it is 
difficult to conduct daily life independently. 
5 
vulnerable 
There are many limitations due to illness or accidents, and it 
is difficult to conduct daily life independently. 
6 
Moderately 
vulnerable 
Have many limitations due to illness or accident and are 
unable to perform daily activities without assistance 
7 
Severely 
Vulnerable 
Completely dependent, unable to get out of bed without 
assistance 
8 
Very Severely 
Vulnerable 
Completely dependent, unable to move even in bed 
9 
terminally ill 
Patients expected to die within 6 months 

 
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⑩ European Quality of Life-5 Dimensions 
It consists of items evaluating exercise ability, self-management, daily activities (work, study, housework, family or 
leisure activities), pain/discomfort, and anxiety/depression, 19 and examiner evaluates according to the form below. 
Participants will be asked to answer each question with 3 items, and a higher score means more health problems, 
minimum score is 5 and maximum score is 15. 
Health-related quality of life assessment 
item 
step 
Mark 
O 
athletic 
ability 
I have no trouble walking 
 
I have some trouble walking. 
 
I can't walk. 
 
selfcare 
I have no trouble taking a bath or getting 
dressed. 
 
I have some trouble bathing or dressing myself.  
I cannot bathe or dress myself. 
 
activities of 
daily living 
I have no trouble doing my daily activities. 
 
I have some difficulty doing daily activities on 
my own. 
 
I cannot do daily activities on my own. 
 
pain and 
discomfort 
I have no pain or discomfort. 
 
I have some pain or discomfort. 
 
I have very severe pain or discomfort. 
 
anxiety and 
depression 
I am not anxious or depressed. 
 
I feel somewhat anxious or depressed. 
 
I am very anxious or depressed. 
 
 
 
 
 
 

 
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⑪ Mini-Nutritional Assessment 
An assessment of nutritional status and risk of undernutrition or malnutrition using questionnaire to assess the 
nutritional status of a subject,20 and the examiner records a score based on the criteria in the questionnaire below. 
 
 

 
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⑫ Assessment of activities of daily living and instrumental activities of daily living (ADL & I-ADL assessment) 
This assessment uses a questionnaire that assesses the nutritional status of subjects to determine their nutritional status 
and whether they are undernourished or at risk of being undernourished, and the examiner records a score based on the 
criteria in the questionnaire below. 
 
 
 

 
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⑬ Short Physical Performance Battery (SPPB) 
This is a test that evaluates three areas to assess a subject's lower extremity physical functioning, 23 and it measures and 
records scores in three areas: balance, getting up from a chair, and walking speed.  
a) Balance test: Line up feet in parallel and hold for 10 seconds. If possible, perform this test in a semi-upright position, 
then straighten feet and repeat 3 times. 
b) Chair stand-up test: Perform the stand-up test 5 times from a chair. The examiner measures the time and records the 
score according to the criteria below. 
c) Walking speed test: After having the subject walk 3m, the examiner measures the time and scores according to the 
criteria below. 
 
 

 
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⑭ Timed up and go test (TUG) 
The above test assesses walking speed along with balance ability during walking,24 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. 
 
⑮ 10-Meter Walk Test  
The 10-Meter Walk Test16 is used to assess gait speed in patients undergoing rehabilitation for neurological and 
Severance: H10_250409 musculoskeletal disorders. Participants wear an insole-type gait analyzer and walk a 10-meter 
straight path at a consistent pace while the time taken is measured to evaluate gait ability.  
a) A total straight path of 14 meters is prepared, with the first and last 2 meters serving as non-measurement zones.  
b) b) Participants are informed that their walking speed will be measured over the 10-meter section and are 
instructed to walk at a comfortable pace. 
 
 
 

 
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⑯ Berg Balance Scale 
The above test assesses static and dynamic balance,25 in which the examiner instructs the subject to perform the 14 
movements below and then scores them against a set of criteria. 
 

 
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⑰ Cybex isokinetic strength evaluation 
A test to measure lower extremity strength and power using the isokinetic exercise equipment CYBEX, 26 and 5 
repetitions of 60/60 degrees per second and 15 repetitions of 150/150 degrees per second are performed to measure 
Peak Torque (Nm), Total Work (J), Average power per repetition (W), and Fatigue Index (%) of the lower extremity 
muscles. 
 
 
 
 
 
 
 
 
 
 

 
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⑱ Application Survey Response Rate 
Based on the application usage instructions provided by the examiner, the subject completes the following 5 surveys 
before bedtime. The subject's weekly response rate is calculated based on their survey records: the number of responses 
out of 5 surveys completed and the number of days out of 7 days responses were submitted.  
𝑛𝑢𝑚𝑏𝑒𝑟 𝑜𝑓 𝑖𝑛𝑑𝑖𝑣𝑖𝑑𝑢𝑎𝑙 𝑠𝑢𝑟𝑣𝑒𝑦 𝑟𝑒𝑠𝑝𝑜𝑛𝑠𝑒𝑠
5
 ×  𝑛𝑢𝑚𝑏𝑒𝑟 𝑜𝑓 𝑤𝑒𝑒𝑘𝑙𝑦 𝑟𝑒𝑠𝑝𝑜𝑛𝑠𝑒𝑠
7
  × 100
=  𝑆𝑢𝑟𝑣𝑒𝑦 𝑟𝑒𝑠𝑝𝑜𝑛𝑠𝑒 𝑟𝑎𝑡𝑒%) 
1- Mood Survey 
 
As shown in the figure above, the subject starts the survey using the application installed on their smartphone  
and records their mood state. The scale is a 1-7 point Likert scale; the subject checks the corresponding mood  
state, presses the next button, and moves to the next survey. 
 
2- Appetite & Sleep Survey 
 
` 
As shown in the figure above, participants record their appetite throughout the day. The scale is a 1-7 point Likert scale. 
They check the corresponding appetite level, press the next button, and proceed to the next test. And the second figure 
above, record satisfaction with the previous night's sleep and sleep duration. The sleep satisfaction scale is a 1–7-point 
Likert scale. Check the corresponding sleep level, press the Next button, record the sleep duration, and proceed to the 
next test. 

 
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3- Physical Activity Survey 
The subject completes the survey based on the International Physical Activity Questionnaire (IPAQ) 20,21 regarding 
walking activity, moderate-intensity exercise, and vigorous-intensity exercise as follows. 
◼ Walking Activity Survey 
 
As shown in the figure above, check whether walking occurred. If walking occurred, record the walking time and 
proceed to the moderate-intensity exercise questionnaire. If no walking occurred, proceed directly to the moderate-
intensity exercise questionnaire. 
 
◼ Moderate-Intensity Exercise Survey 
 
As shown in the figure above, check whether moderate-intensity exercise was performed. If performed, record the 
duration of moderate-intensity exercise and proceed to the high-intensity exercise survey. If not performed, proceed 
directly to the high-intensity exercise survey. 

 
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◼ Vigorous-Intensity Exercise Survey 
 
As shown in the figure above, check whether vigorous intensity exercise was performed. If performed, record the 
vigorous intensity exercise time and proceed to the exercise intensity survey. If not performed, proceed directly to the 
exercise intensity survey 
◼ Subjective Exercise Intensity Survey 
 
As shown in the figure above, record the intensity of today's exercise. The exercise intensity scale is a 0-10 Likert scale. 
Check the corresponding intensity level, press the Next button, and proceed to the pain survey. 

 
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4- Pain Survey 
The subject completes a survey related to walking activity, moderate-intensity exercise, and high-intensity exercise 
based on the Visual Analog Scale (VAS)22 as follows. 
 
 
As shown in the figure above, check whether pain is present. If pain is present, select each item (neck, shoulder, wrist, 
lower back , hip joint, knee, ankle) and score it on a 0-10 Likert scale. Then end the test. If no pain is present , end the 
test immediately. 
 
⑲ Correlation coefficient between the Korean Short-Form International Physical Activity Questionnaire (K-IPAQ) 
and the average value of exercise recorded in the application 
K-IPAQ is a test that evaluates an individual's daily physical activity from various aspects and can provide 
information on activity levels. The examiner asks the subject questions based on the questionnaire below, records 
relevant information, calculates total activity time and intensity, and classifies it as 'light', 'moderate', or 'vigorous'.  
The examiner administers the Korean version of the International Physical Activity Questionnaire (K -IPAQ) to the 
subject at three points: baseline, 3 weeks, and 6 weeks. Correlation analysis is then performed using the questionnaire 
results and the exercise data recorded by the subject via the application to extract the correlation coefficient value. 
 
⑳ Changes in Responses to the Korean Short -Form International Physical Activity Questionnaire (K-IPAQ) 
The examiner calculates the change rate by using a paired sample t -test to compare the difference in response rates, 
utilizing the results of the Korean version of the Short Form International Physical Activity Questionnaire administered 
at baseline and at 6 weeks. 
 
 
 
 
 
 
 
 
 

 
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(3) Home Exercise Program Education 
Participants' gait parameter data is extracted through the primary assessment variable, the 6-Minute Walk Test. Feedback 
is provided based on the following normal gait criteria. Following the pre-intervention assessment, exercise education 
is provided individually according to the patient's age, gender, underlying conditions, and muscle strength and endurance.  
1) Providing Information on the Subject's Gait Status and Normal Gait Criteria  
The examiner provides feedback on gait to the experimental group participants by comparing the average values of the 
gait parameters extracted from the above gait assessment against the normal gait criteria. The extracted gait parameters 
and normal gait criteria are as follows. The control group does not undergo this process. 
➀ Step count: The number of steps measured while walking after linking the insole-type gait analyzer with a smartphone 
application 
➁ Cadence: Number of steps measured per minute, unit: Steps/min (spm). Normal cadence is 70 steps/min for those 
under 65 years old and 60 steps/min or higher for those aged 65 and over.27 
➂ Gait Speed: The speed of walking, measured in km/h. Normal values are 2.0 km/h for t hose under 65 and 1.5 km/h 
or higher for those aged 65 and over.28 
➃ Distance: The total distance measured during walking, measured in meters. 
➄ Stride Length: Represents the distance from one heel to the same heel. The unit is meters (m). To correct for 
differences caused by height, stride length is divided by height. Normal values are 0.5 m/height for those under 65 and 
0.4 m/height or higher for those aged 65 and over.28 
➅ Swing ratio: The percentage of the swing phase within one gait cycle, measured in %. For those under 65, 30% is 
normal, and for those 65 and older, 28% or higher is normal. 29 
2) Home Exercise Program Education 
The researcher instructs all subjects on the following program. 
➀ Exercise Program Structure 
a) Warm-up: 5-10 minutes of low-intensity (<40% VO2 max) or moderate-intensity (40-60% VO2 max) activity 
b) Stretching: Perform for 10 minutes after the warm-up 
c) Main Exercise: Tailored to the patient's fitness level, consisting of 20-30 minutes of aerobic exercise (using a 
stationary bike or treadmill, or walking), strength training at 60-80% of the patient's maximum strength (1 set of 10-15 
repetitions per muscle group, performed 2-3 times), and flexibility training (upper and lower body stretching) d) Cool-
down: Perform 5-10 minutes of low-intensity (<40% VO2 max) or moderate-intensity (40-60% VO2 max) 
cardiovascular and muscular endurance exercise 
The intensity of aerobic exercise is set using the Karvonen target heart rate formula.30 To calculate the target heart rate, 
use resting heart rate, maximum heart rate, and exercise intensity. Resting heart rate is measured after lying down and 
resting for 3-5 minutes. The maximum heart rate is calculated using (220 − age) . Exercise intensity is expressed as a 
percentage of the maximum heart rate, representing the ratio of the heart rate during exercise to the maximum heart rate. 
The target heart rate is set according to the following formula. 
𝑇𝑎𝑟𝑔𝑒𝑡 𝐻𝑒𝑎𝑟𝑡 𝑅𝑎𝑡𝑒 = (HRmax – HRrest) × Exercise Intensity + HR rest 

 
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Aerobic exercise is performed at 60% intensity for 20-60 minutes, 3-5 times per week. Low-intensity exercise is 
performed for patients unable to tolerate high-intensity exercise. 
(4) Subject Monitoring Methods 
1) Home Exercise Monitoring 
The researcher provides weekly feedback via phone to the experimental group using the insole-type gait analyzer, 
tailored to the collected exercise volume and gait level of the subject. The stability of data collection is verified, and any 
abnormalities are addressed and recorded via phone or in-person visit. 
Gait data collection via the insole-type gait analyzer is conducted by connecting the analyzer to the subject's smartphone, 
transmitting measured data to a web server. The medical device company provides the researcher with data sorted by 
the analyzer's product serial number once per week. The researcher monitors the subject's activity level, identifies 
differences between the subject's gait metrics and normal standards, and provides weekly feedback via phone. The 
control group does not undergo these procedures. 
 
 
 

 
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(5) Satisfaction assessment 
 Experimental group participants return the insole-type gait analyzer and activity tracker to the examiner and complete 
a 12-item, 5-point scale satisfaction survey for the insole-type gait analyzer, activity tracker, and application. This survey 
is based on the Korean version of the assistive device satisfaction test (K-QUEST 2.0)32. This questionnaire consists of 
12 items to evaluate satisfaction, and satisfaction with assistive devices and related services is indicated on a scale of 1 
to 5 below. If any items other than “very satisfied” are filled out, the subject is instructed to write a reason. The control 
group does not do the above. 
1: Very unsatisfied 2: Not satisfied 3: Average 4: Satisfied 5: Very satisfied 
 
1 
2 
3 
4 
5 
Are you satisfied with the specifications (size, height, length, width) of the smart insole? 
reason: 
_________________________________________________________________________ 
 
 
 
 
 
How does the smart insole weigh? 
reason: 
_________________________________________________________________________ 
 
 
 
 
 
Is it convenient to adjust (fix and lock) the parts (accessories) of the smart insole? 
reason: 
_________________________________________________________________________ 
 
 
 
 
 
Do you think smart insoles are safe and sturdy? 
reason: 
_________________________________________________________________________ 
 
 
 
 
 
Are you satisfied with the durability (long-term usability) of the smart insole? 
reason: 
_________________________________________________________________________ 
 
 
 
 
 
Was it convenient to use the smart insole? 
reason: 
_________________________________________________________________________ 
 
 
 
 
 
Do you think smart insoles are comfortable to wear? 
reason: 
_________________________________________________________________________ 
 
 
 
 
 
Are you satisfied with the effectiveness of the smart insole (effectiveness suited to the purpose 
of use)? 
reason: 
_________________________________________________________________________ 
 
 
 
 
 
Are you satisfied with Smart Insole’s service and delivery program (delivery process and 
time required)? 
reason: 
_________________________________________________________________________ 
 
 
 
 
 
Are you satisfied with the repair and maintenance services for smart insoles? 
reason: 
_________________________________________________________________________ 
 
 
 
 
 
Are you satisfied with the professional service (information and precautions) you received 
while using the smart insole? 
reason: 
_________________________________________________________________________ 
 
 
 
 
 

 
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Are you satisfied with Smart Insole’s after-sales service (continuous management service)? 
reason: 
_________________________________________________________________________ 
 
 
 
 
 
 
- Among the 12 items regarding satisfaction, please mark the 3 items you consider most important. 
 
O sign 
1. Specifications 
 
2. Weight 
 
3. Convenience 
 
4. Safety 
 
5. Durability 
 
6. Usability 
 
7. Comfort 
 
8. Effect 
 
9. Service delivery 
 
10. Repair and maintenance services 
 
11. Professional services 
 
12. After-sales service 
 
 
1: Very unsatisfied 2: Not satisfied 3: Average 4: Satisfied 5: Very satisfied 
 
1 
2 
3 
4 
5 
Are you satisfied with the specifications (size, height, length, width) of the activity 
tracker? 
reason: 
_________________________________________________________________________ 
 
 
 
 
 
How does the activity tracker weigh? 
reason: 
_________________________________________________________________________ 
 
 
 
 
 
Is it convenient to adjust (fix and lock) the parts (accessories) of the activity tracker? 
reason: 
_________________________________________________________________________ 
 
 
 
 
 
Do you think activity tracker is safe and sturdy? 
reason: 
_________________________________________________________________________ 
 
 
 
 
 
Are you satisfied with the durability (long-term usability) of the activity tracker? 
reason: 
_________________________________________________________________________ 
 
 
 
 
 
Was it convenient to use the activity tracker? 
reason: 
_________________________________________________________________________ 
 
 
 
 
 
Do you think activity trackers are comfortable to wear? 
reason: 
_________________________________________________________________________ 
 
 
 
 
 

 
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Are you satisfied with the effectiveness of the activity tracker (effectiveness suited to the 
purpose of use)? 
reason: 
_________________________________________________________________________ 
 
 
 
 
 
Are you satisfied with Activity tracker’s service and delivery program (delivery process 
and time required)? 
reason: 
_________________________________________________________________________ 
 
 
 
 
 
Are you satisfied with the repair and maintenance services for activity tracker? 
reason: 
_________________________________________________________________________ 
 
 
 
 
 
Are you satisfied with the professional service (information and precautions) you received 
while using the activity tracker? 
reason: 
_________________________________________________________________________ 
 
 
 
 
 
Are you satisfied with Activity tracker’s after-sales service (continuous management 
service)? 
reason: 
_________________________________________________________________________ 
 
 
 
 
 
 
- Among the 12 items regarding satisfaction, please mark the 3 items you consider most important. 
 
O sign 
1. Specifications 
 
2. Weight 
 
3. Convenience 
 
4. Safety 
 
5. Durability 
 
6. Usability 
 
7. Comfort 
 
8. Effect 
 
9. Service delivery 
 
10. Repair and maintenance services 
 
11. Professional services 
 
12. After-sales service 
 
 
 
 
 
 
 
 

 
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11. Study procedures and evaluation 
Phase 
Screening / 
Intervention 
Intervention 
Intervention/ 
Assessment 
Whether or 
not to 
conduct a 
control 
group 
week 
1 
2 
3 
4 
5 
6 
written consent 
O 
 
 
 
 
 
O 
Selection/exclusion 
criteria 
O 
 
 
 
 
 
O 
Demographic 
information and 
antecedent history 
O 
 
 
 
 
 
O 
Primary evaluation 
indicator 
evaluation 
O 
 
 
 
 
O 
O 
Secondary 
evaluation 
indicator 
evaluation 
O 
 
 
 
 
O 
O 
Home-based 
exercise program 
O 
O 
O 
O 
O 
O 
O 
Phone monitoring 
and feedback 
O 
O 
O 
O 
O 
O 
X 
Satisfaction 
evaluation 
 
 
 
 
 
O 
X 
 
12. Criteria for stopping and dropping out of the study 
(1) Termination and early suspension 
1) 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 
1) 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. 
 

 
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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 randomized controlled study with little room for invasive intervention such as the need for separate procedures, 
the risk level of the study is low, so monitoring will be conducted once a week 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 
(1) Primary and secondary evaluation variables: The differences before and after the home-based exercise program are 
analyzed using descriptive statistics to present the mean, standard deviation, median, minimum and maximum values, 
and the change in performance by group is compared through a paired-sample T test. 
(2) Satisfaction evaluation: Satisfaction with the home-based exercise program using smart insoles is analyzed using 
descriptive statistics and the mean, standard deviation, median, minimum and maximum values are presented. 
 
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 must be kept secret from anyone other than the researchers involved in the 
study and it is used for study purposes only. Sensitive personal information that can identify individuals will not be 
shared with organizations other than the hospital and will go through an anonymization process (deidentification). 
Anonymization is achieved by using the unique number of the insole-type gait analyzer issued to the subject, and data 
collected through the application will be stored in accordance with the medical device company's security policy and 
will be discarded after the end of the study, and will be de-identified before being forwarded to the medical device 
company. De-anonymization is limited to cases where it is necessary in relation to the individual's treatment. Only the 
final results of the analysis are disclosed to medical device companies and ownership of the data lies with the hospital.  
 

 
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(2) Confidentiality of study materials 
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 
 This study does not recruit vulnerable subjects.  
 
 

 
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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 
Assistant 
Professor 
031-5189-8163 
Kny8452 @yuhs.ac 
Seung Ick 
Choi 
Yonsei University  
College of Medicine 
Department 
of Integrative 
Medicine 
Integrated 
course graduate 
student 
010-8821-5297 
rehab1@yuhs.ac 
So Jeong 
Lim 
Yonsei University 
Industry-Academic 
Cooperation Foundation 
occupational 
therapy 
researcher 
010-2971-3773 
rehab2@yuhs.ac 
Hwi Woo 
Yang 
Yonsei University 
Industry-Academic 
Cooperation Foundation 
occupational 
therapy 
researcher 
010-7360-4439 
rehab5@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 
36 months after IRB approval (e.g. October 2023 - October 2026) 
 
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 
1 1 1 2 
Study protocols and IRB 
approval 
█ 
 
 
 
 
 
 
 
 
 
 
 
Subject Recruitment 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
Conduct of study 
procedures and follow-up 
period 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
Detailed development 
items 
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 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 

 
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