Development and Feasibility Study of the Home-based Gait Rehabilitation Service by Using the Insole-type Gait Analysis Device for Children With Cerebral Palsy
Phase: NA
Conditions: Gait Disorders, Neurologic, Cerebral Palsy
Sponsor: Yonsei University

 
 
1 
 
Cover Page for ClinicalTrials.gov 
 
Document: 
Study Protocol and Statistical Analysis Plan 
 
Official Study Title: 
Development and Feasibility study of the home-based gait rehabilitation service 
by using the insole-type gait measurement device for children with cerebral palsy 
 
NCT Number: 
NCT06461923 
 
Document Date: 
February 3, 2025 
 
 
 
 

 
 
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Prospective Clinical Study Protocol 
 
 
 
1. Title, stage, protocol identification number, revision history, etc 
- 
Title: Development and Feasibility study of the home-based gait rehabilitation service by using the insole-
type gait measurement device for children with cerebral palsy 
 
2. Summary of study plan  
Study objective 
This study aims to assess the usability and satisfaction of utilizing insole gait 
analysis devices for monitoring and providing feedback on the walking status of 
children with cerebral palsy exhibiting walking impairments in a home 
environment. Additionally, adherence to a home-based exercise program 
developed in this study will be evaluated. 
Study design overview 
Investigator-led exploratory clinical study 
Target 
number 
of 
subjects and calculation 
basis 
Ten children with cerebral palsy exhibiting gait disturbances were selected 
Given the lack of prior studies using the same equipment as this study and the 
limited number of similar studies with varying results, it is challenging to 
statistically determine an accurate sample size based on previous research. This 
study aims to explore the clinical significance of data obtained using an insole-
based gait analysis system in a home setting. Therefore, the target sample size 
was set considering clinical conditions.  
Inclusion and exclusion 
criteria 
1) Inclusion criteria 
① Patients diagnosed with cerebral palsy aged 7 to 18 years old 
② Patients classified as Gross Motor Function Classification System level 1 or 2 
③ Individuals who visited Severance Hospital, comprehended the study, agreed 
to participate, and submitted the informed consent form 
 
2) Exclusion criteria 
① Individuals with complications such as severe foot deformities where the 
sensors of the insole gait analysis device cannot be recognized 
② In addition to above, individuals with clinically significant findings deemed 
inappropriate for this study by the study director or person in charge based 
on medical judgment 

 
 
3 
 
Study Methods 
The screening test is conducted after obtaining consent, and it involves assessing 
whether the subject can independently walk more than 10 meters, regardless of 
the use of assistive devices, following an evaluation of their baseline symptoms 
and signs. 
Subjects who pass the screening test are provided with information about their 
current walking status and what constitutes normal walking. Following the initial 
evaluation, they are instructed to participate in the 6-week home exercise program 
and how to record an exercise log. Additionally, researchers provide participants 
with an insole gait analysis device and instruct them on its operation, encouraging 
prolonged usage to ensure that usage time and walking patterns are recorded. 
Based on the collected measurement data, feedback is provided over the phone at 
weeks 3 to 4. After completing the 6-week home exercise program, a final 
evaluation is conducted in the same manner as the initial evaluation. Satisfaction 
with the insole gait analysis device is assessed only at the time of the final 
evaluation. 
Usage and satisfaction with the insole gait analysis device will be analyzed, and 
evaluation indicators will be compared before and after the home exercise 
program. Additionally, adherence to the home exercise program will be evaluated 
through exercise logs. 
Evaluation variable  
1. Primary outcome 
1) 
6-minute Walking Test   
2. Secondary outcomes 
1) 
Body Composition Analysis 
2) 
Grip Strength Test  
3) 
Spatiotemporal Parameters of Walking 
4) 
10-meter Walking Test  
5) 
Pediatric balance scale  
6) 
Gross motor function measurement 
7) 
Korean version of Cerebral Palsy Quality of Life (if the participant is aged 
8 or younger), Korean version of KIDSCREEN-52 Children & Adolescents 
(if the participant is aged over 8), Korean version of KIDSCREEN-52 
Parents (if the participant is aged over 8) 
8) 
(only at the end of the experiment) Satisfaction Survey for the Device 
Data analysis and 
statistical methods 
1. Primary and secondary outcomes: The difference before and after the home-
based exercise program is presented as descriptive statistics, and the change 
in performance is compared through a paired-sample T test if the normality 
assumption is satisfied, and a Wilcoxon singed-rank test if it is not.  

 
 
4 
 
2. Satisfaction evaluation: Satisfaction with the home-based exercise program 
using an insole-type gait analyzer is analyzed and presented using descriptive 
statistics. 
 
3. Study background and theoretical basis 
  
Walking is a crucial daily activity that requires complex coordination of muscular systems [1]. It is 
essential for bone and muscle health, cardiovascular fitness, and activities of daily living, making it an important 
indicator of prognosis and patient function [2, 3]. Gait disturbance is one of the most common symptoms 
observed in neurological diseases, and improving gait function in patients with gait disturbances is also one of 
the primary goals of rehabilitation therapy [4]. In particular, pediatric gait disturbances can arise from various 
and complex causes and symptoms, including paralysis, spasticity, hypokinesia, and ataxia, associated with 
neurological diseases [5]. Unlike adults, children are still growing and developing, necessitating appropriate 
evaluation and rehabilitation therapy at each stage. Notably, reports indicate that once children reach school 
age, their activity levels can decrease by 13% to 53% compared to their typically developing peers [6]. Research 
suggests that this decrease in activity levels can persist into adulthood [7], Studies indicate that this can lead to 
musculoskeletal [8] and cardiovascular complications [9], making comprehensive management essential [10].   
  
Many studies have already explored prescribing exercise under medical supervision or monitoring. Unlike 
the past, when wearable sensors could only monitor heart rate, advancements in miniaturized sensors and 
wireless technology now enable kinematic analysis. As a result, there is a growing trend in research focusing on 
remotely analyzing gait patterns and posture [11]. For patients with gait disturbances, it is important not only to 
be able to walk but also to walk accurately, resembling normal gait as closely as possible. This is significant for 
preventing musculoskeletal disorders and promoting overall health. New technologies are expected to greatly 
aid in enhancing the health of these individuals. However, most of the devices used in research are prototypes, 
and their actual clinical application remains limited [12].  
  
An insole-type gait analysis measurement device monitors gait by placing sensor-equipped insoles inside 
the shoes. This system is relatively inexpensive and easy to use. Additionally, the spatiotemporal parameters of 
gait obtained using this method show a high correlation with the results of 3D gait analysis, which is considered 
one of the most standardized methods for quantitative gait analysis [13]. While there are many studies utilizing 
insole-type gait analysis systems within hospital settings, there is a lack of research on their use in outdoor or 
home environments. Therefore, this study aims to explore the feasibility and efficacy of a home-based gait 
rehabilitation service that provides monitoring and feedback on gait using a commercially available insole-type 
gait measurement device for school-aged children diagnosed with cerebral palsy. 
 
4. Purpose of the study 
  
This study aims to assess the usability and satisfaction of utilizing insole gait analysis devices for 
monitoring and providing feedback on the walking status of children with cerebral palsy exhibiting walking 

 
 
5 
 
impairments in a home environment. Additionally, adherence to a home-based exercise program developed in 
this study will be evaluated. 
 
5. Risk/benefit analysis 
  
The assessment items used in this study are widely utilized in standard clinical settings to compare the 
effects before and after treatment. However, not all tests are performed at every clinical visit; selection depends 
on the clinical physician’s judgment. For the purposes of this research, all validity assessments will be conducted. 
Furthermore, to minimize the risk of falls during testing, the assessments will be conducted under the 
supervision of an examiner.  
The potential risks associated with these minimal hazards are outweighed by the benefits participants will 
gain from the study. Participants will receive information about their muscle mass, walking and balance abilities, 
and feedback on how their gait metrics compare to normal walking standards. Additionally, the real-time 
monitoring of home exercise programs and the collected gait data can contribute to research related to the 
treatment and prognosis of diseases, thereby advancing medical knowledge and improving the quality of care. 
Therefore, the potential benefits obtained through this research are expected to outweigh the risk. 
  
 
6. Number of target audience and basis for calculation  
  
Given the absence of prior studies utilizing the same equipment as this study and the limited number of 
similar studies reporting diverse results, it is challenging to statistically determine an accurate sample size based 
on previous research. This study aims to explore the clinical significance of data obtained using an insole-based 
gait analysis system in a home setting. Taking clinical conditions into consideration, the target sample size has 
been set at 10 participants.  
 
7. Subject selection/exclusion criteria  
1) Inclusion criteria 
① Patients diagnosed with cerebral palsy aged 7 to 18 years old 
② Patients classified as Gross Motor Function Classification System level 1 or 2 
③ Individuals who visited Severance Hospital, comprehended the study, agreed to participate, and 
submitted the informed consent form 
2) Exclusion criteria 
① Individuals with complications such as severe foot deformities where the sensors of the insole gait 
analysis device cannot be recognized 
② In addition to above, individuals with clinically significant findings deemed inappropriate for this study by 
the study director or person in charge based on medical judgment 
 
 
 

 
 
6 
 
8. Information and management of clinical investigational drugs/medical devices 
1) 
Although this study does not involve the use of medical devices, the information on the wellness device used in 
the study is as follows 
 Item name: Insole type gait analyzer 
 Model name: LARN8 
 Classification number: R-R-G34-GS-434 
 Manufacturer: Gilon Co., Ltd.  
 Principle of operation and appearance: This product is designed to assess 
the decline in walking ability and the functional recovery following 
treatment. It consists of both hardware and software (app). When the user 
wears the shoes equipped with the device and starts walking, the 
accelerometer sensor embedded in the device detects the user's 
movements and measures walking speed, walking distance, and step count, 
providing insights into the user's gait pattern. 
2) 
The wellness device used in this study will be managed according to usage precautions and storage methods at 
a designated location (the Motion Analysis Lab on the 2nd floor of Severance Hospital). 
 
9. Study design (test group-control group, allocation, blinding and flow chart, etc.)  
1) 
Overview of study design 
- 
This is a researcher-led, exploratory clinical study designed with random assignment and lasts for 6 weeks. 
2) 
Experimental group 
- 
The insole-wearing group is instructed to wear the insole gait analysis device as frequently and for as long 
as possible during outdoor activities. Participants receive feedback during 3rd to 4th week via telephone. 
Following a period of 6 weeks, an evaluation of the usability and satisfaction of the insole gait analysis 
device will be conducted. 
3) 
Control group 
- 
Not applicable 
4) 
Random assignment 
- 
Not applicable 
 
10. Study method  
1) 
Screening method 
- 
The screening test is conducted after obtaining consent, and it involves assessing whether the subject can 
independently walk more than 10 meters, regardless of the use of assistive devices, following an evaluation 
of their baseline symptoms and signs. 
2) 
Evaluation indicators before and after in intervention program: As the primary outcome measure, the 6-
minute walk test will be used. Secondary outcome measures include body composition analysis, digital grip 

 
 
7 
 
strength measurement, spatiotemporal gait parameters, the 10-meter walk test, the Pediatric Balance Scale, 
the Gross Motor Function Measure, quality of life questionnaires for children with cerebral palsy and their 
parents, and a satisfaction survey. If conducting an assessment is not feasible, the reason for the inability to 
assess will be documented. 
① 6-minute Walking Test 
The 6-minute walk test is a useful indicator for assessing walking endurance and estimating 
cardiopulmonary function. It measures the maximum distance (in meters) that a subject can walk in 6 
minutes. The subject may rest if necessary, but is encouraged to cover the maximum possible distance 
during the test. 
② Body Composition 
To determine the appendicular muscle mass, a body composition analysis based on bioelectrical 
impedance analysis is performed [14]. To correct for differences in muscle mass due to height, the 
appendicular skeletal mass is calculated and divided by the square of the height. 
 
③ Grip Strength Test 
To assess grip strength, which can predict overall muscle strength, the subject follows the examiner's 
instructions and stands in a neutral shoulder position with the elbow fully extended. Then the subject 
grips the dynamometer with maximum force for 5 seconds. Measurements are taken alternately for the 
dominant hand and the non-dominant hand, with each hand being measured three times. The average 
value is used for evaluation. A 60-second rest period between each measurement is provided to prevent 
muscle fatigue [15, 16].  
④ Spatiotemporal Parameters of Walking 
While the subject performs activities at home wearing an insole-type gait analyzer, spatiotemporal 
parameter data of the gait are collected. This data includes the number of steps, calories burned, activity 
time, activity distance, walking speed, stride length, and left-right gait balance. 
⑤ 10-meter Walking Test 
Following the examiner's instructions, the subject walks a total of 14 meters at their usual walking speed, 
with or without assistive devices. The examiner records the time taken to walk 10 meters, starting from 2 

 
 
8 
 
meters after the starting point to 2 meters before the finish line. The walking speed is measured in two 
conditions: comfortable speed and maximal speed (when the subject attempts to walk as quickly as 
possible) [17]. 
 
⑥ Pediatric balance scale 
The assessment tool developed to evaluate functional balance in children consists of the following 
detailed items.  
The subjects perform a total of 14 items according to the examiner's instructions. Each item can be 
attempted up to three times. The examiner records the scores based on the criteria in the following 
assessment sheet [18, 19].  
 
 
⑦ Gross motor function measurement 
The standardized observational assessment tool for measuring gross motor function development in 
children consists of the following evaluation items. The subjects perform 17 lying and rolling items, 20 
sitting items, 14 crawling and kneeling items, 13 standing items, and 24 walking, running, and jumping 
items according to the examiner's instructions. The examiner records the scores based on the criteria in 
the following assessment sheet [20].  

 
 
9 
 
 

 
 
10 
 
  

 
 
11 
 
 
 
⑧ Korean version of Cerebral Palsy Quality of Life (CP-QoL) Parents Report (if the participant is aged 8 or 
younger), Korean version of KIDSCREEN-52 Children & Adolescents (if the participant is aged over 8), 
Korean version of KIDSCREEN-52 Parents (if the participant is aged over 8) 
To assess the quality of life of children with cerebral palsy and their parents, the CP-QoL Parent Report is 
used for subjects under 8 years old. For those aged 8 and above, the KIDSCREEN-52 Children & 
Adolescents and the parent versions are used. The detailed items of each questionnaire are as follows 
[21].  
- 
KIDSCREEN-52 Children & Adolescents  

 
 
12 
 
 
 

 
 
13 
 
 
 

 
 
14 
 
 
 
 
 
 
 

 
 
15 
 
- 
KIDSCREEN-52 Parents  
 

 
 
16 
 
 
 

 
 
17 
 
 
 

 
 
18 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
19 
 
- 
CP-QoL (Parents Report) 
 

 
 
20 
 
 

 
 
21 
 
 

 
 
22 
 
 

 
 
23 
 
 

 
 
24 
 
 

 
 
25 
 
 
 

 
 
26 
 
 

 
 
27 
 
 
 
 
 
 
 
 

 
 
28 
 
⑨ Satisfaction Survey for the Device (only at the end of the experiment) 
Participants will complete a 12-item, 7-point scale satisfaction survey for the insole-type gait analysis 
system based on the Korean version of the Quebec User Evaluation of Satisfaction with Assistive 
Technology (K-QUEST 2.1). This survey is designed to assess user satisfaction, with evaluation items as 
follows [22, 23].  
 
 
 
 
 
 
 
 
Are you satisfied with the size of the device? 
 
 
 
 
 
 
 
Are you satisfied with the weight of the device? 
 
 
 
 
 
 
 
Are you satisfied with how easily you can move 
the device to the desired position? 
 
 
 
 
 
 
 
Are you satisfied with the appearance and design 
of the device? 
 
 
 
 
 
 
 
Are you satisfied with how easy it is to use the 
device? 
 
 
 
 
 
 
 
Are you satisfied with the amount of preparation 
time needed to operate the device? 
 
 
 
 
 
 
 
Are you satisfied with the performance and 
functionality of the device? 
 
 
 
 
 
 
 
Do you feel that the device meets your 
requirements well? 
 
 
 
 
 
 
 
Are you satisfied with the advice given when 
selecting the device? 
 
 
 
 
 
 
 
Are you satisfied with the time it took to receive 
the device? 
 
 
 
 
 
 
 
Are you satisfied with the assistance provided 
when the device experienced malfunctions? 
 
 
 
 
 
 
 
Are you satisfied with the instructions provided for 
the device? 
 
 
 
 
 
 
 
 
 
 

 
 
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3) 
Home-based exercise program education and adherence evaluation 
The researcher educates the participants on the following exercise program. The exercise program is based 
on the exercise recommendations for individuals with cerebral palsy outlined in the ACSM’s Exercise 
Management for Persons with Chronic Diseases and Disabilities 4th edition [24]. 
 
4) 
Participants monitoring methods 
- 
Data collection of participants' gait data through the insole-type gait analysis system is conducted by 
connecting the insole-type gait analysis system to the participant's smartphone, with the measured data 
transmitted to a web server. The medical device company provides the researcher with data sorted by 
product serial number once a week. 
- 
Compliance evaluation of the exercise program will be based on exercise logs completed by the 
participants and their caregivers. Participants will record exercise duration and frequency for each of the five 
components: Warm-up, Flexibility, Aerobic, Strength, and Cool-down. They will also assess their 
performance level as 'weak, moderate, strong' for each component. 
- 
The researcher will monitor participants' activity levels based on the data received from the medical device 
company. They will also compare participants' gait metrics with normal standards and provide feedback via 
telephone once every 3 to 4 weeks. The researcher will verify the stability of data collection and take 
corrective action if any anomalies occur, recording these actions accordingly. 
- 
The extracted gait parameters include the following; 
① Step count: The extracted gait parameter is the step count measured during walking through the 
integration of the insole-type gait analysis system with the smartphone application. Users can view step 
counts per hour, per day, per week, and per month. 

 
 
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② Calorie (Kcal): The unit for calorie expenditure is kcal (kilocalories). Users can view calories per hour, per 
day, per week, and per month. 
③ Activity duration (min): The time spent active while wearing the insole-type gait measurement device, 
measured in minutes. 
④ Activity Distance (km): The distance covered during activity, measured in kilometers. Users can check the 
activity distance per hour, per day, per week, and per month. 
⑤ Walking Speed (m/s): The speed of walking, measured in meters per second. Users can view their 
walking speed per day, per week. 
⑥ Stride Length (cm): Measured in centimeters, users can check the average stride length per day, per week, 
and per month. Stride length is evaluated based on the length relative to the user's height. 
⑦ Walking Balance (Left-Right Disparity %): Walking balance can be evaluated based on the ratio of time 
each foot spends on the ground, measured in percentage. Users can view their walking balance per day, 
per week, and per month.  
 
 
11. Standard medical examination and procedure for registered participants 
For cerebral palsy patients capable of independent walking, regular outpatient visits are conducted to 
assess their physical activity levels through interviews and discussions with both the patient and their caregivers. 
If necessary, verbal education is provided on assistive devices and exercise methods. 
 
12. Study procedures and evaluation 
Phase 
Screening/ 
Intervention 
Intervention 
Intervention/ 
Assessment 
Week 
1 
2 
3 
4 
5 
6 
Written consent 
O 
 
 
 
 
 

 
 
31 
 
 
13. 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. 
 
14. Safety evaluation criteria, evaluation methods, and reporting methods, including adverse effects 
- 
This study plans to monitor safety with the principal investigator serving as the safety inspector to ensure 
participant’s safety. 
- 
As the study involves minimal invasive interventions and poses low risk, monitoring will be conducted 
weekly under the supervision of the principal investigator. Data integrity will be ensured by comparing 
evidence documents, CRFs, and protocols, while reviewing participant safety data. 
- 
Participants can decide to withdraw from the study at any time if they feel discomfort. The principal 
investigator or study coordinator will thoroughly explain and obtain consent from participants before 
enrollment. 
- 
Any violations or deviations from the study protocol will be promptly reported to the IRB with 
documentation, along with the researcher's actions and measures to prevent recurrence. 
Inclusion/ Exclusion criteria 
O 
 
 
 
 
 
Demographic 
information 
and antecedent history 
O 
 
 
 
 
 
Primary outcome 
O 
 
 
 
 
O 
Secondary outcome 
O 
 
 
 
 
O 
Home-based 
exercise 
program 
O 
O 
O 
O 
O 
O 
Phone calls (monitoring and 
feedback purpose) 
O 
O 
O 
O 
O 
O 
Satisfcation evaluation 
 
 
 
 
 
O 

 
 
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- 
Immediate intervention and observation will occur if participants experience distress or new events during 
evaluations. Thorough investigation will be conducted into the cause, following the hospital's standard 
procedures for treatment, which will be reported in interim reports and included in research papers. 
However, considering the low likelihood of future adverse events, additional treatment costs are not 
included in the research budget.  
 
15. Data analysis and statistical considerations 
1) 
Primary and secondary outcomes: The differences between pre- and post-home-based exercise program are 
analyzed using descriptive statistics, presenting mean, standard deviation, median, minimum, and maximum 
values. If the changes in performance before and after the program follow a normal distribution, a paired T-
test is conducted; if not, a Wilcoxon signed-rank test is used for comparison. 
2) 
Satisfaction Evaluation: The satisfaction with the home-based exercise program utilizing smart insoles is 
analyzed using descriptive statistics, presenting mean, standard deviation, median, minimum, and maximum 
values.  
 
16. Measures for protecting personal information and maintaining confidentiality of research data 
1) 
Protection of participant personal information 
- 
When obtaining consent for the research, participants will be explained the research in a separate space 
within the outpatient counseling room of the Department of Rehabilitation Medicine. 
- 
All information collected from the study will remain confidential and will only be used for research purposes. 
Sensitive personal information that can identify individuals will not be shared with anyone outside the 
hospital and will undergo a deidentification process. Deidentification will involve using unique identifiers 
provided to participants for the insole-type gait analysis system, ensuring that extracted data is not 
personally identifiable. The deidentified data will be transmitted to the medical device company. 
Deidentification will only be reversed if necessary for individual treatment-related purposes. The medical 
device company will only have access to the final analysis results, with data ownership retained by the 
hospital.  
2) 
Confidentiality of research data 
- 
Paper documents will be stored in locked cabinets to prevent unauthorized access, and digital data will be 
stored on computers with restricted access, managed by the responsible researcher. 
3) 
Preservation of records  
- 
Research-related data will be preserved for three years in accordance with the regulations of the Bioethics 
Act. Documents containing personal information that have exceeded the retention period will be destroyed 
in accordance with the Personal Information Protection Act. However, if preservation of such data is 
necessary for subsequent research or record accumulation, an extension of the retention period will be 
requested through review by the Institutional Review Board. 
 

 
 
33 
 
17. Management, storage, and disposal measures for human-derived materials and genetic information 
- 
This study does not involve the collection of human-derived materials or genetic information. 
 
18. Participant recruitment method and consent procedure 
- 
Following approval from the IRB of Severance Hospital, recruitment for this study will be conducted among 
visitors to Severance Hospital, who voluntarily decide to participate in the study and provide consent. 
Interviews will be conducted in independent spaces. Participants will be provided with the IRB-approved 
participant information sheet and consent form. 
- 
Adequate explanation about participation in the clinical trial will be provided, and consent forms will be 
filled out in an environment free from coercion. Participants will be informed that they have the right to 
withdraw their consent at any time during the trial, and their decision to participate is voluntary. 
Additionally, during the conduct of research tests, the willingness of participants to continue their 
participation will be confirmed, ensuring that withdrawal of consent is possible at any time based on their 
own will. 
 
19. Protection measures for recruiting vulneralbe participants 
1) 
As vulnerable subjects in clinical trials, ensuring neutrality in providing information and continuously assessing 
understanding to confirm the consent of participants and their guardians. 
 
Ages 7 to 12: Obtain written consent from both the participant and guardian through a consent form 
expressed in appropriate, simple terms for the respective age group. 
 
Ages 13 to 18: Obtain written consent from both the participant and guardian through a consent form 
documented in simple and appropriate language for their level of understanding. 
 
If obtaining written consent is challenging for participants due to upper limb disabilities or similar reasons, 
use alternative methods such as obtaining a check mark indicating the maximum expression of their 
consent. In cases where this procedure is not feasible, obtain verbal consent followed by written consent 
from the caregivers. 
 
If the participant is unable to communicate or incapable of understanding and signing the consent form 
due to intellectual disabilities, only obtain written consent from the caregiver. Evaluate the participant's 
understanding and capacity to consent through questioning about the research content after 
developmental assessment and explanation of the research. 
 
Continuously verify whether the participant and guardian consent to participation in the research and 
explain that they can withdraw consent and discontinue participation in the research at any time. Explain 
that there will be no adverse effects on medical treatment processes due to refusal to participate in the 
research or withdrawal of consent during research participation 
 
 
 

 
 
34 
 
20. Principal investigator’s information, research venue, and duration of study  
1) 
Principal investigator and other research team members 
 
Affiliated organizations 
Name 
Phone/E-mail 
Principal 
investigator 
Severance Hospital 
Juntaek Hong 
+82 010 6517 7526 
/GHDWNSXOR@yuhs.ac 
Research team 
members 
Yongin Severance Hospital 
Na Young Kim 
+82 031 5189 8163 
/Kny8452@yuhs.ac 
Research team 
members 
Severance Hospital 
Yerim Do 
+82 010 7154 6011 
/doyr62@gmail.com 
Research team 
members 
Yonsei University College of 
Medicine 
Seung Ick Choi 
+82 010 8821 5297 
/rehab2@yuhs.ac 
2) 
Research location: Severance Hospital (Seoul, Seodaemun-gu, South Korea, 03722) 
3) 
Research duration: 24 months after IRB approval (e.g., November 2023 – November 2025) 
 
21. Data safety monitoring plan 
  
The safety inspector (Principal Investigator) intends to monitor the overall progress of the research, 
adequacy of participant selection criteria, appropriateness of the consent acquisition process, occurrences of 
deviations from the research protocol, and any adverse events in participants at monthly intervals to ensure the 
completeness of the data.  
 
22. Study plan (schedule table) 
 
Detailed 
developemnt items 
Detailed schedule (months) 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
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 

 
 
35 
 
Subject Recruitment 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
 
 
Conduct of study 
procedures and 
follow-up period 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
 
 
23. References 
1. 
Salzman, B., Gait and balance disorders in older adults. American family physician, 2010. 82(1): p. 
61-68. 
2. 
Fritz, S. and M. Lusardi, White paper:“walking speed: the sixth vital sign”. Journal of geriatric 
physical therapy, 2009. 32(2): p. 2-5. 
3. 
Middleton, A., S.L. Fritz, and M. Lusardi, Walking speed: the functional vital sign. Journal of aging 
and physical activity, 2015. 23(2): p. 314-322. 
4. 
Stolze, H., et al., Prevalence of gait disorders in hospitalized neurological patients. Mov Disord, 2005. 
20(1): p. 89-94. 
5. 
Giladi, N., F.B. Horak, and J.M. Hausdorff, Classification of gait disturbances: distinguishing between 
continuous and episodic changes. Mov Disord, 2013. 28(11): p. 1469-73. 
6. 
Carlon, S.L., et al., Differences in habitual physical activity levels of young people with cerebral 
palsy and their typically developing peers: a systematic review. Disabil Rehabil, 2013. 35(8): p. 647-
55. 
7. 
Waltersson, L. and E. Rodby-Bousquet, Physical Activity in Adolescents and Young Adults with 
Cerebral Palsy. Biomed Res Int, 2017. 2017: p. 8080473. 
8. 
O'Connell, N.E., et al., Incidence of osteoarthritis, osteoporosis and inflammatory musculoskeletal 
diseases in adults with cerebral palsy: A population-based cohort study. Bone, 2019. 125: p. 30-35. 
9. 
McPhee, P.G., et al., Cardiovascular disease and related risk factors in adults with cerebral palsy: a 
systematic review. Dev Med Child Neurol, 2019. 61(8): p. 915-923. 
10. 
Bulekbayeva, S., et al., Cerebral palsy: a multidisciplinary, integrated approach is essential. Lancet 
Glob Health, 2017. 5(4): p. e401. 
11. 
Muro-De-La-Herran, A., B. Garcia-Zapirain, and A. Mendez-Zorrilla, Gait analysis methods: An 
overview of wearable and non-wearable systems, highlighting clinical applications. Sensors, 2014. 
14(2): p. 3362-3394. 
12. 
Ngueleu, A.M., et al., Validity of instrumented Insoles for step counting, posture and activity 
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