Study to Verify the Effectiveness and Safety of the Electrically Powered Orthopedic Exercise Device on Gait Ability in Patients With Gait Disorders : Investigator-Initiated, Single-Center, Single-Group Clinical Trial
Phase: PHASE4
Conditions: Gait Disorders
Sponsor: Yonsei University

 
 
 
Cover page for ClinicalTrials.gov 
 
Name of the document: 
Study protocol and Statistical Analysis Plan 
 
Official Title of the Study: 
A Pilot Study to Verify the Effectiveness and Safety of the 
Electrically Powered Orthopedic Exercise Device on Gait Ability 
in Patients with Gait Disorders: Investigator-Initiated, Single-
Center, Single-Group Clinical Trial 
 
NCT number 
 
 
Date of the document: 
April 9, 2025 
 
 
 
 
 
 

 
Severance: H10_250409 
Prospective Clinical Trial Protocol 
 
1. Study title, stage, plan identification number, revision history, etc. 
- Study title: A Pilot Study to Verify the Effectiveness and Safety of the Electrically Powered Orthopedic Exercise 
Device on Gait Ability in Patients with Gait Disorders: Investigator-Initiated, Single-Center, Single-Group 
Clinical Trial 
- Study phase: phase 4 
2. Summary of study plan 
Research Purpose 
This study aims to evaluate the improvement in gait function of patients with 
gait disorders when using an electrically powered orthopedic exercise device 
compared to when they are not using it. Furthermore, it assesses user satisfaction 
and device safety to explore its feasibility in clinical settings. 
Research design overview 
Investigator-led exploratory clinical study  
Clinical Trial Medical Devices 
Electrically Powered Orthopedic Exercise Device 
Target number of subjects 
and basis for calculation 
30 patients with Gait disorders 
 
This study aims to compare and analyze changes in gait indicators between the 
non-wearing and wearing conditions of the Electrically Powered Orthopedic 
Exercise Device to verify its effectiveness in improving gait function and ensure 
its safety. The target sample size was determined considering clinical setting. 
 
Calculation Basis: The sample size was determined considering clinical 
circumstances with the goal of recruiting three participants per month. 
Selection 
and 
exclusion 
criteria 
1. Selection criteria 
1) Adults aged 19 years or older  
2) Patients experiencing subjective gait or balance disorders  
3) Individuals who visited Yongin Severance Hospital, understood the study, 
voluntarily agreed to participate, and signed the consent form  
4) Patients with a Functional Ambulatory Category (FAC) score of less than 4  
5) Individuals who can sit on the edge of a bed without assistance and stand 
for 10 seconds with or without support  
6) Individuals with sufficient cognitive ability to follow and understand simple 
instructions (Mini-Mental State Examination score ≥ 20) 
 
2. Exclusion criteria 
1) Individuals with contraindications to weight-bearing in the lower 

 
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extremities, such as severe lower extremity joint contractures, osteoporosis, 
or untreated fractures  
2) Individuals who cannot wear the device due to skin diseases or open 
wounds  
3) Individuals with a significant discrepancy in lower extremity length  
4) Individuals with severe lower extremity deformities or joint contractures  
5) Individuals unable to maintain a sitting or standing posture independently  
6) Individuals with severe cognitive impairment (Mini-Mental State 
Examination score < 20), delirium, or severe speech impairment preventing 
cooperation in wearing the device  
7) Individuals unable to stand or walk for extended periods due to underlying 
conditions such as orthostatic hypotension or reduced cardiopulmonary 
function  
8) Pregnant or potentially pregnant individuals  
9) Individuals with other clinically significant conditions deemed inappropriate 
for this study by the principal investigator or research team based on 
medical judgment 
Research Methods 
After obtaining informed consent, clinical information is collected, and a 
screening test is conducted. The screening includes an interview regarding the 
participant’s baseline symptoms and signs, as well as a physical activity 
questionnaire. Participants who pass the screening undergo an evaluation of gait 
function and balance ability without wearing the Electrically Powered Orthopedic 
Exercise Device. Afterward, the patient wears the electrically powered orthopedic 
exercise device for a total of four adaptation sessions. In each session, the patient 
performs short-distance walking within 10 meters while wearing the device to 
explore the appropriate assistive mode and level of support that match their 
physical condition. No evaluations are conducted while wearing the device during 
sessions 1, 2, and 3. After the 4th session, an evaluation identical to the one 
conducted without the device is performed while wearing it, and a satisfaction 
survey is conducted. 
Any device malfunctions are addressed and documented, and the type, severity, 
and frequency of side effects, such as pain associated with device use, are 
recorded. 
The evaluation results from the non-wearing and wearing conditions of the 
Electrically Powered Orthopedic Exercise Device, along with the satisfaction survey 
results, are compared. 

 
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Evaluation variables 
1. Primary evaluation variables 
- 10m walk test 
2. Secondary evaluation variables 
- 6-minute walk test 
- Gait spatiotemporal parameters 
- Timed Up and Go test  
- Berg Balance Scale 
- A satisfaction survey on the use of electric orthopedic exercise devices using a 12-item 
5-point scale based on K-QUEST 
Data analysis and statistical 
methods 
1) Primary and Secondary Evaluation Variables: This study is a preliminary 
investigation into the safety and efficacy of a powered orthopedic exercise 
device. Gait and balance functions are assessed both with and without 
wearing the device. The primary evaluation variable is the walking speed 
measured in the 10m walk test. The results are analyzed using a paired t-test, 
with a significance level of 0.05. If the p-value is less than 0.05, the difference 
before and after wearing the device is considered statistically significant. 
Secondary evaluation variables, including the 6-minute walk test, gait 
spatiotemporal parameters, Timed Up and Go test, and Berg Balance Scale, 
are also analyzed using a paired t-test, with a significance level set at 0.05. 
In addition, a linear mixed model will be used to analyze the data, 
incorporating both the individual characteristics of participants due to 
repeated measures and fixed effects. 
2) Satisfaction Evaluation: The satisfaction survey results are analyzed using 
descriptive statistics, assessing the mean, standard deviation, minimum, and 
maximum values for each item. If the mean score for an item is 4 or higher, 
it is considered a positive evaluation; if it is 2 or lower, it is considered a 
negative evaluation. 
 
3. Research background and theoretical basis 
Aging is a global trend, and consequently, the prevalence of age-related diseases is increasing.1,2 Gait disorders 
are common among the elderly and can result not only from various underlying conditions affecting gait but also 
from the decline in physiological and neurological functions associated with the normal aging process. 3 
Gait is a fundamental daily activity that requires the coordinated integration of the central and peripheral nervous 
systems, as well as the musculoskeletal system. Therefore, impairments in any of these systems—including the 

 
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nervous, cardiovascular, respiratory, or musculoskeletal systems—can lead to gait dysfunction.4-6 Gait disorders 
negatively impact quality of life by increasing the risk of falls, reducing the ability to perform activities of daily living 
(ADLs), and limiting physical activity.3,7 Accordingly, various approaches to maintaining and improving gait function 
in older adults are being actively explored.8 
Currently, gait aids such as canes and walkers are commonly used to support individuals with gait impairments. 
These devices help redistribute body weight by providing a broader base of support, thereby assisting with balance 
and stability. However, they do not directly facilitate the movement of the lower limbs. To enhance gait function, 
numerous studies have investigated repetitive lower-limb movement training using bicycles or robotic devices. 
However, the extent of functional improvement resulting from such training remains unclear, and the long-term 
efficacy is still uncertain. 9  
Recent advancements in sensing technology for joint motion and actuator efficiency have led to the development 
of wearable assistive devices that are significantly more compact and lightweight compared to conventional robotic 
systems. This study aims to evaluate the effectiveness of a newly developed electrically powered orthopedic exercise 
device in patients with gait disorders by assessing changes in gait parameters upon wearing the device, thereby 
exploring its clinical feasibility. 
 
4. Purpose of the study 
This study aims to assess whether gait function improves in patients with gait disorders when using an electrically 
powered orthopedic exercise device compared to when not using it. It also evaluates the device’s effectiveness, user 
satisfaction, and safety to explore its feasibility in clinical settings. 
 
5. Risk/Benefit Analysis 
The participant's gait ability, both with and without the electrically powered orthopedic exercise device, will be 
assessed using the 10m Walk Test. All additional gait and balance assessments conducted in this study are widely 
used in clinical practice and pose minimal medical risk. To minimize the risk of falls during the assessment, sufficient 
practice will be conducted under the supervision of the tester before the test, and the test will be conducted in an 
environment with a safety bar installed.  
Through this study, participants will receive information regarding their physical function, including motor and 
balance abilities, as well as gait parameters. The accumulated data collected during the study will contribute to the 
improvement and advancement of gait rehabilitation devices and the development of rehabilitation services. 
Additionally, the findings will be utilized in research related to disease treatment and prognosis, ultimately 
contributing to medical advancements and the improvement of clinical care quality. Therefore, the potential benefits 

 
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of this study are expected to outweigh any associated risks. 
 
 
6. Number of Target Audience and Basis for calculation 
This study will be conducted on all patients visiting Yongin Severance Hospital who agree to participate in the study 
and meet the selection criteria. Yongin Severance Hospital Among the patients, the goal was to recruit 3 subjects 
per month, and the target number of subjects was set at 30 considering the dropout rate and clinical conditions. 
 
7. Criteria for selection/exclusion of subjects 
(1) Selection criteria 
1) Adults aged 19 years or older  
2) Patients experiencing subjective gait or balance disorders  
3) Individuals who visited Yongin Severance Hospital, understood the study, voluntarily agreed to participate, and 
signed the consent form  
4) Patients with a Functional Ambulatory Category (FAC) score of less than 4  
5) Individuals who can sit on the edge of a bed without assistance and stand for 10 seconds with or without 
support  
6) Individuals with sufficient cognitive ability to follow and understand simple instructions (Mini-Mental State 
Examination score ≥ 20) 
(2) Exclusion criteria 
1) Individuals with contraindications to weight-bearing in the lower extremities, such as severe lower 
extremity joint contractures, osteoporosis, or untreated fractures  
2) Individuals who cannot wear the device due to skin diseases or open wounds  
3) Individuals with a significant discrepancy in lower extremity length  
4) Individuals with severe lower extremity deformities or joint contractures  
5) Individuals unable to maintain a sitting or standing posture independently  
6) Individuals with severe cognitive impairment (Mini-Mental State Examination score < 20), delirium, or 
severe speech impairment preventing cooperation in wearing the device  
7) Individuals unable to stand or walk for extended periods due to underlying conditions such as 

 
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orthostatic hypotension or reduced cardiopulmonary function  
8) Pregnant or potentially pregnant individuals  
9) Individuals with other clinically significant conditions deemed inappropriate for this study by the principal 
investigator or research team based on medical judgment 
8. Research equipment 
Information on the equipment and management methods used in this study are as follows. 
(1) Electric orthopedic exercise device (Angel SUIT H10) 
1) Product name: Electric orthopedic exercise device 
2) Classification number: A67020.02 
3) Packaging unit: 1 set 
4) Medical device class: Class 2 
5) Model: Angel SUIT H10 
6) Manufacturer: Angel Robotics Co., Ltd. 
7) Appearance 
8) Principle of action, method of use, precautions for use - Refer 
to the attached document 
9) Product License Number: 25-4093 
 
(2) Device Management 
The Electrically Powered Orthopedic Exercise Device used in this study will be stored in the Rehabilitation Function 
Testing Room. 
1) Security 
The device, provided by Angel Robotics, will be stored according to the storage environment conditions specified 
in the instructions. It will be managed in a designated area equipped with a locking mechanism, located on the 
2nd floor of the Rehabilitation Function Testing Room at Yongin Severance Hospital. 
2) Infection Control 
The device manager will perform thorough disinfection procedures before and after each use to minimize the 
risk of cross-infection between participants. Additionally, participants will be instructed to use hand sanitizer 

 
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available in the testing area to ensure proper personal hygiene management before wearing the device. 
3) Device Receipt and Inventory Management 
Prior to the start of the study, the electrically powered orthopedic exercise device will be received through a 
handover process between the research team and Angel Robotics personnel. The medical device manager will 
manage the device’s location and condition through inventory logs and conduct regular inventory checks. 
4) Application Method and Duration per Participant 
Each participant undergoes a total of four sessions using the electrically powered orthopedic exercise device 
according to the manual, with each session lasting 20 minutes. After the final session, an evaluation is conducted 
while wearing the device, which takes approximately 60 minutes. 
5) Return and Inventory Log 
After use, the device will be returned to the Rehabilitation Function Testing Room. Upon return, its condition will 
be inspected, and the usage date and status will be recorded in the inventory log. 
 
9. Study design (test group·control group, allocation, blinding and flow chart, etc.) 
(1) Research design overview 
 This is a researcher-led exploratory study. The subject's gait indices (walking speed, spatiotemporal parameters, 
walking endurance, etc.) were evaluated while the subject was not wearing the electric orthopedic exercise device 
and then while wearing it. The collected gait indices were analyzed to determine their validity and safety. This is a 
preliminary study to evaluate.  
(2) Experimental Group and Evaluation Procedures 
1) Participant Selection: 
This study includes a single test group with a total of 30 participants. The selection of participants for the electrically 
powered orthopedic exercise device and the overall study process will be conducted under the prescription and 
guidance of a rehabilitation medicine specialist, and supervised by assistants (physicians and occupational 
therapists). The examiner will collect clinical information and conduct a screening assessment for each participant. 
2) Evaluation Phase Without Device: 
After the screening test, participants undergo assessments of walking ability and balance without wearing the 
electrically powered orthopedic exercise device. A 10-minute rest period is provided between each assessment. 
If the participant wishes, additional rest time is allowed and recorded in the case report form. The assessments 
include the 10-Meter Walk Test, the 6-Minute Walk Test, the Timed Up and Go Test, and the Berg Balance Scale. 
These evaluations are conducted in the rehabilitation function testing room on the second floor of the facility 

 
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under the supervision of the research team (physician and either a physical or occupational therapist). 
3) Pre-Adaptation Phase: 
After the evaluations without the device, a total of four adaptation sessions are conducted, during which the 
participant wears the device and performs short-distance walking within 10 meters. These sessions are designed 
to help the participant become familiar with the operation and wearing method of the H10 device. Appropriate 
device settings are configured for each participant to minimize any potential inexperience or anxiety during use. 
Participants must complete all four adaptation sessions, and each session should be conducted within a two-
week interval.  
4) Evaluation Phase:  
After completing all four adaptation sessions, participants undergo assessments of walking ability and balance 
while wearing the electrically powered orthopedic exercise device. A 10-minute rest period is provided between 
each assessment. If the participant wishes, additional rest time is allowed and recorded in the case report form. 
The assessments include the 10-Meter Walk Test, the 6-Minute Walk Test, the Timed Up and Go Test, and the 
Berg Balance Scale. These evaluations are conducted in the rehabilitation function testing room on the second 
floor of the facility under the supervision of the research team (physician and either a physical or occupational 
therapist). After the evaluations are completed, a usability and satisfaction survey regarding the electrically 
powered orthopedic exercise device is conducted. 
(3) Random assignment and control group 
This pilot study had a single-group design and did not include randomization or a control group. 
 
 
 
10. Study Method 
(1) Screening method 
 The examiner will interview the participant regarding baseline symptoms and signs, check vital signs to ensure the 
participant’s medical stability, and then proceed with the following assessments. 
1) Korea-Mini Mental State Examination 
A test that assesses the degree of overall cognitive impairment, taking into account a person's level of 
education 10, and the test assesses time and place perception, attention and calculation, memory, language, 
and spatial and temporal organization. The examiner asks questions corresponding to the items on the test 
sheet below and record a score for the answers. 

 
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2) Functional Ambulation Index Evaluation (Functional Ambulation Category) 
Assessment of the subject's walking function.11 The examiner observes the subject's gait and records a score 
based on the criteria in the assessment sheet below. 
Stage 
Desciption 
0 
Unable to walk or requires assistance from two or more people. 
1 
Requires continuous support from one person to maintain balance or shift body weight. 
2 
Requires intermittent assistance from one person to aid with balance or coordination. 
3 
Requires supervision or verbal cues without physical contact. 
4 
Able to walk independently on level surfaces but needs assistance on stairs, slopes, or uneven ground. 
5 
Able to walk independently. 
3) Manual Muscle Test (Medical Research Council Scale) – Hip Joint, Knee Joint, Ankle Joint 

 
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The participant's muscle strength is assessed by group according to the criteria in the table below.12 The 
participant's posture is positioned accordingly, and the evaluation scores are recorded. 
 
Joint 
Muscle 
Right 
Left 
Joint 
Muscle 
Right 
 
Left 
Hip 
Flexors 
 
 
Knee 
Flexors 
 
 
 
Extensors 
 
 
Extensors 
 
 
 
Abductors 
 
 
Ankle 
Dorsi-flexors 
 
 
 
Adductors 
 
 
Plantar-flexors 
 
 
 
Int. rotators 
 
 
Foot 
Invertors 
 
 
 
Ext. rotators 
 
 
Evertors 
 
 
 
4) Range of Motion (ROM) Assessment – Lower Extremities 
The participant's range of joint motion is assessed13, with angles recorded according to the form below while 
the participant is in a supine position. 

 
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5) Korean version of the International Physical Activity Questionnaire (K-IPAQ) 
Tests that assess various aspects of an individual's daily physical activity14, 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'. 
 
6) Cybex Isokinetic Exercise Test 
The Cybex isokinetic exercise test measures lower limb muscle strength and exercise capacity.15 Participants 

 
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perform knee extension movements from a 90-degree to a 0-degree angle at a speed of 60 degrees per second 
for 5 repetitions and at 150 degrees per second for 15 repetitions. The test evaluates the following parameters 
of lower limb strength: Peak Torque, Total Work, Average Power per Repetition, and Fatigue Index. 
 
 
7) Pregnancy Questionnaire 
The examiner (a licensed physician) will conduct a pregnancy questionnaire to determine whether the 
participant is currently pregnant or has the potential to be pregnant. This assessment will include inquiries 
about the date of the participant’s last menstrual period and their average menstrual cycle. 
 
(2) Evaluation of Gait Function and Balance Ability in Non-Wearing and Wearing Conditions of the Electrically 
Powered Orthopedic Exercise Device 
Participants will perform each of the following assessments once under both conditions: 
A. Non-Wearing Condition (Off Status) 
B. Wearing Condition (On Status) 
1) Primary Evaluation Indicator 
① 10-Meter Walk Test 
The 10-Meter Walk Test16 is used to assess gait speed in patients undergoing rehabilitation for neurological and 

 
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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) Participants are informed that their walking speed will be measured over the 10-meter section and are 
instructed to walk at a comfortable pace. 
 
2) Secondary Evaluation Indicator 
① Timed Up and Go (TUG) Test 
 This test17 evaluates both gait speed and balance ability during walking. The assessment is conducted as follows: 
a) Place a chair with armrests (46 cm in height) and position a cone 3 meters away from the chair. Instruct the 
participant to sit in the chair. 
b) During the preparation phase, the participant should sit with their back against the chair and arms resting on 
the armrests. Upon the command "Start," the participant stands up, walks 3 meters, turns around the cone, walks 
back to the starting point, and sits down again. 
 
 
 ② 6-Minute Walk Test 

 
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Participants perform the 6-Minute Walk Test, which closely simulates daily walking activities,18 while wearing an 
insole-type gait analyzer. The examiner compares the average parameter data extracted from the analyzer with 
normal gait standards to provide feedback on the participant’s walking. This test assesses gait endurance and is 
conducted as follows: 
a) Set up colored cones marking a 30-meter straight path on the floor and prepare a stopwatch. 
b) Instruct the participant to walk back and forth along the 30-meter path as many times as possible within 6 
minutes. 
c) Inform the participant that they may rest or stop during the test if needed. Only permitted phrases such as 
"You’re doing well" or "Keep going" should be used for encouragement. 
d) The examiner records the total distance covered, abnormal gait patterns, and the time of occurrence of any gait 
deviations. 
 
 
③ Berg Balance Scale (BBS) 
 This test assesses both static and dynamic balance.19 The examiner instructs the participant to perform the following 
14 tasks and evaluates their performance based on the scoring criteria for each item. 

 
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④ Spatiotemporal Parameters of Gait : While the participant performs the test wearing an insole-type gait analyzer, 
spatiotemporal gait parameters20 are collected and recorded. These parameters include total step count, cadence, 

 
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walking speed, walking distance, and stride length. 
a) Step Count: The total number of steps taken during walking. 
b) Cadence: The number of steps taken per minute, measured in steps per minute (spm). 
c) Self-Selected Walking Speed: The participant’s walking speed when walking naturally at a comfortable pace. 
d) Distance: The total distance covered during walking, measured in meters (m). 
e) Stride Length: The distance between the heel of one foot to the heel of the same foot during consecutive 
steps. Measured in meters (m), stride length is adjusted for height to account for differences in body size. 
 
(3) Recording of Adverse Events and Device Malfunctions 
1) The examiner records the type and frequency of any safety incidents that occur while the participant is walking, 
as well as the reasons for any device malfunctions. 
2) In cases where side effects, such as pain, occur, the following details are investigated and documented: Type of 
side effect, Severity, Frequency of occurrence, Name of adverse event, Onset and resolution dates, Nature of the 
side effect, Causal relationship with device use 
 
(4) Satisfaction Evaluation 
Participants will complete a satisfaction survey regarding the Electrically Powered Orthopedic Exercise Device, 
based on the Korean version of the Quebec User Evaluation of Satisfaction with Assistive Technology (K-QUEST 
2.0).21 The survey consists of 10 items, each rated on a 5-point scale to assess satisfaction with the assistive device 
and related services. Participants are instructed to provide reasons if they select any response other than "Very 
Satisfied”. 
 
1: Very unsatisfied. 2: Not satisfied 3: Average 4: Satisfied. 5: Very satisfied 
 
One 
2 
3 
4 
5 
Are you satisfied with the specifications (size, height, length, width) of the smart insole? 
reason : _________________________________________________________________________ 
 
 
 
 
 
How much does the smart insole weigh? 
reason : _________________________________________________________________________ 
 
 
 
 
 
Is it convenient to adjust (fix and lock) the parts (accessories) of the smart insole? 
reason : _________________________________________________________________________ 
 
 
 
 
 

 
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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 professional service (information and precautions) you received while 
using the smart insole? 
reason : _________________________________________________________________________ 
 
 
 
 
 
 
- Among the 12 items regarding satisfaction, please tick 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 
 
 
(5) Definition of Analysis Population, and Management Plan for Missing and Outlier Data 
1) Definition of Analysis Population 
The analysis population includes all participants who have completed the evaluations of gait and balance 

 
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abilities under both non-wearing and wearing conditions of the Electrically Powered Orthopedic Exercise Device. 
Data will be analyzed in conjunction with participants’ age, diagnosis, physical function assessments, and other 
extracted information. 
2) Management Plan for Missing and Outlier Data 
If missing data occur due to participant withdrawal or dropout, a Complete Case Analysis will be used, analyzing 
only fully observed cases. Data from sessions with missing values will be excluded from the analysis. Outliers 
identified through boxplots and interquartile ranges will also be excluded to maintain data integrity and 
enhance the accuracy and reliability of the research. Information on participants excluded from the analysis will 
be documented. 
 
(6) Pre- and Post-Condition Comparative Analysis 
Upon completion of all evaluations under both non-wearing and wearing conditions of the Electrically Powered 
Orthopedic Exercise Device, the examiner will perform a comparative analysis of the collected participant data using 
a paired t-test. A significance level of p < 0.05 will be used as the criterion for statistical significance. In addition, a 
linear mixed model will be used to analyze the data, incorporating both fixed effects and individual variability of 
participants resulting from repeated measurements. 
 
11. Research Procedure and Evaluation 
Phase 
Screening/Assessment/Adjustment 
Adjustment 
Adjustment 
Adjustment/Assessment 
Session 
1 
2 
3 
4 
Written consent 
form 
O 
 
 
 
Inclusion/Exclusion 
Criteria 
O 
 
 
 
Clinical Information 
Collection and 
Screening 
Assessment 
O 
 
 
 
Primary Outcome 
Measure Assessment 
O 
 
 
O 
Secondary Outcome 
Measure Assessment 
O 
 
 
O 

 
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Wearing the 
electrically powered 
orthopedic exercise 
device 
O 
O 
O 
O 
Satisfaction survey 
 
 
 
O 
*Each session should be conducted within a two-week interval. 
12. Criteria for study discontinuation and withdrawal 
(1) Termination and early suspension 
1) If a subject participating in the study withdraws consent before the end of the study 
- If consent is withdrawn, only the research participant information collected up to that point will be used for 
research. Stored for 3 years after completion of research and then destroyed 
(2) Drop out in the middle 
1) If the subject or his/her legal representative requests discontinuation of participation in the clinical trial 
2) If serious side effects occur 
3) If the medical team determines that the subject has a serious medical need that prevents the clinical 
study from continuing. 
4) If used concurrently with surgery, drugs, or other medical devices that may affect safety and efficacy 
evaluation 
5) If the subject does not follow the investigator's instructions or does not comply with the provisions of the 
consent form, which affects the evaluation of the effectiveness. 
6) In cases where continuous observation is not possible due to the subject’s non-participation 
7) If other clinical trial personnel determine that there is a problem with the clinical trial progress 
8) If a serious illness or accident that may affect the patient's function occurs during the study period 
We will reconfirm the voluntary intention of the research participant to determine whether it is not subject to 
early discontinuation of the study, and if the participant is still willing to provide information to the study, the 
information collected up to the point of discontinuation will be anonymized. Can be used for research 
 
 
 
13. Safety evaluation criteria, evaluation methods, and reporting methods including adverse reactions 

 
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(1) Safety Monitoring and Evaluation : To ensure participant safety, the principal investigator will act as the safety 
monitor and conduct ongoing safety evaluations 
1) As this is a preliminary case study with minimal invasive procedures and low risk, monitoring will be conducted 
under the supervision of the principal investigator. Source documents, Case Report Forms (CRF), and the study 
protocol will be cross-checked to ensure data integrity and review participant safety data. 
2) Participants have the right to withdraw from the study at any time if they experience discomfort. The principal 
investigator or study personnel will fully explain this right and obtain confirmation during the consent process. 
(2) Violation and Deviation Reporting 
In the event of study violations or deviations, the situation, corrective actions, and recurrence prevention measures 
will be promptly reported to the Institutional Review Board (IRB) in writing. 
If a participant sustains an injury or if a new incident occurs during the evaluation, immediate treatment and 
monitoring will be provided, along with a thorough investigation into the cause. Treatment will follow the hospital’s 
standard procedures. These incidents will be included in interim reports and documented in the study publication. 
Given the low likelihood of future adverse events, no additional research budget has been allocated for further 
treatment costs. 
 
14. Data Analysis and Statistical Considerations 
(1) Primary and Secondary Evaluation Variables : Differences in gait function and balance ability between the non-
wearing and wearing conditions of the Electrically Powered Orthopedic Exercise Device will be analyzed using 
descriptive statistics. The analysis will present the mean, standard deviation, median, minimum, and maximum values. 
Changes in performance will be compared using a paired t-test. In addition, a linear mixed model will be used to 
analyze the data, incorporating both the individual characteristics of participants due to repeated measures and 
fixed effects. 
(2) Satisfaction Evaluation : Satisfaction with the Electrically Powered Orthopedic Exercise Device will be analyzed 
using descriptive statistics to determine the mean, standard deviation, minimum, and maximum values for each 
item. (An average score of 4 or higher will be interpreted as positive satisfaction, an average score of 2 or lower 
will be interpreted as negative satisfaction) 
 
 
 
 
15. Measures to protect personal information and maintain confidentiality of research data 

 
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(1) Protection of the subject’s personal information 
When seeking consent for a study, the study is explained to the subject and consent is obtained in a separate space 
in the consultation room of the rehabilitation medicine outpatient clinic. 
All information collected from this study will be kept confidential and will not be disclosed to anyone other than 
the research staff involved in the study. And, it will be used only for research purposes. Sensitive personal information 
that can identify individuals will not be shared with institutions outside the hospital and will undergo a 
deidentification process regarding whether or not personal information will be provided to third parties. 
Anonymization is the subject It is done by using a unique number, and 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 the 
device company. Ownership of the data belongs to the hospital.  
(2) Maintaining confidentiality of research data 
In the case of document materials, they will be stored in a locked device to prevent exposure to others, and stored 
on a computer with restricted access, and managed by the researcher in charge. 
(3) Preservation of records 
In accordance with the Enforcement Rules of the Bioethics and Safety Act, research-related materials involving 
human subjects must be retained for three years after the conclusion of the study. Documents containing personal 
information will be destroyed after the retention period following Article 16 of the Enforcement Decree of the 
Personal Information Protection Act. However, if further retention of the data is necessary for follow-up studies or 
record accumulation, an extension may be approved through review by the institutional committee. 
 
16. Management, storage, and disposal plans for collection of human-derived materials, genetic information, 
etc. 
 This study does not collect human-derived materials or genetic information. 
 
17. Method of recruiting subjects and consent procedures 
 After approval from Yongin Severance Hospital IRB, Yongin Severance Hospital Among the visitors, those who 
voluntarily decided to participate in this study and agreed to participate were interviewed in a private space, 
provided with an IRB-approved explanatory document for the subjects, and consent forms were obtained. 
After providing sufficient explanation about clinical trial participation, consent forms should be written in a non-
oppressive environment, and when writing the consent form, it should be explained that consent can be withdrawn 
at any time at will, so that participants can participate in the clinical trial. In addition, the willingness to participate 

 
Severance: H10_250409 
in the study should be confirmed during the research test, so that consent can be withdrawn at any time at will. 
 
18. Protection measures when recruiting vulnerable subjects 
 This study does not recruit vulnerable subjects.  
 
19. Information on the principal investigator and participating researchers, the location of the research, and 
the research period. 
(1) Research Director 
name 
Affiliation 
specialty 
spot 
phone call 
Kim Na-
young 
Yonsei University 
Medical school 
Yongin Severance 
Hospital 
Rehabilitation 
Medicine 
Assistant 
Professor 
031-5189-8163 
Kny8452 @yuhs.ac 
 
(2) Test Manager  
The test manager checks whether the subjects at the test institution meet the selection criteria and manages the 
overall process of the experiment. 
name 
Affiliation 
specialty 
spot 
phone call 
Kim Na-
young 
Yonsei University 
Medical school 
Yongin Severance 
Hospital 
Rehabilitation 
Medicine 
Assistant 
Professor 
031-5189-8163 
Kny8452 @yuhs.ac 
Yang Hui-
woo 
Yonsei University 
Industry-Academic 
Cooperation 
Foundation 
Occupational 
therapy 
Researcher 
010-7360-4439 
Rehab5@yuhs.ac 
(3) Device Manager 

 
Severance: H10_250409 
name 
Affiliation 
spot 
phone call 
Yang Hui-
woo 
Yonsei University Industry-Academic 
Cooperation Yonsei University 
Medical school 
Researcher 
010-7360-4439 
Rehab5@yuhs.ac 
 
20. Research location and period 
(1) Location of research 
Institution name 
location 
phone call 
Yonsei University College 
of Medicine 
Yongin Severance 
Hospital 
Giheung -gu, Yongin-si, Gyeonggi-do 
Dongbaekjukjeon-daero 363 (Middle 
East) 
031-5189-8891 
(2) Period 
12 months after IRB approval 
 
 
 
21. Data Safety Monitoring Plan 
Safety inspector (The principal investigator) will monitor the overall progress of the study, including the status of 
the study, whether the selection criteria for the enrolled subjects are met, the appropriateness of the consent 
acquisition procedure, whether there are any violations/deviations from the study plan, and whether there are any 
adverse reactions in the subjects, at monthly intervals, to ensure the completeness of the data. 
 
22. Research implementation plan (schedule) 
Development details 
Detailed progress schedule (months ) 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
1 1 1 2 

 
Severance: H10_250409 
Research plan and IRB 
approval 
█ 
 
 
 
 
 
 
 
 
 
 
 
Recruitment of subjects 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
 
Research procedure 
performance and follow-
up period 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
 
 
 
 
 
 
 
 
 
 
 
 
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