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

 
Severance : H10_20250409 
 
 
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 Who Have Undergone Hip Surgery: Investigator-
Initiated, Single-Center, Single-Group Clinical Trial 
 
NCT number 
 
 
Date of the document: 
April 9, 2025 
 
 
 
 

 
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Prospective Clinical Study Protocol 
 
1. Study title, stage, protocol 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 Who Have Undergone Hip Surgery: Investigator-Initiated, Single-
Center, Single-Group Clinical Trial 
- Study phase : phase 4 
 
2. Summary of study plan 
Study objective 
 This study aims to evaluate the clinical feasibility of the Electrically Powered 
Orthopedic Exercise Device in patients who have undergone hip surgery by 
comparing gait function between non-wearing and wearing conditions. The study 
will assess the effectiveness of gait function improvement, device safety, and 
participant satisfaction. 
Study design overview 
Investigator-initiated exploratory clinical study 
Pilot study 
Investigational Medical 
Device 
Electrically Powered Orthopedic Exercise Device 
Target 
Sample 
Size 
and 
Calculation Basis 
Sample Size : 30 patients who have undergone hip surgery 
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 and safety in improving gait function in 
patients who have undergone hip surgery. The target sample size has been 
determined considering clinical circumstances. 
 
Calculation Basis : The sample size was determined considering clinical 
circumstances with the goal of recruiting three participants per month. 
Inclusion 
and 
exclusion 
criteria 
1. Inclusion Criteria 
1) Adults aged 19 or older 
2) Individuals who have undergone hip surgery due to hip osteoarthritis, 
avascular necrosis of the femoral head, or hip fracture 
3) Individuals who are at least two days post-hip surgery and are assessed 
to be medically stable 

 
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4) Adequate cognitive ability (Korean Mini-Mental State Examination score 
≥ 20) 
5) Able to sit at the edge of a bed without assistance and stand for 10 
seconds regardless of support 
6) Functional Ambulatory Category (FAC) score of 1–3 
7) Participants who visited Yongin Severance Hospital, understood the study, 
and signed informed consent 
2. Exclusion Criteria 
1) Individuals who, after undergoing hip surgery, present with exudate at the 
surgical site or report symptoms such as heat, redness, swelling, or severe 
pain at the affected area  
2) Contraindications for lower limb weight-bearing such as severe joint 
contractures, osteoporosis, or untreated fractures 
3) Progressive or unstable brain diseases or neurological paralysis from 
stroke 
4) Active infections or open wounds hindering device use 
5) Significant leg length discrepancies 
6) Severe deformities or contractures in the lower extremities 
7) History of poliomyelitis 
8) Inability to maintain seated or standing positions independently 
9) Severe spasticity (Modified Ashworth Scale grade ≥ 2) 
10) Bone metastases from cancer 
11) Severe internal diseases affecting device use (e.g., cardiovascular or 
respiratory diseases) 
12) Cognitive impairments preventing cooperation with device use 
13) Complaints of device-related side effects or potential rehabilitation 
discontinuation(e.g., severe obesity, skeletal deformity) 
14) Patients who are determined to be pregnant or potentially pregnant 
based on the medical interview 
15) Any other clinically significant findings deemed inappropriate by the 
investigator 
Study 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 

 
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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. 
Evaluation variable 
1. Primary Evaluation Variable 
• 
10-Meter Walk Test 
2. Secondary Evaluation Variable 
• 
6-Minute Walk Test 
• 
Timed Up and Go (TUG) Test 
• 
Berg Balance Scale (BBS) 
• 
Spatiotemporal Parameters of Gait 
• 
K-QUEST-based 10-question, 5-point scale satisfaction survey related to the 
use of Electrically Powered Orthopedic Exercise Device 
Data analysis and statistical 
methods 
1. Primary and Secondary Evaluation Variables: 
 This pilot study explores the effectiveness and safety of the Electrically 
Powered Orthopedic Exercise Device by evaluating gait function and balance 
ability in both non-wearing and wearing conditions. The primary evaluation 
variable is the gait speed measured during the 10-Meter Walk Test. The 
measured results are compared and analyzed using a paired t-test, with a 
significance level set at p < 0.05, indicating a significant difference before and 
after wearing the device. The secondary evaluation variables include the 6-
Minute Walk Test, spatiotemporal gait parameters, Timed Up and Go (TUG) 
Test, and Berg Balance Scale (BBS), which are also analyzed using paired t-

 
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tests with the significance level set at p < 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: 
 User satisfaction with the Electrically Powered Orthopedic Exercise Device is 
analyzed using descriptive statistics. The mean, standard deviation, minimum, 
and maximum values of each item are calculated. A mean score of 4 or higher 
is interpreted as positive satisfaction, while a score of 2 or lower is considered 
negative satisfaction. 
 
3. Research background and theoretical basis 
Gait is an essential daily activity performed through the complex coordination of the central and peripheral nervous 
systems and the musculoskeletal system.1 Gait disorders can negatively affect quality of life, increase the risk of falls, 
decrease the ability to perform daily activities, and limit physical activity.2 Gait disorders can result from various 
musculoskeletal conditions, with hip osteoarthritis, avascular necrosis of the femoral head, and hip fractures being 
the most representative causes.3  
In the early stages of hip osteoarthritis, avascular necrosis of the femoral head, or non-severely displaced hip 
fractures, various intervention therapies, including rehabilitation exercise therapy and injection treatments, can be 
attempted.4-8 However, these intervention therapies merely alleviate symptoms and cannot prevent disease 
progression. Consequently, most patients eventually experience thinning of the full-thickness hip cartilage, collapse 
of the femoral head, nonunion, or worsening displacement, which leads to restricted hip range of motion. As a 
result, lower limb muscle weakness and functional decline occur, ultimately requiring hip surgeries such as total hip 
arthroplasty or open reduction and internal fixation.9 According to OECD statistics, more than one million total hip 
arthroplasty (THA) procedures are performed worldwide each year, with a particularly increasing trend in developed 
countries.10 Although most patients experience a recovery in gait ability after hip surgery, some show a slower 
recovery rate or fail to achieve normal walking.11 It has been reported that over 80% of function is recovered by 
three months after surgery; however, during this period, patients experience limitations in performing daily 
activities.12 Additionally, reduced hip extension strength and range of motion in the operated hip can lead to 
asymmetrical lower limb coordination.13-14 As a compensatory mechanism, excessive weight-bearing on the non-
operated limb may occur, increasing the risk of overloading the non-operated hip.15-17 This may lead to the 
development of osteoarthritis in the non-operated limb and has also been reported to increase the risk of falls.18-
20 Therefore, various methods are being studied to facilitate gait function recovery after hip surgery and promote 
an early return to daily activities. 
With recent advancements in joint motion sensing and actuator efficiency, simpler and lighter wearable exercise 
assistive devices have been developed compared to traditional robots. Therefore, this study aims to explore the 
clinical feasibility of the Angel Suit H10 (Angelrobotics, Seoul, Korea) by assessing whether wearing the Electrically 

 
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Powered Orthopedic Exercise Device improves gait function in patients who have undergone hip surgery, along 
with evaluating user satisfaction and device safety. 
 
4. Purpose of the study 
 This study aims to investigate the clinical feasibility of the Electrically Powered Orthopedic Exercise Device in 
patients who have undergone hip surgery by comparing gait function between non-wearing and wearing conditions. 
The evaluation focuses on the device’s effectiveness in improving gait function, its safety, and participant satisfaction. 
 
5. Risk/benefit analysis 
The 10-Meter Walk Test is used in this study to evaluate gait function under both non-wearing and wearing 
conditions of the Electrically Powered Orthopedic Exercise Device. Other assessments of gait function and balance 
ability are also conducted, all of which are widely used in clinical settings and carry very low medical risk. To 
minimize the risk of falls during the tests, participants will undergo sufficient practice under the examiner’s 
supervision before the evaluation and perform the tests in an environment equipped with safety bars. This device 
is designed to assist thigh muscle strength and is considered unlikely to cause imbalance or joint strain during 
walking. However, if the patient reports discomfort related to wearing the device, or if the principal investigator 
determines that its use may cause imbalance or joint strain during gait, the use of the device will be discontinued 
immediately. 
Through participation in this study, subjects will receive information about their physical functions, including gait 
and balance abilities. The accumulated data during the study will be utilized to improve and enhance the 
rehabilitation device and to develop gait rehabilitation services. Additionally, the data may be used in research 
related to disease treatment and prognosis, contributing to advancements in medicine and improvements in the 
quality of clinical care. Therefore, the potential benefits of this study are expected to outweigh the possible risks. 
 
6. Number of target audience and basis for calculation 
This study will be conducted on all patients visiting Yongin Severance Hospital who consent to participate and 
meet the inclusion criteria. The target recruitment rate is three participants per month among the hospital’s visitors. 
Considering the dropout rate and clinical circumstances, the target sample size has been set at 30 participants. 
 
7. Subject selection/exclusion criteria 

 
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(1) Inclusion Criteria 
1) 
Adults aged 19 or older 
2) 
Individuals who have undergone hip surgery due to hip osteoarthritis, avascular necrosis of the femoral 
head, or hip fracture 
3) 
Individuals who are at least two days post-hip surgery and are assessed to be medically stable 
4) 
Adequate cognitive ability (Korean Mini-Mental State Examination score ≥ 20) 
5) 
Able to sit at the edge of a bed without assistance and stand for 10 seconds regardless of support 
6) 
Functional Ambulatory Category (FAC) score of 1–3 
7) 
Participants who visited Yongin Severance Hospital, understood the study, and signed informed consent 
(2) Exclusion Criteria 
1) Individuals who, after undergoing hip surgery, present with exudate at the surgical site or report symptoms 
such as heat, redness, swelling, or severe pain at the affected area  
2) Contraindications for lower limb weight-bearing such as severe joint contractures, osteoporosis, or untreated 
fractures 
3) Progressive or unstable brain diseases or neurological paralysis from stroke 
4) Active infections or open wounds hindering device use 
5) Significant leg length discrepancies 
6) Severe deformities or contractures in the lower extremities 
7) History of poliomyelitis 
8) Inability to maintain seated or standing positions independently 
9) Severe spasticity (Modified Ashworth Scale grade ≥ 2) 
10) Bone metastases from cancer 
11) Severe internal diseases affecting device use (e.g., cardiovascular or respiratory diseases) 
12) Cognitive impairments preventing cooperation with device use 
13) Complaints of device-related side effects or potential rehabilitation discontinuation(e.g., severe obesity, 
skeletal deformity) 
14) Patients who are determined to be pregnant or potentially pregnant based on the medical interview 
15) Any other clinically significant findings deemed inappropriate by the investigator 
 
8. Information and management of clinical investigational drugs/medical devices 
Although this study does not conduct clinical trials, information and management methods for medical devices 
used in this study are as follows. 

 
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(1) Electrically Powered Orthopedic Exercise Device (Angel SUIT H10) 
1) Item name: Electrically Powered Orthopedic Exercise Device 
2) Classification number: A67020.02 
3) Packaging unit: 1 set 
4) Medical device grade: Grade 2 
5) Model name: Angel SUIT H10 
6) Manufacturer: Angel Robotics Co., Ltd. 
7) Permit number: Manufacturing Approval Number. 25-4093 
8) Appearance: 
9) Principle of operation, How to use and precautions - refer to the attached document 
 
(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 
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 

 
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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) Overview of study design 
This investigator-initiated exploratory study is a pilot study designed to evaluate the effectiveness and safety of 
the Electrically Powered Orthopedic Exercise Device by measuring and analyzing gait function and balance ability 
in patients who have undergone hip surgery under both non-wearing and wearing conditions.  
(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 
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.  

 
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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 & Control group 
This pilot study is designed as a single-group study and does 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 
education21, 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.22 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. 
 

 
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3) Manual Muscle Test (Medical Research Council Scale) – Hip Joint, Knee Joint, Ankle Joint 
The participant's muscle strength is assessed by group according to the criteria in the table below.23 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 assessed24, 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 activity25, 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) 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 

 
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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 Test is used to assess gait speed in patients undergoing rehabilitation for neurological and 
musculoskeletal disorders.26 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 test evaluates both gait speed and balance ability during walking.27 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 

 
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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 
Participants perform the 6-Minute Walk Test, which closely simulates daily walking activities,28 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) 

 
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 This test assesses both static and dynamic balance.29  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 parameters are collected and recorded. These parameters include total step count, cadence, 
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).30 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 : _________________________________________________________________________ 
 
 
 
 
 

 
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How much 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 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 
 

 
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(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 
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. Study 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 
 
 
 

 
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Primary Outcome 
Measure Assessment 
O 
 
 
O 
Secondary Outcome 
Measure Assessment 
O 
 
 
O 
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 Termination and Early Withdrawal 
(1) Termination and Early Discontinuation 
 1) If a participant withdraws consent before the study is completed 
- In cases of consent withdrawal, only the data collected up to the point of withdrawal will be used for the study. 
These data will be stored for three years after the study concludes and then destroyed. 
(2) Early Withdrawal : Participants will be withdrawn from the study under the following circumstances: 
1) The participant or their legal representative requests to discontinue participation. 
2) A serious adverse event occurs. 
3) The medical team determines that continuing participation poses significant medical risks to the participant. 
4) The participant undergoes surgery, takes medication, or uses other medical devices that could affect safety 
or efficacy evaluations. 
5) The participant fails to follow the investigator's instructions or does not comply with the terms outlined in 
the consent form, potentially affecting the validity of the evaluation. 
6) In cases where the participant is unable to continue the study after completing the pre-wearing gait 
evaluation and taking a 10-minute rest 
7) Other situations deemed problematic for study continuation by the clinical trial investigator. 
8) The participant develops a serious illness or experiences an accident during the study that could affect their 
functional abilities. 
- In cases of early withdrawal, the participant’s voluntary intent will be reconfirmed to ensure the decision does not 
stem from unintended early termination. If the participant still consents to the use of their data, the information 

 
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collected up to the point of withdrawal will be anonymized and used in the study. 
 
13. Safety Evaluation Criteria, Methods, and Reporting Procedures Including Adverse Events 
(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) 
 

 
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15. Measures for Protecting Personal Information and Maintaining the Confidentiality of Research 
Data 
(1) Protection of Participant Identity 
 When obtaining consent for the study, the researcher will explain the study to the participant and obtain consent 
in an independent consultation room within the outpatient rehabilitation department. 
All information collected from this study will be kept confidential and will not be disclosed to anyone other than 
the research team involved in the study. It will be used solely for research purposes. Sensitive personal information 
that can identify individuals will not be shared with institutions outside the hospital and will undergo a de-
identification process. De-identification will be conducted by assigning random numbers, ensuring that personal 
information is not exposed. Re-identification will only be allowed if necessary for the individual's treatment. Only 
the final analysis results will be disclosed to the medical device company, and data ownership will remain with the 
hospital. 
(2) Confidentiality of Research Data 
 Paper documents will be securely stored in locked cabinets to prevent unauthorized access. Electronic data will be 
saved on access-restricted computers managed by the responsible researcher. 
(3) Retention 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 Plan for Human-Derived Materials and Genetic Information 
 This study does not collect any human-derived materials or genetic information. 
 
17. Participant Recruitment Methods and Consent Procedures 
After obtaining approval from the Yongin Severance Hospital Institutional Review Board (IRB), participants will be 
recruited from patients visiting Yongin Severance Hospital who voluntarily decide to participate and provide consent. 
Interviews will be conducted in a private space to ensure confidentiality. Participants will be provided with an IRB-

 
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approved information sheet explaining the study, after which informed consent will be obtained. A thorough 
explanation of clinical trial participation will be provided to ensure participants understand the study. Consent will 
be collected in a non-coercive environment, emphasizing that participants can withdraw consent at any time of 
their own volition. Participants’ willingness to continue participation will be reconfirmed during study procedures, 
ensuring they are aware of their right to withdraw at any point. 
 
18. Protection Measures for Recruitment of Vulnerable Participants 
This study does not recruit vulnerable participants. 
 
19. Information on the principal investigator and participating researchers, location of research 
conduct, and research period 
(1) Research director 
name 
Affiliated organization 
Major 
spot 
phone call 
Nayoung 
Kim 
Yonsei University 
medical school 
Yongin Severance 
Hospital 
rehabilitation 
medicine 
Clinical 
Assistant 
Professor 
031-5189-8163 
Kny8452 @yuhs.ac 
 
(2) Test person in charge  
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 
spot 
phone call 
Nayoung 
Kim 
Yonsei University 
medical school 
Yongin Severance 
Hospital 
Rehabilitation 
medicine 
Clinical 
Assistant 
Professor 
031-5189-8163 
Kny8452 @yuhs.ac 
Junyoung 
Yonsei University 
Orthopedic 
Clinical 
031-5189-8451  

 
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Park 
medical school 
Yongin Severance 
Hospital 
Surgery 
Assistant 
Professor 
JJUNYON@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 
spot 
phone call 
Hwi-woo 
Yang 
Yonsei University Industry-Academic 
Cooperation Foundation 
Researcher 
010-7360-4439 
Rehab5@yuhs.ac 
 
20. Location and duration of research 
(1) Location of research 
Organization name 
location 
phone call 
Yonsei University College 
of Medicine 
Yongin Severance 
Hospital 
363 Dongbaekjukjeon-daero, 
Giheung-gu, Yongin-si, Gyeonggi-do 
( Middle East) 
031-5189-8891 
(2) Period 
12 months after IRB approval (e.g. March 2025 – February 2026) 
 
21. Data safety monitoring plan 
The safety inspector ( principal researcher ) monitors the overall research progress at monthly intervals, including 
the status of the research, whether the registration subjects are suitable for the selection criteria, the appropriateness 

 
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of the consent acquisition procedure, whether violations/deviations from the research plan have occurred, and 
whether the subjects have had adverse reactions. We aim to ensure the integrity of the data. 
22. Research execution plan (schedule) 
Detailed development 
details 
Detailed promotion schedule (months ) 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
1 1 1 2 
Research plan and IRB 
approval 
█ 
 
 
 
 
 
 
 
 
 
 
 
Recruitment of subjects 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
 
Conduct of research 
procedures and follow-
up period 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
 
 
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