Study to Verify Effectiveness and Safety of At-home Gait Rehabilitation Using Wearable Exoskeletal Robot to Improve Gait in Stroke Patients, Investigator Initiated, Single Center, Single Group Trial
Phase: PHASE4
Conditions: Stroke, Gait, Spastic, Gait, Hemiplegic
Sponsor: Yonsei University

 
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Prospective Clinical Study Protocol 
- Study to verify effectiveness and safety of at-home gait rehabilitation using 
wearable exoskeletal robot to improve gait in stroke patients, Investigator 
Initiated, Single center, Single group trial - 
 
 
2024.08.05 
 
 
 
 
 
 
 
[Severance Hospital] 
 

 
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Prospective Clinical Study Protocol 
 
1. Title, stage, protocol identification number, revision history, etc. 
- Title: Study to verify effectiveness and safety of at-home gait rehabilitation using wearable exoskeletal robot to 
improve gait in stroke patients, Investigator Initiated, Single center, Single group trial 
- Stage: phase 4 
 
 
2. Summary of study plan 
Study objective 
To evaluate the feasibility of a home-based robotic-assisted gait rehabilitation 
service using wearable exoskeletal robot for stroke patients 
Study design overview 
Investigator-initiated exploratory clinical study 
4 weeks, pilot study  
Drugs/medical devices for 
clinical trials 
Wearable exoskeletal robot 
Target number of subjects 
and calculation basis 
Sixteen patients diagnosed with stroke 
This study aims to provide robotic-assisted gait training using wearable 
exoskeletal robot either at home or in nearby indoor spaces. The target number 
of participants was set based on clinical conditions. 
 
Rationale: The target number of participants was determined to be 16, considering 
a recruitment goal of two participants per month from among the outpatients at 
Yongin Severance Hospital, while accounting for dropout rates and clinical 
conditions. 
Inclusion 
and 
exclusion 
criteria 
1. Inclusion criteria 
1) adults aged 19 to 79 years (based on the age on their national ID at the time 
of consent) 
2) individuals diagnosed with cerebral infarction or intracerebral hemorrhage 
confirmed by MRI or CT. 
3) patients who have passed at least one month since stroke diagnosis. 
4) individuals exhibiting spastic hemiplegic gait patterns due to stroke. 
5) patients with a Functional Ambulatory Category score of less than 4. 
6) individuals who can sit on the edge of a bed without assistance and stand for 

 
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10 seconds with or without assistance. 
7) individuals with sufficient cognitive ability to follow simple instructions and 
understand the study's content and purpose (Mini-Mental State Examination score 
>= 20) 
 
2. Exclusion criteria 
1) individuals with severe joint contractures or osteoporosis, or untreated 
fractures that contraindicate weight-bearing on the lower limbs. 
2) individuals with skin conditions or open wounds that prevent device usage. 
3) individuals with significant differences in leg length. 
4) individuals with severe deformities or joint contractures in the lower limbs. 
5) individuals at high risk of fractures due to conditions like osteoporosis. 
6) individuals unable to maintain a sitting or standing position independently. 
7) individuals with severe lower limb spasticity (Modified Ashworth Scale grade 
2 or higher). 
8) individuals with severe cognitive impairment (Mini-Mental State Examination 
score < 20), delirium, or severe language impairment that hinders cooperation 
with wearable exoskeletal robot gait training. 
9) individuals unable to maintain prolonged standing or walking due to 
conditions like orthostatic hypotension or cardiopulmonary impairment. 
10) individuals with conditions affecting gait, such as peripheral neuropathy, 
Parkinsonism, or those with alcohol dependence or severe diabetes. 
11) pregnant women or those who could become pregnant. 
12) individuals participating in other clinical trials. 
13) individuals at high risk of falls or bleeding due to conditions like 
coagulopathies. 
14) individuals shorter than 140 cm, taller than 190 cm, or weighing over 80 kg. 
15) individuals with other clinical findings deemed inappropriate for the study 
by the principal investigator or study coordinator. 
Study Methods 
After obtaining informed consent, a screening test is conducted. The screening 
test includes a review of the participant's baseline symptoms and signs, medical 
history, and medication usage, followed by a physical examination and assessment 
of gait status, including the use of assistive devices and gait patterns. Participants 
who pass the screening test undergo an initial assessment within seven days. 

 
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The initial assessment includes physical function tests such as the 10-meter walk 
test, the Timed Up and Go (TUG) test, and the Berg Balance Scale, along with 
quality of life and Beck Depression Inventory assessments. Participants who 
complete the initial assessment begin robotic-assisted gait training within two 
days. 
 
The training is conducted using a wearable exoskeletal robot for gait training at 
home or in nearby indoor spaces. The training lasts for four weeks, with sessions 
held 2-3 times per week, totaling 10 sessions, each lasting 30 minutes. 
 
After four weeks, the robotic-assisted gait training concludes, and within two 
days, an endpoint assessment identical to the initial assessment is performed. 
Satisfaction with the wearable exoskeletal robot is also evaluated. 
 
Any device malfunctions are addressed and documented. The usage and 
satisfaction levels of the wearable exoskeletal robot are analyzed, and pre- and 
post-training assessment metrics are compared. 
Evaluation variable 
1. Primary outcome measure 
- Walking speed in the 10-meter walk test 
2. Secondary outcome measures 
- body composition analysis results 
- spatiotemporal parameters of gait 
- Timed Up and Go Test (TUGT) 
- Berg Balance Scale (BBS) 
- Satisfaction survey related to the use of the wearable exoskeletal robot based 
on the 12-item, 5-point K-QUEST scale 
Data analysis and statistical 
methods 
1) Primary and secondary outcome measures 
As a preliminary study exploring the efficacy and safety of home-based robotic-
assisted gait training, the primary outcome measure is the walking speed in the 
10-meter walk test before and after the intervention. The efficacy of the 
intervention will be evaluated by comparing pre- and post-intervention results 
using the Wilcoxon signed-rank test, with a p-value less than 0.05 indicating a 
significant difference due to the intervention. 

 
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Secondary outcome measures include quality of life scale, depression scale, body 
composition results, spatiotemporal gait parameters, Timed Up and Go Test, and 
Berg Balance Scale. These will also be compared pre- and post-intervention using 
the Wilcoxon signed-rank test, with statistical significance set at a p-value less 
than 0.05. 
 
2. Satisfaction evaluation 
Satisfaction with the home-based robotic-assisted gait training will be analyzed 
using descriptive statistics to determine the mean, standard deviation, minimum, 
and maximum values for each item. Items with a mean score of 4 or higher will 
be interpreted as positive, while items with a mean score of 2 or lower will be 
interpreted as negative. 
 
 
3. Study background and theoretical basis 
 Out of the 2.6 million registered disabled individuals in Korea, 1.45 million are registered with physical and brain 
disabilities, accounting for 55% of the total registered disabilities (Source: Statistics Korea, 2020). Various causes 
such as stroke, cerebral palsy, spinal cord injury, and muscular dystrophy lead to functional impairments in the 
upper and lower limbs. According to a 10-year follow-up study on long-term functional levels in stroke rehabilitation, 
48.3% of patients showed moderate to severe motor function decline at 6 months post-stroke, and 43.6% at 12 
months, indicating a high demand for improving lower limb function and gait disabilities. Gait plays a crucial role 
in healthy skeletal and muscular development, improving cardiopulmonary function,1-3 and performing daily 
activities, making the acquisition of walking ability a primary goal in rehabilitation therapy. 
Various methods for gait rehabilitation training have been proposed,4 with robotic-assisted gait training recently 
gaining attention. Continuous and repetitive training is essential for functional recovery following central nervous 
system injuries,5,6 as it induces and enhances neuroplasticity. Robotic-assisted gait training facilitates accurate and 
repetitive walking patterns close to normal gait, overcoming discrepancies due to the therapist's experience, 
knowledge, and physical capabilities. Reports have shown that robotic-assisted gait training improves lower limb 
strength, gait and balance abilities, reduces depression, and enhances quality of life.7 Various forms of gait-assistive 
robots are being attempted in clinical settings. Wearable gait-assistive robots,5 compared to treadmill-based robots, 
offer precise and active training similar to actual walking, maximizing training effects. They are relatively compact, 
easily portable, and adjustable to individual patient characteristics. 

 
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The COVID-19 pandemic has increased the demand for healthcare services at home as well as within medical 
institutions. Despite significant advancements in rehabilitation robots due to developments in sensors, materials, 
near-field communication, and mobile applications, their use has been limited to medical institutions. This study 
aims to explore the feasibility of providing a home-based gait rehabilitation service using a wearable exoskeletal 
robot. 
 
 
4. Purpose of the study 
Through pre- and post-intervention assessments, the study aims to determine the effectiveness of home-visit 
rehabilitation gait training using a wearable exoskeletal robot, conducted by a rehabilitation therapist under a 
doctor's diagnosis and prescription. This intervention consists of 10 sessions over four weeks, aiming to improve 
the gait function of stroke patients. Additionally, the study will evaluate the effectiveness and safety of home-based 
rehabilitation services by assessing patient satisfaction with the robotic-assisted gait training and conducting 
physical examinations post-intervention. 
 
 
5. Risk/benefit analysis 
The study will use the Timed Up and Go Test (TUGT) to assess gait ability. This test is widely used in clinical 
settings and has a very low medical risk. To minimize the risk of falls during the test, participants will undergo 
sufficient practice under the supervision of the examiner before conducting the test in an environment equipped 
with safety bars. 
Participants in this study will receive information about their muscle mass, gait, and balance abilities, and will 
benefit from systematic robotic-assisted gait training at home. The accumulated data during the study will be used 
to improve and enhance gait rehabilitation devices and to develop home-based services. Additionally, this data will 
contribute to research related to disease treatment and prognosis, thereby advancing medical knowledge and 
improving the quality of care. Therefore, the benefits gained from this study are expected to outweigh the potential 
risks. 
 
 

 
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6. Target number of subjects and calculation basis 
 This study will be conducted on all patients visiting Yongin Severance Hospital who consent to participate and 
meet the selection criteria. The goal is to recruit two participants per month from the hospital's outpatients, with a 
target number of 10 participants, considering dropout rates and clinical conditions. 
 
 
7. Subject Inclusion/exclusion criteria 
1) Inclusion criteria 
(1) adults aged 19 to 79 years (based on the age on their national ID at the time of consent) 
(2) individuals diagnosed with cerebral infarction or intracerebral hemorrhage confirmed by MRI or CT. 
(3) patients who have passed at least one month since stroke diagnosis. 
(4) individuals exhibiting spastic hemiplegic gait patterns due to stroke. 
(5) patients with a Functional Ambulatory Category score of less than 4. 
(6) individuals who can sit on the edge of a bed without assistance and stand for 10 seconds with or without 
assistance. 
(7) individuals with sufficient cognitive ability to follow simple instructions and understand the study's content and 
purpose (Mini-Mental State Examination score >= 20) 
 
2) Exclusion criteria 
(1) individuals with severe joint contractures or osteoporosis, or untreated fractures that contraindicate weight-
bearing on the lower limbs. 
(2) individuals with skin conditions or open wounds that prevent device usage. 
(3) individuals with significant differences in leg length. 
(4) individuals with severe deformities or joint contractures in the lower limbs. 
(5) individuals at high risk of fractures due to conditions like osteoporosis. 
(6) individuals unable to maintain a sitting or standing position independently. 
(7) individuals with severe lower limb spasticity (Modified Ashworth Scale grade 2 or higher). 
(8) individuals with severe cognitive impairment (Mini-Mental State Examination score < 20), delirium, or severe 
language impairment that hinders cooperation with wearable exoskeletal robot gait training. 

 
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(9) individuals unable to maintain prolonged standing or walking due to conditions like orthostatic hypotension or 
cardiopulmonary impairment. 
(10) individuals with conditions affecting gait, such as peripheral neuropathy, Parkinsonism, or those with alcohol 
dependence or severe diabetes. 
(11) pregnant women or those who could become pregnant. 
(12) individuals participating in other clinical trials. 
(13) individuals at high risk of falls or bleeding due to conditions like coagulopathies. 
(14) individuals shorter than 140 cm, taller than 190 cm, or weighing over 80 kg. 
(15) individuals with other clinical findings deemed inappropriate for the study by the principal investigator or study 
coordinator. 
 
 
8. Information and management of clinical investigational drugs/medical devices 
 This study does not involve clinical trials; however, the following information and management methods pertain 
to the medical devices used in this study. 
 
1) Wearable exoskeletal robot 
(1) Item name: Wearable exoskeletal robot  
(2) Classification number: A67080.01 
(3) Packaging unit: 1 set 
(4) Medical device class: Class III 
(5) Model name: M20-A-C3, M20-B-C3 
(6) Manufacturer: Angel Robotics Co., Ltd. 
(7) Approval number: No. 22-857 
(8) Appearance 
(9) Intended use: A robotic automation system used for muscle reconstruction and joint movement recovery 

 
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(10) Mechanism, usage, and precautions: Refer to the attached document 
 
2) Device management 
The wearable exoskeletal robot used in this study will be provided as one unit along with a robot transport cart 
and gait aid tools, managed as follows: 
(1) Security 
The medical device used in this study will be stored according to the specified storage environment conditions in 
a designated location (Spring County Jai Banquet Hall storage room) equipped with a locking mechanism. 
Cooperation has been obtained from the institution's responsible person for the use of this location and locking 
mechanism, and the medical device manager is responsible for security checks. (Refer to the attached document) 
(2) Infection control 
The medical device manager will conduct thorough disinfection procedures between sessions to minimize the risk 
of cross-infection between participants. Before using the equipment, the manager will supervise the personal 
hygiene of participants using hand sanitizers available in the indoor space where the gait training is conducted. 
(3) Device transport and retrieval 
The robotic-assisted orthopedic exercise device used in the study will be transported and retrieved using a robot 
transport cart between the banquet hall where the gait training is conducted and the storage room where the 
device is kept. These areas are connected spaces. 
 
 
9. Study design (test group·control group, allocation, blinding and flow chart, etc.) 
1) Study design overview 
This investigator-initiated exploratory study will be conducted over a period of four weeks. 
 
2) Experimental group 
This study will include a single test group with a total of 10 participants. The selection of participants and the 
entire treatment process using the wearable skeletal robot will be conducted according to the prescription and 
guidance of a specialist in rehabilitation medicine, under the supervision of two occupational therapists. Participants 
will receive robotic-assisted gait training twice a week for 30 minutes over four weeks, either at home or in nearby 

 
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indoor spaces such as a gym. 
 
3) Randomization and control group 
This preliminary study follows a single-group design without randomization or a control group. 
 
4) Flowchart 
 
 
 
10. Study Methods 
1) Screening methods 
 The screening evaluation will be conducted by a specialist in rehabilitation medicine in an independent space, such 
as a consultation room, at Yongin Severance Hospital. After providing a thorough explanation of the study to the 
participants and obtaining their consent, the following steps will be taken: 
(1) Vital signs 
- The examiner checks the participant's blood pressure, pulse, and temperature. 
(2) Physical examination 

 
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① Manual muscle testing (lower limbs) 
- The examiner evaluates the participant's lower limb manual muscle strength and joint range of motion according 
to the table below. The evaluation should be performed with the participant lying down or in a prone position, and 
the examiner can assist in changing positions if necessary. 
 
② Joint range of motion assessment (lower limbs)8 
- The examiner evaluates the participant's lower limb manual muscle strength and joint range of motion using the 
table below as a reference. The assessment should be performed with the participant in a lying down or prone 
position, and the examiner can assist with position changes if necessary. 
< Joint Range of Motion Assessment Guide > 
③ Spasticity assessment (Modified Ashworth Scale, MAS) (lower limbs)9 
- The examiner evaluates the degree of spasticity in the participant's three major lower limb joints (hip, knee, ankle) 
to determine the extent of functional or stability impairment. The evaluation criteria are as follows: 

 
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< Joint Spasticity Assessment Guide > 
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 Functional Ambulation Category (FAC)10 
- The examiner evaluates the participant's postural stability during walking by observing and recording their gait 
according to the criteria below. 
 
⑤ Mini-Mental State Examination (MMSE)11  
- A standardized tool used to evaluate cognitive function and screen for dementia in a short period. The examiner 
asks the participant questions from the questionnaire and records the score based on the responses. 

 
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(3) Bone Density Test12 
The examiner evaluates the patient's risk of osteoporosis based on their medical history and current medications. 
If the patient is suspected to be at risk for osteoporosis but has not undergone testing in the past two years, a 
bone density test using dual-energy X-ray absorptiometry (DEXA) will be performed. Osteoporosis is diagnosed 
when the bone density of the spine or hip has a T-score of less than -2.5.13 
(4) Pregnancy Test 
The examiner assesses the patient's potential for pregnancy through medical history and measurement of chorionic 
gonadotropin hormone levels in urine.14 
 
2) Pre- and post-intervention evaluation variables 
 Before and after the intervention program, the research team will conduct the following tests or surveys on 

 
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participants in an independent space at Yongin Severance Hospital. The final evaluation will be conducted within 2 
days after the intervention ends. 
(1) Primary outcome measure 
➀ 10MWT (10 meter walk test)  
A simple and effective clinical evaluation method used to measure the walking speed of participants, useful for 
assessing functional recovery and changes in gait ability. The measurement method involves timing how long it 
takes to walk 10 meters, then dividing 10 by the time taken to record the walking speed (m/s). 
 
(2) Secondary outcome measures 
➀ Health-related quality of life measurement (36-item Short Form Survey Instrument, SF-36) 
A self-reported survey consisting of 36 items used to assess participants' overall health-related quality of life. The 
evaluation tool measures satisfaction with overall health, with scores ranging from 0 to 100.15  
 
② Beck depression inventory (BDI)16 
An evaluation tool designed based on clinical depressive symptoms. It consists of 21 self-reported items where 

 
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patients check and record their scores in areas such as affective cognition and motivation. Scores range from 0 to 
63. 
 
③ Body composition analysis 
 This is a test performed to check the subject's limb muscle mass, and the test method is as follows. 
- Perform body composition analysis17 based on bioimpedance analysis. 
- To ensure accurate measurement, the test subject is instructed to empty his/her bladder before the test and not 
to consume caffeinated beverages, eat, drink, or perform strenuous exercise for one hour prior to the test. 
- To correct for muscle mass differences due to height, use the calculated value of limb muscle mass (Appendicular 
skeletal mass) divided by the square of the height. 

 
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④ Spatiotemporal parameters of walking 
Spatiotemporal parametric data of gait collected while the subject is performing a home-based activity wearing 
an insole gait analyzer, recording total steps, steps per minute, gait speed (km/h), distance walked (m), stride 
length (m), and swing phase rate (%). 
- Step count: The number of steps measured while walking. 
- Cadence: The number of steps taken per minute, with the unit being steps/min (spm). Normal values are ≥ 70 
steps/min for those under 65 years old and ≥ 60 steps/min for those 65 years and older. 
- Gait speed: The speed of walking, with the unit being km/h. Normal values are ≥ 2.0 km/h for those under 65 
years old and ≥ 1.5 km/h for those 65 years and older. 
- Distance: The total distance traveled while walking, measured in meters (m). 
- Stride length: The distance from the heel of one foot to the heel of the same foot in the next step. The distance 
is measured in meters (m), and it is normalized for height by dividing stride length by height. Normal values are ≥ 
0.5 m/height for those under 65 years old and ≥ 0.4 m/height for those 65 years and older. 
- Swing ratio: The percentage of the gait cycle that is in the swing phase, with the unit being %. Normal values are 
≥ 30% for those under 65 years old and ≥ 28% for those 65 years and older. 
⑤ Timed up and go test (TUG) 
The above test assesses walking speed along with balance ability during walking18, and this is performed as follows. 
- A 46 cm high armrest chair, a color cone is placed at a distance of 3 meters from the chair and the subject is 
instructed to sit on the chair. 
- In the preparation phase, the subject leans against the chair backrest and places his/her arms on the armrests, 
then stands up on the instruction "Start", walks 3 meters, turns around the color cone, returns to the starting point 
and sits down on the chair. 
 
 
⑥ Berg Balance Scale 
The following tests evaluate static and dynamic balance,19 and have been used in previous studies to assess 

 
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progress after robotic-assisted gait therapy.20 The examiner instructs the participant to perform the following 14 
tasks and evaluates them according to specific criteria. Scores range from 0 to 56. 
 
 
3) Satisfaction evaluation 
 Participants will complete a satisfaction survey for the home-based rehabilitation service using the wearable 
exoskeletal robot, based on the Korean version of the Quebec User Evaluation of Satisfaction with assistive 
Technology (K-QUEST 2.0).21 This survey consists of 12 items on a 5-point scale. Participants rate their satisfaction 
with the assistive device and related services as follows: 
1: Very dissatisfied, 2: Dissatisfied, 3: Neutral, 4: Satisfied, 5: Very satisfied 
Participants are instructed to provide reasons if they do not select "very satisfied" for any item. 
 
1 
2 
3 
4 
5 
Are you satisfied with the specifications (size, height, length, width) of the wearable exoskeletal 
robot?  
Reason: _________________________________________________________________________ 
 
 
 
 
 
How do you find the weight of the wearable exoskeletal robot?  
Reason: _________________________________________________________________________ 
 
 
 
 
 

 
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Is it convenient to adjust (fix and lock) parts of the wearable exoskeletal robot?  
Reason: _________________________________________________________________________ 
 
 
 
 
 
Do you think the wearable exoskeletal robot is safe and sturdy?  
Reason: _________________________________________________________________________ 
 
 
 
 
 
Are you satisfied with the durability (long-term usability) of the wearable exoskeletal robot? 
Reason: _________________________________________________________________________ 
 
 
 
 
 
Was the method of using the wearable exoskeletal robot convenient? 
Reason: _________________________________________________________________________ 
 
 
 
 
 
Do you think the wearable exoskeletal robot is comfortable to wear? 
Reason: _________________________________________________________________________ 
 
 
 
 
 
Are you satisfied with the effectiveness (purposeful use) of the wearable exoskeletal robot? 
Reason: _________________________________________________________________________ 
 
 
 
 
 
Are you satisfied with the service and delivery program (delivery process, time required) of the 
wearable exoskeletal robot? 
Reason: _________________________________________________________________________ 
 
 
 
 
 
Are you satisfied with the repair and maintenance service of the wearable exoskeletal robot? 
Reason: _________________________________________________________________________ 
 
 
 
 
 
Are you satisfied with the professional services (information, precautions) provided while using the 
wearable exoskeletal robot? 
Reason: _________________________________________________________________________ 
 
 
 
 
 
Are you satisfied with the after-sales service (continuous maintenance service) of the wearable 
exoskeletal robot? 
Reason: _________________________________________________________________________ 
 
 
 
 
 
- Please mark the three items participants consider most important among the 12 satisfaction items. 
 
O 표시 
1. Specifications 
 
2. Weight 
 
3. Convenience 
 
4. Safety 
 
5. Durability 
 
6. Usability 
 
7. Comfort 
 
8. Effectiveness 
 
9. Service delivery 
 

 
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10. Repair and maintenance services 
 
11. Professional services 
 
12. After-sales service 
 
 
4) Home-based robotic-assisted gait training 
 The participant's robotic-assisted gait training is conducted in collaboration with the research team (physical 
therapist or occupational therapist) under the prescription and guidance of a rehabilitation medicine specialist as 
follows. The gait training program begins within 2 days of the initial assessment and is conducted at home or in 
an indoor environment similar to the home setting. No transportation support, such as vehicles, is provided. 
(1) Warm-up exercises before wearing the robot 
 Participants perform stretching exercises for 5 minutes before wearing the wearable exoskeletal robot. 
(2) Application of the wearable exoskeletal robot 
 The wearable exoskeletal robot used in this study is a medical device that assists the hip and knee joints during 
gait training to achieve a near-normal walking trajectory. The evaluator applies this device to the participant and 
provides gait training on level ground. The robot can provide assistive torque during various walking phases, 
automatically detected through combined information from ground contact sensors, encoders (incremental and 
absolute) of the actuators, and inertial measurement unit sensors. According to the polynomial assistive joint torque 
profile by gait phase, flexion torque is generated in the hip and knee joints during the swing phase, and extension 
torque is generated in the hip and knee joints during the stance phase, aiding the participant's gait. The therapist 
aims to train the participant to walk in a pattern as close to normal as possible for the maximum duration. The gait 
training program consists of 10 sessions over 4 weeks, conducted 3 times a week for 30 minutes each session.22,23 
All training sessions are conducted under the supervision of two research team members (physical therapists or 
occupational therapists). If the participant cannot continue the 30-minute session due to muscle endurance decline 
or pain, the gait training is terminated, and the actual session duration and the reasons for early termination are 
recorded. 
(3) Recording adverse reactions and device malfunctions 
- The research team (physical therapists or occupational therapists) records the types and frequencies of safety 
incidents and reasons for device malfunctions that occur during the participant's gait training. 
- If adverse reactions such as pain occur, the type, severity, frequency, name of the adverse reaction, onset and 
resolution dates, characteristics, and causality are investigated and recorded. 
 

 
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5) Definition of analysis groups, missing data, and outlier management plan 
(1) Definition of analysis groups 
The analysis groups consist of all participants undergoing robotic-assisted gait training. The analysis includes their 
age, diagnosis, physical function assessments, and extracted gait parameter data. 
(2) Missing data and outlier management plan 
In cases of missing data due to study withdrawal or dropout, the Complete Case Analysis method is used, which 
analyzes only completely observed cases. Data from sessions with missing values are excluded from the analysis. 
Outliers identified using box plots and quartiles are also excluded from the analysis to maintain data integrity and 
enhance the study's accuracy and reliability. Information about the excluded participants is presented. 
 
6) Comparative analysis of pre- and post-intervention differences 
After the completion of the gait training program using the wearable exoskeletal robot, the evaluator performs 
a comparative analysis of the collected data from participants following the final assessment and satisfaction survey. 
 
 
11. Study procedures and evaluation 
Phase 
Screening 
/ Initial 
assessment 
Intervention 
Final 
assessment 
week 
0 
1 
2 
3 
4 
written consent 
O 
 
 
 
 
Inclusion/exclusion criteria 
O 
 
 
 
 
Demographic information and 
antecedent history 
O 
 
 
 
 
Primary outcome measure 
O 
 
 
 
O 
10MWT (10 meter walk test) 
Secondary outcome measures 
O 
 
 
 
O 

 
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Health-related quality of life 
measurement 
Beck depression inventory 
Body composition analysis 
Spatiotemporal parameters of 
walking 
Timed up and go test (TUG) 
Berg Balance Scale 
Satisfaction evaluation 
 
 
 
 
O 
Home-based robotic-assisted gait 
training 
 
O 
O 
O 
O 
 
 
12. Criteria for stopping and dropping out of the study 
 If a participant discontinues their participation in this clinical trial, only the information collected up to that point 
will be used in the study. The data will be stored for three years after the study ends and then destroyed. 
1) Termination and early suspension 
(1) Withdrawal of consent 
If the participant or their legal representative withdraws consent before the end of the study, only the information 
collected up to that point will be used. The data will be stored for three years after the study ends and then 
destroyed. 
(2) Occurrence of serious adverse events 
 
2) Dropout 
If the participant’s early discontinuation is not due to withdrawal, their willingness to continue providing 
information for the study will be reconfirmed. If they agree, the information collected up to the point of dropout 
will be anonymized and used in the study. 

 
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(1) The medical team determines that there is a serious medical necessity preventing the participant from continuing 
in the clinical study. 
(2) The participant uses concurrent surgery, medications, or other medical devices that may affect the safety and 
efficacy evaluations. 
(3) The participant does not comply with the investigator’s instructions or the terms of the consent form, affecting 
the evaluation of efficacy. 
(4) The participant's absence prevents continuous observation. 
(5) Other cases where the principal investigator determines there are issues in continuing the clinical trial. 
 
3) Handling of discontinuation and dropout 
(1) If a participant drops out, the reason for dropout and the clinical trial-related data collected up to the point of 
dropout will be recorded and stored. 
(2) If a participant is unable to visit during the study, their status must be confirmed, and the reason for their 
absence must be clearly documented. 
(3) Participants who drop out without valid reasons or justification will be included in the statistical analysis for 
efficacy and safety evaluation. 
 
 
13. Safety evaluation criteria, evaluation methods, and reporting methods, including adverse 
reactions 
1) Evaluation criteria 
To ensure the safety of study participants, the principal investigator will act as the safety monitor, conducting 
monitoring and evaluating safety. 
(1) Symptoms reported by participants or identified through physical examinations during or after the intervention 
in the control and experimental groups (e.g., musculoskeletal pain and skin lesions during gait training). 
(2) Physical examinations (e.g., musculoskeletal abnormalities and skin lesions such as erythema and edema at the 
site of the wearable exoskeletal robot application). 

 
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(3) Safety evaluation related to falls: 
- Number of falls 
- Severity of injuries caused by falls (e.g., bruises, fractures, other injuries) 
- Other 
 
2) Evaluation method 
(1) Perform statistical analysis to evaluate the severity and type of adverse reactions and the incidence rates of 
adverse reactions in the experimental and control groups, based on reports from participants or physical 
examinations. 
(2) Safety analysis will be conducted with a significance level of <0.05 (two-sided). 
 
3) Adverse event reporting 
(1) Reporting subjects: All participants in this clinical trial. 
(2) Adverse event evaluation criteria: 
- Evaluate the cause of adverse events according to the following criteria: 
- Device-related issues: Adverse events caused by device malfunction, breakdown, or damage despite following the 
intended use, method of use, and precautions specified by the manufacturer. 
- Procedural issues: Adverse events caused by the procedure itself when the device was used correctly and there 
were no issues with the patient's condition or underlying disease. 
- Patient-related issues: Adverse events caused by the patient's condition or underlying disease when the device 
was used correctly and the procedure was performed correctly. 
- Evaluation impossible: When the adverse event report does not match the actual product or multiple causes are 
involved, making it impossible to determine the cause. 
(3) Adverse event evaluation method 
- The clinical trial investigator will record symptoms, onset date, and resolution date of adverse reactions in an 
adverse reaction record form if an adverse reaction occurs during the trial. 
(4) Adverse event reporting method: 
- This content will be reported according to the regulations related to medical device clinical trials and the standard 
operating procedures (SOPs) specified by the clinical trial institution and the institution's IRB regulations. 

 
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I. Definition of terms 
- "Safety information" refers to data or information related to the safety and efficacy of 
approved, certified, or reported medical devices, including cases of adverse effects. 
- "Adverse effect information" refers to cases of adverse effects or potential adverse effects 
occurring domestically or internationally during the handling or use of medical devices. 
- "Side effect" refers to any unintended result, suspected to have occurred due to normal use 
of the medical device, including unintended desirable results. 
- "Adverse event" refers to undesirable outcomes among side effects, not necessarily having 
a causal relationship with the medical device. 
- "Serious adverse event" refers to an adverse event that meets any of the following criteria: 
a. Results in death or life-threatening adverse effects 
b. Requires hospitalization or prolongation of existing hospitalization 
c. Causes permanent or significant disability or incapacity 
d. Results in congenital anomalies or birth defects 
- "Unexpected adverse event" refers to an adverse event that differs in severity, specificity, or 
outcome from what is described in the approved, certified, or reported information of the 
medical device. 
 
II. Safety evaluation criteria 
Safety evaluation criteria refer to the standards for recording the severity of anticipated 
adverse effects and adverse reactions in case report forms. 
 
III. Safety evaluation methods 
The methods for safety evaluation include statistical analysis techniques and evaluation 
criteria for comparative assessment of the frequency of occurrence of adverse effects, 
abnormal device responses, and adverse reactions associated with clinical trial medical devices. 
 

 
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IV. Reporting adverse reactions 
- Serious adverse reactions at each institution must be reported to the clinical trial coordinator 
and monitoring staff via email within 48 hours of awareness. 
- The principal investigator must report serious adverse reactions to the institution's IRB 
according to IRB regulations and provide additional detailed reports as specified in the 
protocol. 
- In cases of death or life-threatening situations, the principal investigator must report to the 
head of the Food and Drug Administration within 7 days of becoming aware of the event. For 
other serious and unexpected adverse reactions, the report must be submitted within 15 days. 
 
 
4) Monitoring Plan for Participants Who Experience Adverse Events 
(1) This is a preliminary case study with a low risk level, requiring minimal invasive intervention. Therefore, weekly 
monitoring will be conducted under the supervision of the principal investigator. This monitoring will ensure data 
completeness by cross-checking supporting documents, case report forms (CRF), and protocols, and reviewing 
safety data of the study participants. 
(2) Participants who experience adverse events will be compensated according to the provisions of the compensation 
protocol in this study plan. Monitoring of the treatment progress will continue until the adverse reaction is resolved 
or until the participant's scheduled study completion. 
(3) For participants who experience adverse events and do not refuse follow-up, the progress of the adverse events 
will be observed through reported symptoms and physical examinations at scheduled study visits. 
 
5) As a preliminary case study with a low risk level requiring minimal invasive intervention, weekly monitoring will 
be conducted under the supervision of the principal investigator. This will ensure data completeness by cross-
checking supporting documents, CRF, and protocols, and reviewing the safety data of study participants. 
 
6) Participants in the study can decide to discontinue their participation at any time if they feel discomfort related 
to the study. The principal investigator or study coordinator will fully explain and confirm this when obtaining 
consent from participants. 

 
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7) In the event of any violations or deviations from the study, the situation and the researcher's actions and 
preventive measures will be promptly reported to the IRB in writing. Immediate treatment and observation will be 
provided if participants are injured or if new incidents occur during the evaluation, with a thorough investigation 
of the causes. Treatment will follow the hospital's standard procedures. These incidents will be reported in interim 
reports and included in the research paper. However, this study is considered to have a low likelihood of future 
adverse effects, and therefore no additional treatment costs have been budgeted. 
 
 
14. Data analysis and statistical considerations 
1) Primary and secondary outcome measures 
This study is a preliminary exploration of the efficacy and safety of home-based robotic-assisted gait training. The 
primary evaluation variable is the walking speed measured by the 10-meter walk test before and after robotic-
assisted gait rehabilitation. The pre- and post-intervention results will be compared using the Wilcoxon signed-rank 
test, with a p-value of less than 0.05 indicating a significant difference due to the intervention. 
 
Secondary evaluation variables include quality of life scale, depression scale, body composition results, 
spatiotemporal gait parameters, Timed Up and Go test, and Berg Balance Scale. These will also be compared pre- 
and post-intervention using the Wilcoxon signed-rank test, with statistical significance set at a p-value of less than 
0.05. 
The results of the satisfaction with home-based robotic-assisted gait training will be analyzed using descriptive 
statistics, identifying the mean, standard deviation, minimum, and maximum values for each item. Items with an 
average score of 4 or higher will be interpreted as positive, while items with an average score of 2 or lower will be 
interpreted as negative. 
 
2) Satisfaction evaluation: 
The satisfaction with the home-based gait rehabilitation service using the wearable exoskeletal robot will be 
analyzed using descriptive statistics, presenting the mean, standard deviation, median, minimum, and maximum 
values. 
 
 
15. Measures to protect personal information and maintain confidentiality of study data 

 
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1) Protection of the subject’s identity 
When seeking consent for study, the study is explained to the subject and consent is obtained in an independent 
space in the counseling room within the outpatient department of the Rehabilitation Medicine Department. 
All information collected from this study must be kept secret from anyone other than the researchers involved in 
the study and it is used for study purposes only. Sensitive personal information that can identify individuals will not 
be shared with organizations other than the hospital and will go through an anonymization process (deidentification). 
Anonymization is achieved by using the unique number of the insole-type gait analyzer issued to the subject, and 
data collected through the application will be stored in accordance with the medical device company's security 
policy and will be discarded after the end of the study, and will be de-identified before being forwarded to the 
medical device company. De-anonymization is limited to cases where it is necessary in relation to the individual's 
treatment. Only the final results of the analysis are disclosed to medical device companies and ownership of the 
data lies with the hospital.  
2) Confidentiality of study materials 
In the case of documentary data, it will be kept in a locked device to prevent it from being exposed to others, 
stored on a computer with restricted access, and managed by the researcher in charge. 
3) Preservation of records 
Study-related data are stored for 3 years in accordance with the Enforcement Rules of the Bioethics Act (Human 
subject researchers must keep records pursuant to Paragraph 1 for 3 years from the end of study), and among 
documents that have expired the retention period, subject related personal information shall be destroyed in 
accordance with Article 16 of the Enforcement Decree of the Personal Information Protection Act. However, if storage 
of the data is necessary for follow-up study, record accumulation, etc., the retention period must be extended after 
deliberation by the institutional committee. 
 
 
16. Management, storage, and disposal measures when collecting human materials, genetic 
information, etc. 
 No human specimens or genetic information are collected in this study. 
 
 

 
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17. Subject recruitment method and consent procedure 
After approval from the Yongin Severance Hospital IRB, among the visitors to Yongin Severance Hospital who 
decided and agreed to participate voluntarily in this study, interviews are conducted in an independent space, an 
explanatory statement approved by the IRB is provided, and consent forms are obtained. 
After providing a sufficient explanation regarding participation in the clinical trial, the consent form must be 
completed in a non-oppressive environment, and when writing the consent form, participants must be explained 
that consent can be withdrawn at any time, so that they participate in the clinical trial. In addition, the intention to 
participate in the study is confirmed during the conduct of the study test, so that consent can be withdrawn at any 
time at the person's discretion. 
 
 
18. Protection measures when recruiting vulnerable subjects 
 This study does not recruit vulnerable subjects.  
 
 
19. Information on the principal investigator and participating researchers, location of study conduct, 
and study period 
(1) Principal investigator 
Name 
Affiliated organization 
Major 
Job title 
Phone 
Na Young 
Kim 
Yonsei University 
College of Medicine 
Yongin Severance 
Hospital 
Rehabilitation 
medicine 
Assistant 
Professor 
031-5189-8163 
Kny8452 @yuhs.ac 
 
2) Test manager 
The test manager checks whether the test subject meets the selection criteria at the testing institution and manages 
the overall process of the experiment. 

 
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Name 
Affiliated organization 
Major 
Job title 
Phone 
Na Young 
Kim 
Yonsei University  
College of Medicine 
Yongin Severance 
Hospital 
rehabilitation 
medicine 
Assistant 
Professor 
031-5189-8163 
Kny8452 @yuhs.ac 
Seung Ick 
Choi 
Yonsei University  
College of Medicine 
Department 
of Integrative 
Medicine 
Integrated 
course 
graduate 
student 
010-8821-5297 
rehab1@yuhs.ac 
So Jeong 
Lim 
Yonsei University 
Industry-Academic 
Cooperation Foundation 
occupational 
therapy 
researcher 
010-2971-3773 
rehab2@yuhs.ac 
Hwi Woo 
Yang 
Yonsei University 
Industry-Academic 
Cooperation Foundation 
occupational 
therapy 
researcher 
010-7360-4439 
rehab5@yuhs.ac 
 
3) Medical device manager 
Name 
Affiliated organization 
Major 
Phone 
Seung Ick 
Choi 
Yonsei University  
College of Medicine 
Integrated 
course 
graduate 
student 
010-8821-5297 
rehab1@yuhs.ac 
 
 
20. Location and duration of study 
1) Location of study 
Organization name 
Location 
Phone 

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

 
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Detailed development 
items 
Detailed schedule (months) 
13 
14 
15 
16 
17 
18 
19 
20 
21 
22 
23 
24 
Subject Recruitment 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
 
Conduct of study 
procedures and follow-
up period 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
█ 
 
 
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