Gait Disorders, NeurologicNCT06410755
Home-based Rehabilitation Monitoring System With Wearable Devices and Self-Report Application
A study testing Integrated Wearable devices Monitoring sys-Assisted Home Rehabilitation Program in people with Gait Disorders, Neurologic, run by Yonsei University at 1 site in South Korea.
Trial summary
The goal of this clinical trial is to evaluate whether monitoring and providing feedback on the performance of a home-based exercise program using an integrated wearable monitoring system improves physical and cognitive function, and activity level in participants with stroke. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Gait Disorders, Neurologic
- What is being tested?
- Integrated Wearable devices Monitoring sys-Assisted Home Rehabilitation Program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 May 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults over 19 years of age
- Patients with a score of 2-3 on the Modified Rankin Scale who are ambulatory
- Patients who visited Yongin Severance Hospital who understood and agreed to the study and completed the informed consent form
Who cannot join
- Those with contraindications to lower extremity weight bearing such as severe lower extremity joint contractures, osteoporosis, or untreated fractures
- Progressive or unstable brain disease
- In addition to above, those who have clinically significant findings that are deemed inappropriate for this study in the medical judgment of the study director or person in charge
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Research on Evaluation of Home-based Rehabilitation Monitoring System With Wearable Devices and Self-Report Application
The goal of this clinical trial is to evaluate whether monitoring and providing feedback on the performance of a home-based exercise program using an integrated wearable monitoring system improves physical and cognitive function, and activity level in participants with stroke.
The integrated wearable monitoring system consists of an insole-type gait analyzer for objective gait assessment, a wrist-worn activity tracker for monitoring daily physical activity, and a self-report mobile application for delivering feedback and collecting participant-reported information.
Read more
This study also aims to assess participant satisfaction with the integrated wearable monitoring system during a 6-week home-based gait rehabilitation program.
The main questions this study aims to answer are:
- What effect does monitoring and providing feedback using an integrated wearable monitoring system have on physical and cognitive function, and activity level during a home-based gait rehabilitation program?
- How satisfied are participants with the use of the integrated wearable monitoring system?
Researchers will compare an intervention group that receives the integrated wearable monitoring system with a control group that performs the same home-based exercise program without wearable monitoring and feedback.
Participants in the intervention group will receive an insole-type gait analyzer, a wrist-worn activity tracker, and access to a mobile application, along with training in a prescribed home-based exercise program. During the 6-week intervention period, participants will wear the insole-type gait analyzer and the activity tracker while performing the home-based exercise program and will use the mobile application to receive feedback and self-report selected daily health-related information. After completion of the 6-week program, the investigators will conduct a satisfaction survey to evaluate participant experience with the integrated wearable monitoring system.
Read the detailed description
After obtaining written informed consent, a screening assessment is conducted to determine participant eligibility.
The screening assessment evaluates whether participants, regardless of assistive device use, are able to walk independently for more than 10 meters, based on an assessment of baseline symptoms and clinical signs. Eligible participants who pass the screening assessment are randomly assigned to either an intervention group or a control group.
Both groups undergo an initial assessment, during which baseline gait-related outcomes are measured. Participants are provided with information regarding their current gait status and general characteristics of normal gait and are instructed in a standardized home-based exercise program.
Participants assigned to the intervention group are provided with an integrated wearable monitoring system consisting of an insole-type gait analyzer, a wrist-worn activity tracker, and access to a mobile application. The researcher provides training on the proper use of the wearable devices and application and instructs participants to wear the devices as frequently and for as long as possible during daily activities and exercise sessions to enable continuous recording of gait patterns and physical activity. Based on the collected wearable data, the researcher provides individualized feedback to participants in the intervention group via telephone on a weekly basis.
Participants in the control group perform the same home-based exercise program but do not receive wearable monitoring devices or feedback related to their exercise performance.
At the completion of the 6-week home-based exercise program, an exit assessment identical to the initial assessment is conducted for both groups. In addition, participants in the intervention group complete a satisfaction survey to evaluate their experience with the integrated wearable monitoring system.
Throughout the intervention period, device-related issues, including malfunctions and usage interruptions, are documented. Usage patterns and satisfaction levels associated with the wearable monitoring system in the intervention group are analyzed, and pre- and post-intervention outcome measures are compared between the intervention and control groups.
- Conditions
- Gait Disorders, Neurologic
- Being tested
- Integrated Wearable devices Monitoring sys-Assisted Home Rehabilitation Program
- Keywords
- gait parameters, smart insole, home-based exercise, monitoring system, rehabilitation
- Medical subject headings
- Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Wearable devices Monitoring sys-Assisted Home Rehabilitation ProgramDevice
The researcher provides weekly feedback via telephone to participants in the intervention group based on exercise amount, walking level, and activity data collected through the integrated wearable monitoring system, which includes an insole-type gait analyzer, a wrist-worn activity tracker, and a self-report mobile application. Data collection stability is regularly monitored, and any abnormalities or device-related issues are addressed promptly and documented through telephone communication or in-person visits when necessary.
| Study group | Role | What they receive |
|---|---|---|
| Multi-modal Wearable Devices and Self-report Application group receiving monitoring and feedback | Experimental | The intervention group uses an integrated wearable monitoring system consisting of an insole-type gait analyzer, a wrist-worn activity tracker, and a self-report mobile application, and participants are instructed to use the wearable devices as frequently and for as long as possible during daily activities, particularly during outdoor walking. Researchers provide individualized feedback to participants once a week based on data collected from the wearable devices and the mobile application. After 6 weeks, usability and satisfaction with the integrated wearable monitoring system are evaluated. Receives: Device: Integrated Wearable devices Monitoring sys-Assisted Home Rehabilitation Program |
| Control group | No intervention | The control group is trained in the same exercise program as the intervention group, but doesn't use an integrated wearable monitoring system consisting of an insole-type gait analyzer, a wrist-worn activity tracker, and a self-report mobile application. |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute walking test results
While wearing the insole gait analyzer, the subject performs a 6-minute gait test, which is the test that most closely approximates everyday walking, and the examiner provides feedback on the gait by comparing the average parameter data extracted from the insole gait analyzer to a normal gait reference. The above evaluation is a test conducted to evaluate walking endurance, and the evaluation method is as follows.
- Install a colored cone with 30m on the floor and prepare a stopwatch.
- Instruct the subject to travel as many times as possible in a straight line of 30m for 6 minutes.
- Teach that they can rest and stop during the test and use only permitted phrases ('You're doing well', 'Keep going').
- The examiner records the total distance traveled and the pattern and occurrence time of the abnormal gait.
Measured: This test results will be assessed two times: baseline, exit (after 6 weeks)
Secondary outcomes (19)
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 analysis 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.
Measured: This test results will be assessed two times: baseline, exit (after 6 weeks)
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(steps/min), gait speed(km/h), distance walked(m), stride length(m), and swing phase rate(%).
Measured: This test results will be assessed two times: baseline, exit (after 6 weeks)
Korea-Mini Mental State Examination
A test that assesses the degree of overall cognitive impairment, taking into account a person's level of education, 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.
Measured: This test results will be assessed two times: baseline, exit (after 6 weeks)
Short form of Geriatric Depression Scale (Korean version of Short form of Geriatric Depression Scale)
This is a test used to assess the level of depression in older adults and able to assess quickly the level of depression in the elderly and identify risk. The examiner asks the subject questions according to the questionnaire below, checks items according to the answers, and scores them according to the evaluation method.
This consists of 15 items and is the most commonly used version due to its brevity and ease of use. It can typically be completed in 5 to 7 minutes.
Each item on the GDS is scored 0 or 1, depending on whether the symptom of depression is absent or present according to the patient's response. The total score is calculated by summing up the scores for each item. Generally, a score of 0 to 5 is considered normal, depending on the setting and clinical judgment. Scores of 5 or more suggest depression, with scores of 10 or higher almost always indicative of depression.
Measured: This test results will be assessed two times: baseline, exit (after 6 weeks)
Korean version of Sarcopenia Screening Questionnaire
Questionnaire that evaluates the decrease in muscle strength and functional performance along with a decrease in muscle mass and it is highly related to aging and chronic diseases. The evaluation method is conducted by having the examiner ask the subject about the following questionnaire, and the scores for the answers are recorded.
It consists of 5 questions, and each question is scored 0-2 points. The higher the score, the higher the risk of sarcopenia. If the score is 4 or higher, sarcopenia may be suspected.
Measured: This test results will be assessed two times: baseline, exit (after 6 weeks)
Functional Ambulation Category
Assessment of the subject's walking function. The examiner observes the subject's gait and records a score based on the criteria in the assessment sheet below.
Measured: This test results will be assessed two times: baseline, exit (after 6 weeks)
Korean version of the International Physical Activity Questionnaire (K-IPAQ)
Tests that assess various aspects of an individual's daily physical activity 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'.
Measured: This test results will be assessed two times: baseline, exit (after 6 weeks)
Grip Strength Test
A test that evaluates the subject's grip strength, and the evaluation method is as follows.
- The subject sits in the correct posture and bends the elbows to 90 degrees.
- Place the handle of the measuring device between the first and second joints of each finger and hold it tightly according to the examiner's instructions.
- Measure the left and right three times each and record the maximum value.
Measured: This test results will be assessed two times: baseline, exit (after 6 weeks)
Clinical Frailty Scale
Test to assess the health status and frailty of elderly and assesses the health and vulnerability of the elderly after the program ends.
The scale ranges from 1 to 9, with each level described through specific criteria that reflect the degree of fitness or frailty, a higher score means poorer health.
Measured: This test results will be assessed two times: baseline, exit (after 6 weeks)
European Quality of Life-5 Dimensions
It consists of items evaluating exercise ability, self-management, daily activities (work, study, housework, family or leisure activities), pain/discomfort, and anxiety/depression, and examiner evaluates according to the form below.
Participants will be asked to answer each question with 3 items, and a higher score means more health problems, minimum score is 5 and maximum score is 15.
Measured: This test results will be assessed two times: baseline, exit (after 6 weeks)
Mini-Nutritional Assessment
An assessment of nutritional status and risk of undernutrition or malnutrition using questionnaire to assess the nutritional status of a subject, and the examiner records a score based on the criteria in the questionnaire below.
Measured: This test results will be assessed two times: baseline, exit (after 6 weeks)
Assessment of activities of daily living and instrumental activities of daily living (ADL & I-ADL assessment)
This assessment uses a questionnaire that assesses the nutritional status of subjects to determine their nutritional status and whether they are undernourished or at risk of being undernourished, and the examiner records a score based on the criteria in the questionnaire below.
Measured: This test results will be assessed two times: baseline, exit (after 6 weeks)
Short Physical Performance Battery (SPPB)
This is a test that evaluates three areas to assess a subject's lower extremity physical functioning, and it measures and records scores in three areas: balance, getting up from a chair, and walking speed.
- Balance test: Line up feet in parallel and hold for 10 seconds. If possible, perform this test in a semi-upright position, then straighten feet and repeat 3 times.
- Chair stand-up test: Perform the stand-up test 5 times from a chair. The examiner measures the time and records the score according to the criteria below.
- Walking speed test: After having the subject walk 3m, the examiner measures the time and scores according to the criteria below.
Measured: This test results will be assessed two times: baseline, exit (after 6 weeks)
Timed up and go test (TUG)
The above test assesses walking speed along with balance ability during walking, 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.
Measured: This test results will be assessed two times: baseline, exit (after 6 weeks)
Berg Balance Scale
The above test assesses static and dynamic balance, in which the examiner instructs the subject to perform the 14 movements below and then scores them against a set of criteria.
Measured: This test results will be assessed two times: baseline, exit (after 6 weeks)
Cybex isokinetic strength evaluation
A test to measure lower extremity strength and power using the isokinetic exercise equipment CYBEX, and 5 repetitions of 60/60 degrees per second and 15 repetitions of 150/150 degrees per second are performed to measure Peak Torque (Nm), Total Work (J), Average power per repetition (W), and Fatigue Index (%) of the lower extremity muscles.
Measured: This test results will be assessed two times: baseline, exit (after 6 weeks)
Application survey response rate
Subjects complete the following five questionnaires before bed, based on the application usage method they were trained on by the examiner. Based on the subject's questionnaire records, the subject's weekly response rate is calculated as n out of 5 responses and n out of 7 days.
The subject conducts the following five surveys before going to bed based on how to use the application trained by the inspector. Based on the subject's questionnaire record, the subject's weekly response rate is calculated with n responses out of 5 and n responses out of 7 days.
The five surveys consist of Mood, Appetite, Sleep Quality and Duration, Activity Level, and Pain.
Measured: This test results will be assessed up to 6 weeks
K-QEUST-based wearable device satisfaction assessment
The subjects of the experimental group return the smart band to the inspector, and fill out a 12-item, 5-point smart band based on the Korean version of the assistance instrument satisfaction test (K-QUEST 2.0), and a satisfaction evaluation questionnaire for the application linked thereto. This questionnaire consists of 12 items to evaluate the satisfaction, and the satisfaction with the assistance instrument and the service used in this regard is expressed in 1-5 points below. If the rest of the items except for very satisfaction are filled out, instruct the subject to fill out the reason. The target group does not do the above. 1: Very unsatisfied. 2: Not satisfied 3: Usually 4: Very satisfied. 5: Very satisfied
Measured: This test result will be assessed once at the end of the 6-week intervention.
10m Walk Test
The 10-Meter Walk Test16 is used to assess gait speed in patients undergoing rehabilitation for neurological and Severance: H10_250409 musculoskeletal disorders. Participants wear an insole-type gait analyzer and walk a 10-meter straight path at a consistent pace while the time taken is measured to evaluate gait ability.
- A 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.
Measured: This test results will be assessed two times: baseline, exit (after 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start14 May 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (54)Papers the sponsor has linked to this study.
- Other trials for Gait Disorders, NeurologicStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a researcher-led, exploratory, randomized controlled clinical study conducted over 6 weeks. Participants are randomly assigned to either an intervention or a control group, which differ in exposure to the wearable device-based intervention. The integrated wearable monitoring system includes an insole-type gait analyzer, a wrist-worn activity tracker, and a self-report mobile application. Participants in the intervention group use the wearable system during daily activities, and weekly individualized feedback is provided via telephone based on collected data. Usability and satisfaction are assessed after the intervention. The control group performs the same home-based exercise program without wearable devices, mobile application access, or feedback.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Collaborators
- Korea Health Industry Development Institute
- Responsible party
- Principal investigator, Na Young Kim, Severance Hospital
- Investigators
- Na Young Kim, MD, PhD, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06410755
- Sponsor's protocol ID
- 9-2023-0194
- Status last verified
- Jul 2026
- First submitted
- 21 Apr 2024
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karvonen J, Vuorimaa T. Heart rate and exercise intensity during sports activities. Practical application. Sports Med. 1988 May;5(5):303-11. doi: 10.2165/00007256-198805050-00002.
PubMed 3387734Sindhu BS, Shechtman O, Tuckey L. Validity, reliability, and responsiveness of a digital version of the visual analog scale. J Hand Ther. 2011 Oct-Dec;24(4):356-63; quiz 364. doi: 10.1016/j.jht.2011.06.003. Epub 2011 Aug 6.
PubMed 21820864Hagstromer M, Oja P, Sjostrom M. The International Physical Activity Questionnaire (IPAQ): a study of concurrent and construct validity. Public Health Nutr. 2006 Sep;9(6):755-62. doi: 10.1079/phn2005898.
PubMed 16925881Wang TL, Wu HY, Wang WY, Chen CW, Chien WC, Chu CM, Wu YS. Assessment of Heart Rate Monitoring During Exercise With Smart Wristbands and a Heart Rhythm Patch: Validation and Comparison Study. JMIR Form Res. 2023 Dec 14;7:e52519. doi: 10.2196/52519.
PubMed 38096010Snyder NC, Willoughby CA, Smith BK. Accuracy of Garmin and Polar Smart Watches to Predict VO2max. Medicine & Science in Sports & Exercise 2017;49:761
Alsiddiky A, Awwad W, Bakarman K, Fouad H, Mahmoud NM. Magnetic resonance imaging evaluation of vertebral tumor prediction using hierarchical hidden Markov random field model on Internet of Medical Things (IOMT) platform. Measurement 2020;159:107772
Al-Makhadmeh Z, Tolba A. Utilizing IoT wearable medical device for heart disease prediction using higher order Boltzmann model: A classification approach. Measurement 2019;147:106815
Pinto S, Almeida F, Caldeira S, Martins JC. The Comfort app prototype: introducing a web-based application for monitoring comfort in palliative care. Int J Palliat Nurs. 2017 Sep 2;23(9):420-431. doi: 10.12968/ijpn.2017.23.9.420.
PubMed 28933997Larsen K, Akindele B, Head H, Evans R, Mehta P, Hlatky Q, Krause B, Chen S, King D. Developing a User-Centered Digital Clinical Decision Support App for Evidence-Based Medication Recommendations for Type 2 Diabetes Mellitus: Prototype User Testing and Validation Study. JMIR Hum Factors. 2022 Jan 18;9(1):e33470. doi: 10.2196/33470.
PubMed 34784293Suso-Ribera C, Castilla D, Zaragoza I, Ribera-Canudas MV, Botella C, Garcia-Palacios A. Validity, Reliability, Feasibility, and Usefulness of Pain Monitor: A Multidimensional Smartphone App for Daily Monitoring of Adults With Heterogenous Chronic Pain. Clin J Pain. 2018 Oct;34(10):900-908. doi: 10.1097/AJP.0000000000000618.
PubMed 29659375Yoshida Y, Patil SJ, Brownson RC, Boren SA, Kim M, Dobson R, Waki K, Greenwood DA, Torbjornsen A, Ramachandran A, Masi C, Fonseca VA, Simoes EJ. Using the RE-AIM framework to evaluate internal and external validity of mobile phone-based interventions in diabetes self-management education and support. J Am Med Inform Assoc. 2020 Jun 1;27(6):946-956. doi: 10.1093/jamia/ocaa041.
PubMed 32377676Jakob R, Harperink S, Rudolf AM, Fleisch E, Haug S, Mair JL, Salamanca-Sanabria A, Kowatsch T. Factors Influencing Adherence to mHealth Apps for Prevention or Management of Noncommunicable Diseases: Systematic Review. J Med Internet Res. 2022 May 25;24(5):e35371. doi: 10.2196/35371.
PubMed 35612886Collins DAJ, Harvey SB, Lavender I, Glozier N, Christensen H, Deady M. A Pilot Evaluation of a Smartphone Application for Workplace Depression. Int J Environ Res Public Health. 2020 Sep 16;17(18):6753. doi: 10.3390/ijerph17186753.
PubMed 32947994Estrin D, Sim I. Health care delivery. Open mHealth architecture: an engine for health care innovation. Science. 2010 Nov 5;330(6005):759-60. doi: 10.1126/science.1196187. No abstract available.
PubMed 21051617Kim AL. Effects of structured arm exercise on arteriovenous fistula stenosis in hemodialysis patient. Journal of Korean Biological Nursing Science 2012;14:300-307
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Evaluation of Home-based Rehabilitation Monitoring System With Wearable Devices and Self-Report Application
- ClinicalTrials.gov ID
- NCT06410755
- Acronym / sponsor ID
- 9-2023-0194
- Conditions
- Gait Disorders, Neurologic
- Keywords
- gait parameters, smart insole, home-based exercise, monitoring system, rehabilitation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Collaborators
- Korea Health Industry Development Institute
- Study start
- 14 May 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate whether monitoring and providing feedback on the performance of a home-based exercise program using an integrated wearable monitoring system improves physical and cognitive function, and activity level in participants with stroke.
The integrated wearable monitoring system consists of an insole-type gait analyzer for objective gait assessment, a wrist-worn activity tracker for monitoring daily physical activity, and a self-report mobile application for delivering feedback and collecting participant-reported information.
This study also aims to assess participant satisfaction with the integrated wearable monitoring system during a 6-week home-based gait rehabilitation program.
The main questions this study aims to answer are:
- What effect does monitoring and providing feedback using an integrated wearable monitoring system have on physical and cognitive function, and activity level during a home-based gait rehabilitation program?
- How satisfied are participants with the use of the integrated wearable monitoring system?
Researchers will compare an intervention group that receives the integrated wearable monitoring system with a control group that performs the same home-based exercise program without wearable monitoring and feedback.
Participants in the intervention group will receive an insole-type gait analyzer, a wrist-worn activity tracker, and access to a mobile application, along with training in a prescribed home-based exercise program. During the 6-week intervention period, participants will wear the insole-type gait analyzer and the activity tracker while performing the home-based exercise program and will use the mobile application to receive feedback and self-report selected daily health-related information. After completion of the 6-week program, the investigators will conduct a satisfaction survey to evaluate participant experience with the integrated wearable monitoring system.
Detailed description
After obtaining written informed consent, a screening assessment is conducted to determine participant eligibility.
The screening assessment evaluates whether participants, regardless of assistive device use, are able to walk independently for more than 10 meters, based on an assessment of baseline symptoms and clinical signs. Eligible participants who pass the screening assessment are randomly assigned to either an intervention group or a control group.
Both groups undergo an initial assessment, during which baseline gait-related outcomes are measured. Participants are provided with information regarding their current gait status and general characteristics of normal gait and are instructed in a standardized home-based exercise program.
Participants assigned to the intervention group are provided with an integrated wearable monitoring system consisting of an insole-type gait analyzer, a wrist-worn activity tracker, and access to a mobile application. The researcher provides training on the proper use of the wearable devices and application and instructs participants to wear the devices as frequently and for as long as possible during daily activities and exercise sessions to enable continuous recording of gait patterns and physical activity. Based on the collected wearable data, the researcher provides individualized feedback to participants in the intervention group via telephone on a weekly basis.
Participants in the control group perform the same home-based exercise program but do not receive wearable monitoring devices or feedback related to their exercise performance.
At the completion of the 6-week home-based exercise program, an exit assessment identical to the initial assessment is conducted for both groups. In addition, participants in the intervention group complete a satisfaction survey to evaluate their experience with the integrated wearable monitoring system.
Throughout the intervention period, device-related issues, including malfunctions and usage interruptions, are documented. Usage patterns and satisfaction levels associated with the wearable monitoring system in the intervention group are analyzed, and pre- and post-intervention outcome measures are compared between the intervention and control groups.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study is a researcher-led, exploratory, randomized controlled clinical study conducted over 6 weeks. Participants are randomly assigned to either an intervention or a control group, which differ in exposure to the wearable device-based intervention. The integrated wearable monitoring system includes an insole-type gait analyzer, a wrist-worn activity tracker, and a self-report mobile application. Participants in the intervention group use the wearable system during daily activities, and weekly individualized feedback is provided via telephone based on collected data. Usability and satisfaction are assessed after the intervention. The control group performs the same home-based exercise program without wearable devices, mobile application access, or feedback.
| Arm | Type | Receives |
|---|---|---|
| Multi-modal Wearable Devices and Self-report Application group receiving monitoring and feedback | Experimental | Device: Integrated Wearable devices Monitoring sys-Assisted Home Rehabilitation ProgramThe intervention group uses an integrated wearable monitoring system consisting of an insole-type gait analyzer, a wrist-worn activity tracker, and a self-report mobile application, and participants are instructed to use the wearable devices as frequently and for as long as possible during daily activities, particularly during outdoor walking. Researchers provide individualized feedback to participants once a week based on data collected from the wearable devices and the mobile application. After 6 weeks, usability and satisfaction with the integrated wearable monitoring system are evaluated. |
| Control group | No intervention | –The control group is trained in the same exercise program as the intervention group, but doesn't use an integrated wearable monitoring system consisting of an insole-type gait analyzer, a wrist-worn activity tracker, and a self-report mobile application. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults over 19 years of age
- Patients with a score of 2-3 on the Modified Rankin Scale who are ambulatory
- Patients who visited Yongin Severance Hospital who understood and agreed to the study and completed the informed consent form
Key exclusion criteria (3 listed)
- Those with contraindications to lower extremity weight bearing such as severe lower extremity joint contractures, osteoporosis, or untreated fractures
- Progressive or unstable brain disease
- In addition to above, those who have clinically significant findings that are deemed inappropriate for this study in the medical judgment of the study director or person in charge
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated Wearable devices Monitoring sys-Assisted Home Rehabilitation ProgramThe researcher provides weekly feedback via telephone to participants in the intervention group based on exercise amount, walking level, and activity data collected through the integrated wearable monitoring system, which includes an insole-type gait analyzer, a wrist-worn activity tracker, and a self-report mobile application. Data collection stability is regularly monitored, and any abnormalities or device-related issues are addressed promptly and documented through telephone communication or in-person visits when necessary. | Device | Multi-modal Wearable Devices and Self-report Application group receiving monitoring and feedback |
Primary outcome
6-minute walking test results
Time frame: This test results will be assessed two times: baseline, exit (after 6 weeks)
While wearing the insole gait analyzer, the subject performs a 6-minute gait test, which is the test that most closely approximates everyday walking, and the examiner provides feedback on the gait by comparing the average parameter data extracted from the insole gait analyzer to a normal gait reference. The above evaluation is a test conducted to evaluate walking endurance, and the evaluation method is as follows. 1. Install a colored cone with 30m on the floor and prepare a stopwatch. 2. Instruct the subject to travel as many times as possible in a straight line of 30m for 6 minutes. 3. Teach that they can rest and stop during the test and use only permitted phrases ('You're doing well', 'Keep going'). 4. The examiner records the total distance traveled and the pattern and occurrence time of the abnormal gait.
19 secondary outcomes
body composition analysis
Time frame: This test results will be assessed two times: baseline, exit (after 6 weeks)
Spatiotemporal parameters of walking
Time frame: This test results will be assessed two times: baseline, exit (after 6 weeks)
Korea-Mini Mental State Examination
Time frame: This test results will be assessed two times: baseline, exit (after 6 weeks)
Short form of Geriatric Depression Scale (Korean version of Short form of Geriatric Depression Scale)
Time frame: This test results will be assessed two times: baseline, exit (after 6 weeks)
Korean version of Sarcopenia Screening Questionnaire
Time frame: This test results will be assessed two times: baseline, exit (after 6 weeks)
Functional Ambulation Category
Time frame: This test results will be assessed two times: baseline, exit (after 6 weeks)
Korean version of the International Physical Activity Questionnaire (K-IPAQ)
Time frame: This test results will be assessed two times: baseline, exit (after 6 weeks)
Grip Strength Test
Time frame: This test results will be assessed two times: baseline, exit (after 6 weeks)
Clinical Frailty Scale
Time frame: This test results will be assessed two times: baseline, exit (after 6 weeks)
European Quality of Life-5 Dimensions
Time frame: This test results will be assessed two times: baseline, exit (after 6 weeks)
Mini-Nutritional Assessment
Time frame: This test results will be assessed two times: baseline, exit (after 6 weeks)
Assessment of activities of daily living and instrumental activities of daily living (ADL & I-ADL assessment)
Time frame: This test results will be assessed two times: baseline, exit (after 6 weeks)
Short Physical Performance Battery (SPPB)
Time frame: This test results will be assessed two times: baseline, exit (after 6 weeks)
Timed up and go test (TUG)
Time frame: This test results will be assessed two times: baseline, exit (after 6 weeks)
Berg Balance Scale
Time frame: This test results will be assessed two times: baseline, exit (after 6 weeks)
Cybex isokinetic strength evaluation
Time frame: This test results will be assessed two times: baseline, exit (after 6 weeks)
Application survey response rate
Time frame: This test results will be assessed up to 6 weeks
K-QEUST-based wearable device satisfaction assessment
Time frame: This test result will be assessed once at the end of the 6-week intervention.
10m Walk Test
Time frame: This test results will be assessed two times: baseline, exit (after 6 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Results publication: PubMed 3387734Karvonen J, Vuorimaa T. Heart rate and exercise intensity during sports activities. Practical application. Sports Med. 1988 May;5(5):303-11. doi: 10.2165/00007256-198805050-00002.
- Results publication: PubMed 21820864Sindhu BS, Shechtman O, Tuckey L. Validity, reliability, and responsiveness of a digital version of the visual analog scale. J Hand Ther. 2011 Oct-Dec;24(4):356-63; quiz 364. doi: 10.1016/j.jht.2011.06.003. Epub 2011 Aug 6.
- Results publication: PubMed 16925881Hagstromer M, Oja P, Sjostrom M. The International Physical Activity Questionnaire (IPAQ): a study of concurrent and construct validity. Public Health Nutr. 2006 Sep;9(6):755-62. doi: 10.1079/phn2005898.
- Results publication: PubMed 38096010Wang TL, Wu HY, Wang WY, Chen CW, Chien WC, Chu CM, Wu YS. Assessment of Heart Rate Monitoring During Exercise With Smart Wristbands and a Heart Rhythm Patch: Validation and Comparison Study. JMIR Form Res. 2023 Dec 14;7:e52519. doi: 10.2196/52519.
- Results publicationSnyder NC, Willoughby CA, Smith BK. Accuracy of Garmin and Polar Smart Watches to Predict VO2max. Medicine & Science in Sports & Exercise 2017;49:761
- Results publicationAlsiddiky A, Awwad W, Bakarman K, Fouad H, Mahmoud NM. Magnetic resonance imaging evaluation of vertebral tumor prediction using hierarchical hidden Markov random field model on Internet of Medical Things (IOMT) platform. Measurement 2020;159:107772
- Results publicationAl-Makhadmeh Z, Tolba A. Utilizing IoT wearable medical device for heart disease prediction using higher order Boltzmann model: A classification approach. Measurement 2019;147:106815
- Results publication: PubMed 28933997Pinto S, Almeida F, Caldeira S, Martins JC. The Comfort app prototype: introducing a web-based application for monitoring comfort in palliative care. Int J Palliat Nurs. 2017 Sep 2;23(9):420-431. doi: 10.12968/ijpn.2017.23.9.420.
- Results publication: PubMed 34784293Larsen K, Akindele B, Head H, Evans R, Mehta P, Hlatky Q, Krause B, Chen S, King D. Developing a User-Centered Digital Clinical Decision Support App for Evidence-Based Medication Recommendations for Type 2 Diabetes Mellitus: Prototype User Testing and Validation Study. JMIR Hum Factors. 2022 Jan 18;9(1):e33470. doi: 10.2196/33470.
- Results publication: PubMed 29659375Suso-Ribera C, Castilla D, Zaragoza I, Ribera-Canudas MV, Botella C, Garcia-Palacios A. Validity, Reliability, Feasibility, and Usefulness of Pain Monitor: A Multidimensional Smartphone App for Daily Monitoring of Adults With Heterogenous Chronic Pain. Clin J Pain. 2018 Oct;34(10):900-908. doi: 10.1097/AJP.0000000000000618.
- Results publication: PubMed 32377676Yoshida Y, Patil SJ, Brownson RC, Boren SA, Kim M, Dobson R, Waki K, Greenwood DA, Torbjornsen A, Ramachandran A, Masi C, Fonseca VA, Simoes EJ. Using the RE-AIM framework to evaluate internal and external validity of mobile phone-based interventions in diabetes self-management education and support. J Am Med Inform Assoc. 2020 Jun 1;27(6):946-956. doi: 10.1093/jamia/ocaa041.
- Results publication: PubMed 35612886Jakob R, Harperink S, Rudolf AM, Fleisch E, Haug S, Mair JL, Salamanca-Sanabria A, Kowatsch T. Factors Influencing Adherence to mHealth Apps for Prevention or Management of Noncommunicable Diseases: Systematic Review. J Med Internet Res. 2022 May 25;24(5):e35371. doi: 10.2196/35371.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Na Young Kim, MD, PhD principal investigator
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Wearable devices Monitoring sys-Assisted Home Rehabilitation Program in people with Gait Disorders, Neurologic, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-minute walking test results (time frame: This test results will be assessed two times: baseline, exit (after 6 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06410755, which also lists 54 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.