An interventional study of Integrated Wearable devices Monitoring sys-Assisted Home Rehabilitation Program in Gait Disorders, Neurologic, sponsored by Yonsei University. Active, not recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-07-27.
Sponsored by Yonsei University · Not applicable, Interventional, and Health services research
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:
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.
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.
327 studies on the registry are indexed under Gait Disorders, Neurologic; 54 are open to participants now.
This study's enrollment of 120 is above the median of 30 across 246 interventional studies indexed under Gait Disorders, Neurologic.
Browse Gait Disorders, Neurologic studies →Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.
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Exclusion Criteria:
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.
Device: Integrated Wearable devices Monitoring sys-Assisted Home Rehabilitation Program
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.
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.
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. 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.
Time frame: This test results will be assessed two times: baseline, exit (after 6 weeks)
body composition analysis
This is a test performed to check the subject's limb muscle mass, and the test method is as follows. 1. Perform body composition analysis based on bioimpedance analysis. 2. 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. 3. 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.
Time frame: 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(%).
Time frame: 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.
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)
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.
Time frame: 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.
Time frame: 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.
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)
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'.
Time frame: 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. 1. The subject sits in the correct posture and bends the elbows to 90 degrees. 2. 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. 3. Measure the left and right three times each and record the maximum value.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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)
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.
Time frame: 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. 1. 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. 2. 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. 3. Walking speed test: After having the subject walk 3m, the examiner measures the time and scores according to the criteria below.
Time frame: 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. 1. 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. 2. 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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. 1. A total straight path of 14 meters is prepared, with the first and last 2 meters serving as non-measurement zones. 2. 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.
Time frame: This test results will be assessed two times: baseline, exit (after 6 weeks)
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Yonsei University