AzTrials
AzTrials

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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

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.

South Korea1 site
  • Yongin Severance Hospital

    Yongin-si, Gyeonggi-do, 16995

Other trials in South Korea

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:

  1. 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?
  2. 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.

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 groups in NCT06410755
Study groupRoleWhat they receive
Multi-modal Wearable Devices and Self-report Application group receiving monitoring and feedbackExperimentalThe 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 groupNo interventionThe 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.

  1. 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.

    Measured: This test results will be assessed two times: baseline, exit (after 6 weeks)

Secondary outcomes (19)
  1. 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.

    Measured: This test results will be assessed two times: baseline, exit (after 6 weeks)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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.

    Measured: This test results will be assessed two times: baseline, exit (after 6 weeks)

  9. 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)

  10. 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)

  11. 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)

  12. 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)

  13. 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.

    Measured: This test results will be assessed two times: baseline, exit (after 6 weeks)

  14. 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.

    Measured: This test results will be assessed two times: baseline, exit (after 6 weeks)

  15. 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)

  16. 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)

  17. 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

  18. 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.

  19. 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.

    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.

  1. First posted13 May 2024
  2. Study start14 May 2024
  3. Primary completion31 Dec 2025
  4. Study completion31 Dec 2026 (estimated)

Resources

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)
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 3387734
  • Sindhu 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 21820864
  • Hagstromer 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 16925881
  • Wang 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 38096010
  • Snyder 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 28933997
  • Larsen 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 34784293
  • Suso-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 29659375
  • Yoshida 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 32377676
  • Jakob 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 35612886
  • Collins 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 32947994
  • Estrin 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 21051617
  • Kim AL. Effects of structured arm exercise on arteriovenous fistula stenosis in hemodialysis patient. Journal of Korean Biological Nursing Science 2012;14:300-307

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in