Gait Disorders, Neurologic
Conditions
Keywords
gait parameters, smart insole, home-based exercise, monitoring system, rehabilitation
Brief 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. 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: 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.
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.
Interventions
DEVICEIntegrated Wearable devices Monitoring sys-Assisted Home Rehabilitation Program
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.
Sponsors
Yonsei University
Korea Health Industry Development Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Masking description
Anonymization is achieved by using the unique number of the wearable devices issued to the subject, and data collected through the application will be stored in accordance with the medical device company's security policy and will be discarded after the end of the study, and will be deidentified before being forwarded to the medical device company. De-anonymization is limited to cases where it is necessary in relation to the individual's treatment
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults over 19 years of age 2. Patients with a score of 2-3 on the Modified Rankin Scale who are ambulatory 3. Patients who visited Yongin Severance Hospital who understood and agreed to the study and completed the informed consent form
Exclusion criteria
1. Those with contraindications to lower extremity weight bearing such as severe lower extremity joint contractures, osteoporosis, or untreated fractures 2. Progressive or unstable brain disease 3. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6-minute walking test results | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| body composition analysis | This test results will be assessed two times: baseline, exit (after 6 weeks) | 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. |
| Spatiotemporal parameters of walking | This test results will be assessed two times: baseline, exit (after 6 weeks) | 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(%). |
| Korea-Mini Mental State Examination | This test results will be assessed two times: baseline, exit (after 6 weeks) | 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. |
| Short form of Geriatric Depression Scale (Korean version of Short form of Geriatric Depression Scale) | This test results will be assessed two times: baseline, exit (after 6 weeks) | 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. |
| Korean version of Sarcopenia Screening Questionnaire | This test results will be assessed two times: baseline, exit (after 6 weeks) | 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. |
| Functional Ambulation Category | This test results will be assessed two times: baseline, exit (after 6 weeks) | 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. |
| Korean version of the International Physical Activity Questionnaire (K-IPAQ) | This test results will be assessed two times: baseline, exit (after 6 weeks) | 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'. |
| Grip Strength Test | This test results will be assessed two times: baseline, exit (after 6 weeks) | 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. |
| Clinical Frailty Scale | This test results will be assessed two times: baseline, exit (after 6 weeks) | 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. |
| European Quality of Life-5 Dimensions | This test results will be assessed two times: baseline, exit (after 6 weeks) | 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. |
| Mini-Nutritional Assessment | This test results will be assessed two times: baseline, exit (after 6 weeks) | 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. |
| Assessment of activities of daily living and instrumental activities of daily living (ADL & I-ADL assessment) | This test results will be assessed two times: baseline, exit (after 6 weeks) | 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. |
| Short Physical Performance Battery (SPPB) | This test results will be assessed two times: baseline, exit (after 6 weeks) | 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. |
| Timed up and go test (TUG) | This test results will be assessed two times: baseline, exit (after 6 weeks) | 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. |
| Berg Balance Scale | This test results will be assessed two times: baseline, exit (after 6 weeks) | 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. |
| Cybex isokinetic strength evaluation | This test results will be assessed two times: baseline, exit (after 6 weeks) | 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. |
| Application survey response rate | This test results will be assessed up to 6 weeks | 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. |
| K-QEUST-based wearable device satisfaction assessment | This test result will be assessed once at the end of the 6-week intervention. | 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 |
| 10m Walk Test | This test results will be assessed two times: baseline, exit (after 6 weeks) | 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. |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORNa Young Kim, MD, PhD
Severance Hospital
Outcome results
None listed