The goal of this clinical trial is to learn whether a wearable monitoring system can help adults who have had a stroke get more out of a home exercise program. The system tracks how participants walk and move, then gives them feedback. Researchers want to know if this feedback improves walking, thinking and memory, and daily activity.
The wearable monitoring system has three parts:
A shoe insole sensor that measures how a person walks A wrist band that tracks daily activity, like a fitness watch A mobile app that gives feedback and lets participants report how they feel
The main questions this study aims to answer are:
Does feedback from the wearable system improve physical function, thinking and memory, and daily activity during a home exercise program? How satisfied are participants with using the wearable system?
Researchers will compare two groups. Both groups do the same home exercise program for 6 weeks. One group uses the wearable system and gets feedback. The other group does the program without the wearable system or feedback. This comparison shows whether the feedback itself makes a difference.
Who can take part: adults who have had a stroke and \[key eligibility in plain words, e.g., "can walk a short distance with or without help"\]. The study plans to enroll about \[number\] participants.
Participants in the wearable group will:
Get an insole sensor, a wrist activity tracker, and access to a mobile app Learn a home exercise program from the study team Wear the insole sensor and activity tracker while exercising at home for 6 weeks Use the app to see their feedback and report daily health information Complete a survey about their experience at the end
Participants in the comparison group will:
Do the same home exercise program for 6 weeks, without the wearable system or feedback.
Adults aged 19 years or older and under 80 years
Persons diagnosed with cerebral infarction or intracerebral hemorrhage confirmed by magnetic resonance imaging or computed tomography
Persons for whom at least 1 month has elapsed since the diagnosis of stroke
Persons showing a spastic hemiplegic gait pattern due to stroke
Persons with contraindications to lower-extremity weight bearing, such as severe lower-extremity joint contracture or an untreated fracture
Persons for whom wearing the device is difficult due to skin disease or open wounds
Persons with a severe difference in the length of the two lower extremities
Persons with severe deformity or joint contracture in the lower extremities
Single group
hip-assisted wearable robot
DeviceA hip-assisted wearable robot (wearable gait-assist robot) that assists flexion and extension of the hip joint during walking. The battery-powered device is controlled through a paired mobile application via Bluetooth, and its assistive force can be adjusted to each participant. A visiting physical or occupational therapist applies the device and delivers gait training at the participant's home for 4 sessions over 2 weeks, 30 minutes per session, under a physician's prescription and supervision.
Telehealth Usability Questionnaire (TUQ)
Usability of the home-based robot-assisted gait rehabilitation service, measured with a questionnaire based on the Telehealth Usability Questionnaire (TUQ). Items are rated on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree); higher scores indicate better usability. Total and item scores are summarized.
Distance of 2-Minute Walk Test (2MWT)
Patients are instructed to walk back as many times as possible within 2 minutes. The examiner records the total distance covered, abnormal gait patterns, and the time of occurrence of any gait deviations.
Spatiotemporal Parameters of Gait: Cadence
While the participant performs the test wearing an insole-type gait analyzer, spatiotemporal gait parameters are collected and recorded. Cadence: The number of steps taken per minute, measured in steps per minute (spm).
Spatiotemporal Parameters of Gait : Total Step Count
While the participant performs the test wearing an insole-type gait analyzer, spatiotemporal gait parameters are collected and recorded. Total Step Count: The total number of steps taken during walking.
Spatiotemporal Parameters of Gait : Self-Selected Walking Speed
While the participant performs the test wearing an insole-type gait analyzer, spatiotemporal gait parameters are collected and recorded. Self-Selected Walking Speed: The participant's walking speed when walking naturally at a comfortable pace.
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Yonsei University
Lead sponsor
Severance Hospital
Sponsor institution
Korea Health Industry Development Institute
Collaborator
