Evaluate the Effectiveness and Safety of At-Home Rehabilitation Gait Training Using a Hip-assisted Wearable Robot in Stroke Patients

Stroke

Home-based rehabilitation, Robot-assisted gait training, Telehealth, Exoskeleton Device, Stroke

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.

After obtaining written consent, a screening test is performed. In the screening test, after taking a history of the subject's baseline symptoms and signs, the past history and medication history are confirmed, vital signs are measured, and a physical examination is conducted, and the overall gait status such as whether assistive devices are used during gait and the gait pattern is assessed. Subjects who pass the screening test undergo the initial assessment within 7 days. The initial assessment is conducted including the 2-Minute Walk Test, spatiotemporal gait parameters, the Berg Balance Scale, and subjects who complete the initial assessment begin robot-assisted gait training on the same day. After the initial assessment, gait training using the hip-assisted wearable robot is performed in the home or an indoor space near the home twice a week for 2 weeks, a total of 4 times, for 30 minutes each. The interval between each intervention visit is set not to exceed 5 days. After the end of the 2 weeks of robot-assisted gait training, on the day of completion, the end-of-study assessment is performed identically to the initial assessment, and a satisfaction assessment for the hip-assisted wearable robot is conducted. In addition, when a device abnormality occurs, measures are taken and the relevant details are recorded, the usability of the hip-assisted wearable robot is analyzed, the gait and balance function assessment results in the non-wearing/wearing states of the hip-assisted wearable robot are statistically compared before and after gait training, and the burden and satisfaction assessments of the hip-assisted wearable robot are analyzed.

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South Korea