A Study to Evaluate the Effectiveness and Safety of At-Home Rehabilitation Gait Training Using a Hip-assisted Wearable Robot in Stroke Patients: An Investigator-Initiated, Single-Center, Single-Arm Exploratory Trial
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
• Patients with a Functional Ambulatory Category score below 4
• Persons who can sit without assistance at the edge of a bed and can stand for 10 seconds with or without assistance
• Persons with sufficient cognitive ability to follow simple instructions and understand the content and purpose of the study (Mini-Mental State Examination score \>= 20)