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

Condition(s) studied

Investigational drug(s) / intervention(s)

hip-assisted wearable robot: A 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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Telehealth Usability Questionnaire (TUQ) — At the end of the 2-week intervention (after session 4)
  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.

Trial sites (1)

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