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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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 80
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Republic of Korea
Yongin Severance Hospital
RECRUITING
Yongin-si
Contact Information
Primary
Na Young Kim, MD, PhD
kny8452@yuhs.ac
+82 010 9127 4482
Backup
Seung Ick Choi
rehab1@yuhs.ac
+82 010 8821 5297
Time Frame
Start Date: 2026-07-06
Estimated Completion Date: 2027-07-30
Participants
Target number of participants: 8
Treatments
Experimental: Intervention group (Home-based Robot-assisted Gait training group)
Participants receive home-based robot-assisted gait training using a hip-assisted wearable robot. A visiting physical or occupational therapist delivers the training at the participant's home for 4 sessions over 2 weeks, 30 minutes per session, under a physician's prescription and supervision.
Related Therapeutic Areas
Sponsors
Leads: Yonsei University
Collaborators: Korea Health Industry Development Institute

This content was sourced from clinicaltrials.gov