Evaluate the Effectiveness and Safety of At-Home Rehabilitation Gait Training Using a Hip-assisted Wearable Robot in Stroke Patients | NCT07716475

NCT07716475

Overview

NCT ID: NCT07716475
Lead Sponsor: Yonsei UniversityOTHER
Official Title: 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
Brief 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.

Status and Timeline

Status: Recruiting
Last Update Posted: Jul 21, 2026Actual
Start Date: Jul 6, 2026Actual
Primary Completion Date: Sep 30, 2026Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

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)

Exclusion Criteria:

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

Persons unable to maintain a sitting posture or a standing posture on their own

Persons with severe lower-extremity spasticity (Modified Ashworth Scale (MAS) grade 2 or higher)

Persons who cannot cooperate with gait therapy using the robot-assisted orthopedic exercise device due to severe cognitive decline (Mini-Mental State Examination score < 20), delirium, or severe language function impairment

Persons who cannot maintain prolonged standing or walking due to underlying conditions such as orthostatic hypotension or reduced cardiopulmonary function

Persons with other concomitant conditions affecting gait, such as peripheral neuropathy or parkinsonism due to alcoholism or severe diabetes

Pregnant women or patients with the possibility of pregnancy

Persons currently participating in another clinical trial

Persons at high risk in the event of a fall or bleeding due to a coagulation disorder or the like

Persons with a height less than 140 cm or greater than 190 cm

Persons for whom wearing the robot is not possible

Persons with clinically significant findings that, in the medical judgment of the principal investigator or a sub-investigator, are considered inappropriate for this study other than the above

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 8Estimated
Primary Purpose: Health Services Research
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Na Young Kim, MD, PhDContact
kny8452@yuhs.ac+82 010 9127 4482

Overview

Status and Timeline

Participation Criteria

Study Plan

Contacts and Locations

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