Active — Not RecruitingNot Applicable

Home-based Rehabilitation Monitoring System With Wearable Devices and Self-Report Application

South Korea120 participantsStarted 2024-03-12

Plain-language summary

The goal of this clinical trial is to evaluate whether monitoring and providing feedback on the performance of a home-based exercise program using an integrated wearable monitoring system improves physical and cognitive function, and activity level in participants with stroke. The integrated wearable monitoring system consists of an insole-type gait analyzer for objective gait assessment, a wrist-worn activity tracker for monitoring daily physical activity, and a self-report mobile application for delivering feedback and collecting participant-reported information. This study also aims to assess participant satisfaction with the integrated wearable monitoring system during a 6-week home-based gait rehabilitation program. The main questions this study aims to answer are: 1. What effect does monitoring and providing feedback using an integrated wearable monitoring system have on physical and cognitive function, and activity level during a home-based gait rehabilitation program? 2. How satisfied are participants with the use of the integrated wearable monitoring system? Researchers will compare an intervention group that receives the integrated wearable monitoring system with a control group that performs the same home-based exercise program without wearable monitoring and feedback. Participants in the intervention group will receive an insole-type gait analyzer, a wrist-worn activity tracker, and access to a mobile application, along with training in a prescribed home-based exercise program. During the 6-week intervention period, participants will wear the insole-type gait analyzer and the activity tracker while performing the home-based exercise program and will use the mobile application to receive feedback and self-report selected daily health-related information. After completion of the 6-week program, the investigators will conduct a satisfaction survey to evaluate participant experience with the integrated wearable monitoring system.

Who can participate

Age range19 Years

SexALL

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Inclusion criteria

✓. Adults over 19 years of age
✓. Patients with a score of 2-3 on the Modified Rankin Scale who are ambulatory
✓. Patients who visited Yongin Severance Hospital who understood and agreed to the study and completed the informed consent form

Exclusion criteria

✕. Those with contraindications to lower extremity weight bearing such as severe lower extremity joint contractures, osteoporosis, or untreated fractures
✕. Progressive or unstable brain disease
✕. In addition to above, those who have clinically significant findings that are deemed inappropriate for this study in the medical judgment of the study director or person in charge

What they're measuring

6-minute walking test results

Timeframe: This test results will be assessed two times: baseline, exit (after 6 weeks)

Trial details

NCT IDNCT06410755

SponsorYonsei University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-04-23

View on ClinicalTrials.gov More Gait Disorders, Neurologic trials