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

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.

Conditions

• Gait Disorders, Neurologic

Interventions

DEVICE

Integrated Wearable devices Monitoring sys-Assisted Home Rehabilitation Program

The researcher provides weekly feedback via telephone to participants in the intervention group based on exercise amount, walking level, and activity data collected through the integrated wearable monitoring system, which includes an insole-type gait analyzer, a wrist-worn activity tracker, and a self-report mobile application. Data collection stability is regularly monitored, and any abnormalities or device-related issues are addressed promptly and documented through telephone communication or in-person visits when necessary.

Sponsors & Collaborators

• Korea Health Industry Development Institute

  collaborator OTHER_GOV

• Yonsei University

  lead OTHER

Principal Investigators

• Na Young Kim, MD, PhD · Severance Hospital

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

19 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-03-12

Primary Completion

2024-04-23

Completion

2026-12-31

Countries

• South Korea

Study Locations