Home-based Gait Rehabilitation Service Using Instrumented Insole

Gait Disorders, Neurologic Clinical Trial

Official title: Research on Development of Home-based Gait Rehabilitation Service Using Insole-type Gait Analyzer

Status Recruiting

Clinical Trial Summary

The goal of this clinical trial is to learn if monitoring and providing feedback on the performance of a home-based exercise program using an insole gait analyzer to treat participants who have gait disorder. The investigators also learn about the satisfaction level of this insole type gait analysis system.

The main questions it aims to to answer are:

• What effect does providing monitoring and feedback using an insole-type gait analyzer have on walking patterns?

• How satisfied are the experimental group participants with the use of the insole gait analyzer?

Researchers will compare the experimental group that receives the insole-type gait analyzer with the control group that does not receive it.

Participants will:

• Receive an insole-type gait analyzer and receive training in a home-based exercise program.

• During the 6-week program, participants will wear an insole-type gait analyzer and perform a home-based exercise program.

• The investigators will conduct a satisfaction survey after 6 weeks.

Clinical Trial Description

A screening test is conducted after obtaining consent. The screening test assesses whether participants, regardless of their use of assistive devices, can walk independently for more than 10 meters, following an inquiry into their baseline symptoms and signs. Subjects who pass the screening test are randomized into an experimental and a control group, both of which undergo an initial assessment, are provided with information about their current gait status and normal gait and are instructed in a home-based exercise program.

The researcher provides the insole gait analyzers to the experimental group, trains them on how to use them, and instructs them to wear them as much and for as long as possible so that their usage time and gait patterns are recorded. The researcher provides feedback over the phone once a week based on the collected measurement data. The control group was not provided with an insole-type gait analyzer or feedback on their exercise.

At the end of the home-based exercise program after 6 weeks, an exit assessment is conducted, identical to the initial assessment, and the experimental group is asked to rate their satisfaction with the insole gait analyzer.

Measures are taken and recorded when a device malfunction occurs, the use and satisfaction level of the insole-type gait analyzer in the experimental group are analyzed, and evaluation indicators before and after the program for the experimental and control groups are compared. ;

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Nervous System Diseases

• NCT number: NCT06410755
• Study type: Interventional
• Source: Yonsei University
• Contact: Na Young Kim, MD, PhD
• Phone: +82 010 9127 4482
• Email: kny8452@yuhs.ac
• Status: Recruiting
• Phase: N/A
• Start date: March 12, 2024
• Completion date: December 2025