Home-based Gait Rehabilitation Service Using Instrumented Insole

Yonsei University

Status: Enrolling

Conditions: Gait Disorders, Neurologic

Treatments: Device: Monitoring system using a insole-type gait analyzer

Study type: Interventional

Funder types: Other

Identifiers

NCT06410755

9-2023-0194

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Those with contraindications to lower extremity weight bearing such as severe lower extremity joint contractures, osteoporosis, or untreated fractures
2. Progressive or unstable brain disease
3. 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

30 participants in 2 patient groups

Insole wearing group receiving monitoring and feedback

Experimental group

Description:

The experimental group wears the insole gait analyzer and is asked to wear the insole gait analyzer as much and as long as possible during outdoor activities. Researchers provide feedback to subjects once a week based on the collected measurement data. After 6 weeks, usability and satisfaction evaluation of the insole type gait analysis system will be conducted.

Treatment:

Device: Monitoring system using a insole-type gait analyzer

Control group

No Intervention group

Description:

The control group is trained in the same exercise program as the experimental group, but not receives the insole gait analyzers and not receives any exercise feedback.