Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06410755
Status:
RECRUITING
Last Update Posted:
2024-05-13
First Post:
2024-04-21
Brief Title:
Home-based Gait Rehabilitation Service Using Instrumented Insole
Sponsor:
Yonsei University
Organization:
Yonsei University
Study Overview
Official Title:
Research on Development of Home-based Gait Rehabilitation Service Using Insole-type Gait Analyzer
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None