Clinical trial NCT06410755: Home-based Gait Rehabilitation Service Using Instrumented Insole
Official title: Research on Development of Home-based Gait Rehabilitation Service Using Insole-type Gait Analyzer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gait Disorders, Neurologic
Keywords: gait parameters
smart insole
home-based exercise
monitoring system
rehabilitation
Lead sponsor: Yonsei University
Sponsor class: OTHER
Collaborators: name: Korea Health Industry Development Institute
First posted: 2024-05-13
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. Overview of study design This is a researcher-led, exploratory clinical study designed with random assignment and lasts for 6 weeks.
2. Experimental group 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.
3. Control group 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 6-minute walking test results
timeFrame: This test results will be assessed two times: baseline, exit (after 6 weeks)
Secondary outcomes:
measure: body composition analysis
timeFrame: This test results will be assessed two times: baseline, exit (after 6 weeks)
measure: Spatiotemporal parameters of walking
timeFrame: This test results will be assessed two times: baseline, exit (after 6 weeks)
measure: Korea-Mini Mental State Examination
timeFrame: This test results will be assessed two times: baseline, exit (after 6 weeks)
measure: Short form of Geriatric Depression Scale (Korean version of Short form of Geriatric Depression Scale)
timeFrame: This test results will be assessed two times: baseline, exit (after 6 weeks)
measure: Korean version of Sarcopenia Screening Questionnaire
timeFrame: This test results will be assessed two times: baseline, exit (after 6 weeks)
measure: Functional Ambulation Category
timeFrame: This test results will be assessed two times: baseline, exit (after 6 weeks)
measure: Korean version of the International Physical Activity Questionnaire (K-IPAQ)
timeFrame: This test results will be assessed two times: baseline, exit (after 6 weeks)
measure: Grip Strength Test
timeFrame: This test results will be assessed two times: baseline, exit (after 6 weeks)
measure: Clinical Frailty Scale
timeFrame: This test results will be assessed two times: baseline, exit (after 6 weeks)
measure: European Quality of Life-5 Dimensions
timeFrame: This test results will be assessed two times: baseline, exit (after 6 weeks)
measure: Mini-Nutritional Assessment
timeFrame: This test results will be assessed two times: baseline, exit (after 6 weeks)
measure: Assessment of activities of daily living and instrumental activities of daily living (ADL & I-ADL assessment)
timeFrame: This test results will be assessed two times: baseline, exit (after 6 weeks)
measure: Short Physical Performance Battery (SPPB)
timeFrame: This test results will be assessed two times: baseline, exit (after 6 weeks)
measure: Timed up and go test (TUG)
timeFrame: This test results will be assessed two times: baseline, exit (after 6 weeks)
measure: Berg Balance Scale
timeFrame: This test results will be assessed two times: baseline, exit (after 6 weeks)
measure: Cybex isokinetic strength evaluation
timeFrame: This test results will be assessed two times: baseline, exit (after 6 weeks)
Other outcomes:
Locations:
city: Yongin-si
country: Korea, Republic of
facility: Yongin Severance Hospital
state: Gyeonggi-do
Study officials:
affiliation: Severance Hospital
name: Na Young Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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