Home-based Gait Rehabilitation Service Using Instrumented Insole

May 7, 2024 updated by: Yonsei University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Na Young Kim, MD, PhD
  • Phone Number: +82 010 9127 4482
  • Email: kny8452@yuhs.ac

Study Contact Backup

  • Name: Seung Ick Choi
  • Phone Number: +82 010 8821 5297
  • Email: rehab1@yuhs.ac

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Yongin-si, Gyeonggi-do, Korea, Republic of, 16995
        • Recruiting
        • Yongin Severance Hospital
        • Contact:
          • Seung Ick Choi
          • Phone Number: +82 010 8821 5297
          • Email: rehab1@yuhs.ac
        • Contact:
        • Principal Investigator:
          • Na Young Kim, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Insole wearing group receiving monitoring and feedback
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.
Device: Monitoring system using a insole-type gait analyzer
The researcher provides feedback over the phone once a week in accordance with the subjects' amount of exercise and walking level collected only to the experimental group using the insole-type gait analysis system. Check the stability of data collection, and if an abnormality occurs, take action and record it by phone or in person
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6-minute walking test results
Time Frame: This test results will be assessed two times: baseline, exit (after 6 weeks)

While wearing the insole gait analyzer, the subject performs a 6-minute gait test, which is the test that most closely approximates everyday walking, and the examiner provides feedback on the gait by comparing the average parameter data extracted from the insole gait analyzer to a normal gait reference. The above evaluation is a test conducted to evaluate walking endurance, and the evaluation method is as follows.

  1. Install a colored cone with 30m on the floor and prepare a stopwatch.
  2. Instruct the subject to travel as many times as possible in a straight line of 30m for 6 minutes.
  3. Teach that they can rest and stop during the test and use only permitted phrases ('You're doing well', 'Keep going').
  4. The examiner records the total distance traveled and the pattern and occurrence time of the abnormal gait.
This test results will be assessed two times: baseline, exit (after 6 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
body composition analysis
Time Frame: This test results will be assessed two times: baseline, exit (after 6 weeks)

This is a test performed to check the subject's limb muscle mass, and the test method is as follows.

  1. Perform body composition analysis based on bioimpedance analysis.
  2. To ensure accurate measurement, the test subject is instructed to empty his/her bladder before the test and not to consume caffeinated beverages, eat, drink, or perform strenuous exercise for one hour prior to the test.
  3. To correct for muscle mass differences due to height, use the calculated value of limb muscle mass (Appendicular skeletal mass) divided by the square of the height.
This test results will be assessed two times: baseline, exit (after 6 weeks)
Spatiotemporal parameters of walking
Time Frame: This test results will be assessed two times: baseline, exit (after 6 weeks)
Spatiotemporal parametric data of gait collected while the subject is performing a home-based activity wearing an insole gait analyzer, recording total steps, steps per minute(steps/min), gait speed(km/h), distance walked(m), stride length(m), and swing phase rate(%).
This test results will be assessed two times: baseline, exit (after 6 weeks)
Korea-Mini Mental State Examination
Time Frame: This test results will be assessed two times: baseline, exit (after 6 weeks)
A test that assesses the degree of overall cognitive impairment, taking into account a person's level of education, and the test assesses time and place perception, attention and calculation, memory, language, and spatial and temporal organization. The examiner asks questions corresponding to the items on the test sheet below and record a score for the answers.
This test results will be assessed two times: baseline, exit (after 6 weeks)
Short form of Geriatric Depression Scale (Korean version of Short form of Geriatric Depression Scale)
Time Frame: This test results will be assessed two times: baseline, exit (after 6 weeks)

This is a test used to assess the level of depression in older adults and able to assess quickly the level of depression in the elderly and identify risk. The examiner asks the subject questions according to the questionnaire below, checks items according to the answers, and scores them according to the evaluation method.

This consists of 15 items and is the most commonly used version due to its brevity and ease of use. It can typically be completed in 5 to 7 minutes.

Each item on the GDS is scored 0 or 1, depending on whether the symptom of depression is absent or present according to the patient's response. The total score is calculated by summing up the scores for each item. Generally, a score of 0 to 5 is considered normal, depending on the setting and clinical judgment. Scores of 5 or more suggest depression, with scores of 10 or higher almost always indicative of depression.
This test results will be assessed two times: baseline, exit (after 6 weeks)
Korean version of Sarcopenia Screening Questionnaire
Time Frame: This test results will be assessed two times: baseline, exit (after 6 weeks)

Questionnaire that evaluates the decrease in muscle strength and functional performance along with a decrease in muscle mass and it is highly related to aging and chronic diseases. The evaluation method is conducted by having the examiner ask the subject about the following questionnaire, and the scores for the answers are recorded.

It consists of 5 questions, and each question is scored 0-2 points. The higher the score, the higher the risk of sarcopenia. If the score is 4 or higher, sarcopenia may be suspected.
This test results will be assessed two times: baseline, exit (after 6 weeks)
Functional Ambulation Category
Time Frame: This test results will be assessed two times: baseline, exit (after 6 weeks)
Assessment of the subject's walking function. The examiner observes the subject's gait and records a score based on the criteria in the assessment sheet below.
This test results will be assessed two times: baseline, exit (after 6 weeks)
Korean version of the International Physical Activity Questionnaire (K-IPAQ)
Time Frame: This test results will be assessed two times: baseline, exit (after 6 weeks)
Tests that assess various aspects of an individual's daily physical activity and it can provide information about activity level. The examiner questions the subject based on the questionnaire below, records related information, calculates the total activity time and intensity, and classifies it as 'low', 'medium', and 'high'.
This test results will be assessed two times: baseline, exit (after 6 weeks)
Grip Strength Test
Time Frame: This test results will be assessed two times: baseline, exit (after 6 weeks)

A test that evaluates the subject's grip strength, and the evaluation method is as follows.

  1. The subject sits in the correct posture and bends the elbows to 90 degrees.
  2. Place the handle of the measuring device between the first and second joints of each finger and hold it tightly according to the examiner's instructions.
  3. Measure the left and right three times each and record the maximum value.
This test results will be assessed two times: baseline, exit (after 6 weeks)
Clinical Frailty Scale
Time Frame: This test results will be assessed two times: baseline, exit (after 6 weeks)

Test to assess the health status and frailty of elderly and assesses the health and vulnerability of the elderly after the program ends.

The scale ranges from 1 to 9, with each level described through specific criteria that reflect the degree of fitness or frailty, a higher score means poorer health.
This test results will be assessed two times: baseline, exit (after 6 weeks)
European Quality of Life-5 Dimensions
Time Frame: This test results will be assessed two times: baseline, exit (after 6 weeks)

It consists of items evaluating exercise ability, self-management, daily activities (work, study, housework, family or leisure activities), pain/discomfort, and anxiety/depression, and examiner evaluates according to the form below.

Participants will be asked to answer each question with 3 items, and a higher score means more health problems, minimum score is 5 and maximum score is 15.
This test results will be assessed two times: baseline, exit (after 6 weeks)
Mini-Nutritional Assessment
Time Frame: This test results will be assessed two times: baseline, exit (after 6 weeks)
An assessment of nutritional status and risk of undernutrition or malnutrition using questionnaire to assess the nutritional status of a subject, and the examiner records a score based on the criteria in the questionnaire below.
This test results will be assessed two times: baseline, exit (after 6 weeks)
Assessment of activities of daily living and instrumental activities of daily living (ADL & I-ADL assessment)
Time Frame: This test results will be assessed two times: baseline, exit (after 6 weeks)
This assessment uses a questionnaire that assesses the nutritional status of subjects to determine their nutritional status and whether they are undernourished or at risk of being undernourished, and the examiner records a score based on the criteria in the questionnaire below.
This test results will be assessed two times: baseline, exit (after 6 weeks)
Short Physical Performance Battery (SPPB)
Time Frame: This test results will be assessed two times: baseline, exit (after 6 weeks)

This is a test that evaluates three areas to assess a subject's lower extremity physical functioning, and it measures and records scores in three areas: balance, getting up from a chair, and walking speed.

  1. Balance test: Line up feet in parallel and hold for 10 seconds. If possible, perform this test in a semi-upright position, then straighten feet and repeat 3 times.
  2. Chair stand-up test: Perform the stand-up test 5 times from a chair. The examiner measures the time and records the score according to the criteria below.
  3. Walking speed test: After having the subject walk 3m, the examiner measures the time and scores according to the criteria below.
This test results will be assessed two times: baseline, exit (after 6 weeks)
Timed up and go test (TUG)
Time Frame: This test results will be assessed two times: baseline, exit (after 6 weeks)

The above test assesses walking speed along with balance ability during walking, and this is performed as follows.

  1. A 46 cm high armrest chair, a color cone is placed at a distance of 3 meters from the chair and the subject is instructed to sit on the chair.
  2. In the preparation phase, the subject leans against the chair backrest and places his/her arms on the armrests, then stands up on the instruction "Start", walks 3 meters, turns around the color cone, returns to the starting point and sits down on the chair.
This test results will be assessed two times: baseline, exit (after 6 weeks)
Berg Balance Scale
Time Frame: This test results will be assessed two times: baseline, exit (after 6 weeks)
The above test assesses static and dynamic balance, in which the examiner instructs the subject to perform the 14 movements below and then scores them against a set of criteria.
This test results will be assessed two times: baseline, exit (after 6 weeks)
Cybex isokinetic strength evaluation
Time Frame: This test results will be assessed two times: baseline, exit (after 6 weeks)
A test to measure lower extremity strength and power using the isokinetic exercise equipment CYBEX, and 5 repetitions of 60/60 degrees per second and 15 repetitions of 150/150 degrees per second are performed to measure Peak Torque (Nm), Total Work (J), Average power per repetition (W), and Fatigue Index (%) of the lower extremity muscles.
This test results will be assessed two times: baseline, exit (after 6 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Collaborators

Korea Health Industry Development Institute

Investigators

  • Principal Investigator: Na Young Kim, MD, PhD, Severance Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2024

Primary Completion (Actual)

April 23, 2024

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

April 21, 2024

First Submitted That Met QC Criteria

May 7, 2024

First Posted (Actual)

May 13, 2024

Study Record Updates

Last Update Posted (Actual)

May 13, 2024

Last Update Submitted That Met QC Criteria

May 7, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9-2023-0194

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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