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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06410755
• Other study ID #: 9-2023-0194
• Status: Recruiting
• Phase: N/A
• Start date: March 12, 2024
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Yonsei University
• Contact: Na Young Kim, MD, PhD
• Phone: +82 010 9127 4482
• Email: kny8452[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2025
• Est. primary completion date: April 23, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Nervous System Diseases

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Yongin Severance Hospital	Yongin-si	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Yonsei University	Korea Health Industry Development Institute

Country where clinical trial is conducted

Korea, Republic of, 

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* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6-minute walking test results	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.; Install a colored cone with 30m on the floor and prepare a stopwatch.; Instruct the subject to travel as many times as possible in a straight line of 30m for 6 minutes.; Teach that they can rest and stop during the test and use only permitted phrases ('You're doing well', 'Keep going').; 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	body composition analysis	This is a test performed to check the subject's limb muscle mass, and the test method is as follows.; Perform body composition analysis based on bioimpedance analysis.; 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.; 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)
Secondary	Spatiotemporal parameters of walking	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)
Secondary	Korea-Mini Mental State Examination	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)
Secondary	Short form of Geriatric Depression Scale (Korean version of Short form of Geriatric Depression Scale)	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)
Secondary	Korean version of Sarcopenia Screening Questionnaire	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)
Secondary	Functional Ambulation Category	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)
Secondary	Korean version of the International Physical Activity Questionnaire (K-IPAQ)	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)
Secondary	Grip Strength Test	A test that evaluates the subject's grip strength, and the evaluation method is as follows.; The subject sits in the correct posture and bends the elbows to 90 degrees.; 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.; 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)
Secondary	Clinical Frailty Scale	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)
Secondary	European Quality of Life-5 Dimensions	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)
Secondary	Mini-Nutritional Assessment	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)
Secondary	Assessment of activities of daily living and instrumental activities of daily living (ADL & I-ADL assessment)	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)
Secondary	Short Physical Performance Battery (SPPB)	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.; 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.; 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.; 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)
Secondary	Timed up and go test (TUG)	The above test assesses walking speed along with balance ability during walking, and this is performed as follows.; 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.; 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)
Secondary	Berg Balance Scale	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)
Secondary	Cybex isokinetic strength evaluation	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)