Analyzing Gait Pattern Using Insole-type Gait Analyzer in Patient With Gait Disturbance

Not Applicable

Recruiting

• Conditions: Gait Disorders, Neurologic
• Interventions: Device: insole-type gait analyzer

• Registration Number: NCT06442982
• Lead Sponsor: Yonsei University

Brief Summary

The goal of this clinical trial is to explore the usefulness of information from insole-type gait analyzer in adults with subjective gait and balance disorders.

The main questions it aims to answer are:

How useful is an insole-type gait analyzer for collecting gait data from patients with gait disturbances?

Researchers will explore the usefulness of collected data and does not establish a control group.

Participants will:

Participants will conduct survey and perform the Timed up and go test wearing an insole-type gait analyzer.

Detailed Description

A screening test is conducted after obtaining consent. The screening test assesses whether participants can walk independently on flat ground, following an inquiry into their baseline symptoms and signs.

Participants will conduct A history survey, a sarcopenia questionnaire, and the International Physical Activity Questionnaire (IPAQ).

Participants will wear insole-type gait analyzer and undergo the Timed Up and Go test.

The measurement values of the accelerometer and pressure sensors recorded in the insole-type gait analyzer will be examined to determine the presence of missing or outlier data. Researchers will explore the data collection frequency and analysis methods to extract clinically significant data.

Study Timeline

• Study Start: 2021-06-01
• Study First Submitted: 2024-05-21
• Study First Submitted QC: 2024-06-02
• Study First Posted: 2024-06-05
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-02-10
• Primary Completion: 2025-05-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1. adults aged 19 and over (based on the age on their national ID at the time of consent)
2. adults complaining subjective gait or balance disorders
3. individuals who voluntarily agree to participate in the study and sign a consent form

Exclusion Criteria

1. individuals unable to walk independently on flat ground for more than 6 minutes
2. individuals who cannot read ordinary print with glasses due to visual reasons
3. individuals who cannot understand conversation even with a hearing aid due to auditory reasons
4. individuals with clinically significant disorders in the cardiovascular, gastrointestinal, respiratory, or endocrine systems
5. individuals considered clinically unsuitable for the trial by the trial manager or person in charge based on significant medical findings.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Insole wearing group	insole-type gait analyzer	Patients with subjective gait and balance disorders will wear insole-type gait analyzer and walk, then the collected data will be examined."

Primary Outcome Measures

Name	Time	Method
Timed up and go test (TUG)	TUG test session will last approximately 5 minutes. and TUG test will be performed at baseline.	The participants will wear insole-type gait analyzer and undergo the Timed Up and Go test.; 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.; 5) Data Verification The measurement values of the accelerometer and pressure sensors recorded in the insole-type gait analyzer will be examined to determine the presence of missing or outlier data. The investigators will explore the data collection frequency and analysis methods to extract clinically significant data.
Korean version of Sarcopenia Screening Questionnaire	This K-SSQ session will last approximately 1 minutes, it will be performed at baseline.	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.
Korean version of the International Physical Activity Questionnaire (K-IPAQ)	This K-IPAQ session will last approximately 3 minutes, it will be performed at baseline.	Tests that assess various aspects of an individual's daily physical activity16 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'.

Trial Locations

Locations (1)

Yongin Severance Hospital; 🇰🇷 Yongin-si, Gyeonggi-do, Korea, Republic of