Usefulness of Insole-type Gait Analyzer in Collecting Gait Data From Patients With Gait Disturbance
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Yonsei University
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- Timed up and go test (TUG)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •adults aged 19 and over (based on the age on their national ID at the time of consent)
- •adults complaining subjective gait or balance disorders
- •individuals who voluntarily agree to participate in the study and sign a consent form
Exclusion Criteria
- •individuals unable to walk independently on flat ground for more than 6 minutes
- •individuals who cannot read ordinary print with glasses due to visual reasons
- •individuals who cannot understand conversation even with a hearing aid due to auditory reasons
- •individuals with clinically significant disorders in the cardiovascular, gastrointestinal, respiratory, or endocrine systems
- •individuals considered clinically unsuitable for the trial by the trial manager or person in charge based on significant medical findings.
Arms & Interventions
Insole wearing group
Patients with subjective gait and balance disorders will wear insole-type gait analyzer and walk, then the collected data will be examined."
Intervention: insole-type gait analyzer (Device)
Outcomes
Primary Outcomes
Timed up and go test (TUG)
Time Frame: 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
Time Frame: 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)
Time Frame: 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'.
Secondary Outcomes
No secondary outcomes reported