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

February 5, 2025 updated by: Yonsei University

Usefulness of Insole-type Gait Analyzer in Collecting Gait Data From Patients With Gait Disturbance

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

600

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 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 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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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."
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
TUG test session will last approximately 5 minutes. and TUG test will be performed at baseline.
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.
This K-SSQ session will last approximately 1 minutes, it will be performed at baseline.
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'.
This K-IPAQ session will last approximately 3 minutes, it will be performed at baseline.

Collaborators and Investigators

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

Sponsor

Yonsei University

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)

June 1, 2021

Primary Completion (Estimated)

May 31, 2025

Study Completion (Estimated)

May 31, 2025

Study Registration Dates

First Submitted

May 21, 2024

First Submitted That Met QC Criteria

June 2, 2024

First Posted (Actual)

June 5, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 5, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9-2021-0055

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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