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

NCT06442982 | Recruiting

• 1 other identifier: 9-2021-0055
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Gait Disorders, Neurologic

Keywords

gait analysis; smart insole; neurologic disorder

Outcome Measures

Primary Outcomes (3)

• Timed up and go test (TUG)

  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

  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)

  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.

Study Arms (1)

Insole wearing group

EXPERIMENTAL

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

Interventions

insole-type gait analyzer DEVICE

Patients with subjective gait and balance disorders will wear insole-type gait analyzer and walk, then the collected data will be examined.

Insole wearing group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yongin Severance Hospital

Yongin-si, Gyeonggi-do, 16995, South Korea

RECRUITING

Related Publications (8)

• Alexander NB. Differential diagnosis of gait disorders in older adults. Clin Geriatr Med. 1996 Nov;12(4):689-703.

  PMID: 8890111 BACKGROUND

• Tinetti ME. Clinical practice. Preventing falls in elderly persons. N Engl J Med. 2003 Jan 2;348(1):42-9. doi: 10.1056/NEJMcp020719. No abstract available.

  PMID: 12510042 BACKGROUND

• Bennett DA, Beckett LA, Murray AM, Shannon KM, Goetz CG, Pilgrim DM, Evans DA. Prevalence of parkinsonian signs and associated mortality in a community population of older people. N Engl J Med. 1996 Jan 11;334(2):71-6. doi: 10.1056/NEJM199601113340202.

  PMID: 8531961 BACKGROUND

• Salzman B. Gait and balance disorders in older adults. Am Fam Physician. 2010 Jul 1;82(1):61-8.

  PMID: 20590073 BACKGROUND

• Verghese J, LeValley A, Hall CB, Katz MJ, Ambrose AF, Lipton RB. Epidemiology of gait disorders in community-residing older adults. J Am Geriatr Soc. 2006 Feb;54(2):255-61. doi: 10.1111/j.1532-5415.2005.00580.x.

  PMID: 16460376 BACKGROUND

• Fortin C, Feldman DE, Cheriet F, Labelle H. Clinical methods for quantifying body segment posture: a literature review. Disabil Rehabil. 2011;33(5):367-83. doi: 10.3109/09638288.2010.492066. Epub 2010 Jun 23.

  PMID: 20568973 BACKGROUND

• Kim H, Lee S, Lee D, Choi S, Ju J, Myung H. Real-time human pose estimation and gesture recognition from depth images using superpixels and SVM classifier. Sensors (Basel). 2015 May 26;15(6):12410-27. doi: 10.3390/s150612410.

  PMID: 26016921 BACKGROUND

• Chun MY. Validity and reliability of korean version of international physical activity questionnaire short form in the elderly. Korean J Fam Med. 2012 May;33(3):144-51. doi: 10.4082/kjfm.2012.33.3.144. Epub 2012 May 24.

  PMID: 22787536 BACKGROUND

MeSH Terms

Conditions

Gait Disorders, Neurologic; Nervous System Diseases

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Na Young Kim, MD, PhD

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Na Young Kim, MD, PhD

CONTACT

+82 010 9127 4482; kny8452@yuhs.ac

Seung Ick Choi

CONTACT

+82 010 8821 5297; rehab1@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study aims to explore the usefulness of collected data and does not establish a control group. Patients with subjective gait and balance disorders will wear insole-type gait analyzer and walk, then the collected data will be examined."

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: June 5, 2024
• Study Start: June 1, 2021
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)