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

Gait Disorders, Neurologic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06442982
• Other study ID #: 9-2021-0055
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: May 1, 2025

Study information

• Verified date: June 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: May 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Nervous System Diseases

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (8)

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.; 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.; 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.
Primary	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.
Primary	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.