Clinical trial NCT06442982: Analyzing Gait Pattern Using Insole-type Gait Analyzer in Patient With Gait Disturbance
Official title: Usefulness of Insole-type Gait Analyzer in Collecting Gait Data From Patients With Gait Disturbance
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gait Disorders, Neurologic
Keywords: gait analysis
smart insole
neurologic disorder
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2024-06-05
Enrollment: 600
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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."
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Timed up and go test (TUG)
timeFrame: TUG test session will last approximately 5 minutes. and TUG test will be performed at baseline.
measure: Korean version of Sarcopenia Screening Questionnaire
timeFrame: This K-SSQ session will last approximately 1 minutes, it will be performed at baseline.
measure: Korean version of the International Physical Activity Questionnaire (K-IPAQ)
timeFrame: This K-IPAQ session will last approximately 3 minutes, it will be performed at baseline.
Secondary outcomes:
Other outcomes:
Locations:
city: Yongin-si
country: Korea, Republic of
facility: Yongin Severance Hospital
state: Gyeonggi-do
Study officials:
affiliation: Severance Hospital
name: Na Young Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alexander NB. Differential diagnosis of gait disorders in older adults. Clin Geriatr Med. 1996 Nov;12(4):689-703.
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.
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.
citation: Salzman B. Gait and balance disorders in older adults. Am Fam Physician. 2010 Jul 1;82(1):61-8.
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.
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.
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.
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.