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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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." |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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.
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Na Young Kim, MD, PhD | Contact | +82 010 9127 4482 | kny8452@yuhs.ac | |
| Seung Ick Choi | Contact | +82 010 8821 5297 | rehab1@yuhs.ac |
| Name | Affiliation | Role |
|---|---|---|
| Na Young Kim, MD, PhD | Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yongin Severance Hospital | Recruiting | Yongin-si | Gyeonggi-do | 16995 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8890111 | Background | Alexander NB. Differential diagnosis of gait disorders in older adults. Clin Geriatr Med. 1996 Nov;12(4):689-703. | |
| 12510042 | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 4, 2025 | Feb 4, 2025 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D020233 | Gait Disorders, Neurologic |
| D009422 | Nervous System Diseases |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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."
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| 8531961 | 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. |
| 20590073 | Background | Salzman B. Gait and balance disorders in older adults. Am Fam Physician. 2010 Jul 1;82(1):61-8. |
| 16460376 | 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. |
| 20568973 | 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. |
| 26016921 | 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. |
| 22787536 | 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. |