Gait Disorders, NeurologicNCT06442982
Analyzing Gait Pattern Using Insole-type Gait Analyzer in Patient With Gait Disturbance
A study testing insole-type gait analyzer in people with Gait Disorders, Neurologic, run by Yonsei University at 1 site in South Korea.
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?… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Gait Disorders, Neurologic
- What is being tested?
- insole-type gait analyzer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2021to 31 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Yongin Severance Hospital
Yongin-si, Gyeonggi-do, 16995
Na Young Kim, +82 010 9127 4482, kny8452@yuhs.ac
Seung Ick Choi, +82 010 8821 5297, rehab1@yuhs.ac
About this study
Official title: 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.
Read the 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.
- Conditions
- Gait Disorders, Neurologic
- Being tested
- insole-type gait analyzer
- Keywords
- gait analysis, smart insole, neurologic disorder
- Medical subject headings
- Gait Disorders, Neurologic, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insole-type gait analyzerDevice
Patients with subjective gait and balance disorders will wear insole-type gait analyzer and walk, then the collected data will be examined.
| Study group | Role | What they receive |
|---|---|---|
| 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." Receives: Device: insole-type gait analyzer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- 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.
Measured: 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.
Measured: 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'.
Measured: This K-IPAQ session will last approximately 3 minutes, it will be performed at baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start1 Jun 2021
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Gait Disorders, NeurologicStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- 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."
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Na Young Kim, MD, PhD, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06442982
- Sponsor's protocol ID
- 9-2021-0055
- Status last verified
- Feb 2025
- First submitted
- 21 May 2024
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alexander NB. Differential diagnosis of gait disorders in older adults. Clin Geriatr Med. 1996 Nov;12(4):689-703.
PubMed 8890111Tinetti 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.
PubMed 12510042Bennett 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.
PubMed 8531961Salzman B. Gait and balance disorders in older adults. Am Fam Physician. 2010 Jul 1;82(1):61-8.
PubMed 20590073Verghese 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.
PubMed 16460376Fortin 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.
PubMed 20568973Kim 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.
PubMed 26016921Chun 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.
PubMed 22787536
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Insole-type Gait Analyzer in Collecting Gait Data From Patients With Gait Disturbance
- ClinicalTrials.gov ID
- NCT06442982
- Acronym / sponsor ID
- 9-2021-0055
- Conditions
- Gait Disorders, Neurologic
- Keywords
- gait analysis, smart insole, neurologic disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 5 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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."
| Arm | Type | Receives |
|---|---|---|
| Insole wearing group | Experimental | Device: insole-type gait analyzerPatients with subjective gait and balance disorders will wear insole-type gait analyzer and walk, then the collected data will be examined." |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| insole-type gait analyzerPatients with subjective gait and balance disorders will wear insole-type gait analyzer and walk, then the collected data will be examined. | Device | Insole wearing group |
Primary outcome
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.
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.
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'.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Background: PubMed 8890111Alexander NB. Differential diagnosis of gait disorders in older adults. Clin Geriatr Med. 1996 Nov;12(4):689-703.
- Background: PubMed 12510042Tinetti 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.
- Background: PubMed 8531961Bennett 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.
- Background: PubMed 20590073Salzman B. Gait and balance disorders in older adults. Am Fam Physician. 2010 Jul 1;82(1):61-8.
- Background: PubMed 16460376Verghese 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.
- Background: PubMed 20568973Fortin 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.
- Background: PubMed 26016921Kim 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.
- Background: PubMed 22787536Chun 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Na Young Kim, MD, PhD principal investigator
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing insole-type gait analyzer in people with Gait Disorders, Neurologic, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Na Young Kim, MD, PhD (+82 010 9127 4482, kny8452@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06442982, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.