HealthyNCT05905029
Establishment of Biomechanical- and AI- Based Rehabilitation Strategies for Pain Inducing Lifestyles
An observational study of Healthy and Degenerative Disease, run by Bundang CHA Hospital at 2 sites in South Korea.
Trial summary
To develop biomechanical indicators for pain-inducing lifestyles and apply lifestyle strategies for patients and confirm their effectiveness to be used in artificial intelligence-based digital treatment devices. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, Degenerative Disease
- How many people
- 100 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 4 Aug 2023to 28 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy subjects and patients who complain pain by degenerative changes in knee or back
Who may be able to join
- Over 19 years of age
- Those who scored '0' on the Knee/Back Pain Assessment Scale (VAS)
- After hearing a detailed explanation of this study and fully understanding it, the subject or legal representative voluntarily decides to participate and agrees in writing to observe the precautions
- Over 19 years of age
- Those who scored '1' or higher on the Knee Pain Assessment Scale (VAS)
- After hearing a detailed explanation of this study and fully understanding it, the subject or legal representative voluntarily decides to participate and agrees in writing to observe the precautions
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- Over 19 years of age
- Those with a back pain rating scale (VAS) of '1' or higher
- After hearing a detailed explanation of this study and fully understanding it, the subject or legal representative voluntarily decides to participate and agrees in writing to observe the precautions
Who cannot join
- Patients who correspond to one or more of the following cannot participate in the study.
- Those with systemic infectious symptoms at the time of participation in the study
- Persons with poor systemic conditions such as unstable conditions of the cardiovascular system, digestive system, respiratory system, endocrine system, etc., and those with cerebrovascular disease
- Other cases where the researcher judges that participation in this study is not suitable (Patients who are participating in other studies or who have participated in other studies within the past 30 days can also participate in this study.)
- Subjects who complain pain by degenrative changes in knee
- Patients who correspond to one or more of the following cannot participate in the study.
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- Those with systemic infectious symptoms at the time of participation in the study
- Persons with poor systemic conditions such as unstable conditions of the cardiovascular system, digestive system, respiratory system, endocrine system, etc., and those with cerebrovascular disease
- Other cases where the researcher judges that participation in this study is not suitable (Patients who are participating in other studies or who have participated in other studies within the past 30 days can also participate in this study.)
- Subjects who complain pain by degenrative changes in back
- Patients who correspond to one or more of the following cannot participate in the study.
- Those with systemic infectious symptoms at the time of participation in the study
- Persons with poor systemic conditions such as unstable conditions of the cardiovascular system, digestive system, respiratory system, endocrine system, etc., and those with cerebrovascular disease
- Other cases where the researcher judges that participation in this study is not suitable (Patients who are participating in other studies or who have participated in other studies within the past 30 days can also participate in this study.)
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites, 2 recruiting
- Recruiting
Department of Rehabilitation Medicine, CHA Bundang Medical Center
Seongnam, 13496
MinYoung Kim, MD,PhD
- Not yet recruiting
Department of Rehabilitation Medicine, CHA Bundang Medical Center
Seongnam, 13496
Hyun Jung Oh, Bachelor, +82 031 780 6003 ext. 6003, a210525@chamc.co.kr
About this study
Official title: Establishment of Biomechanical-based Rehabilitation Strategies for Pain-inducing Lifestyles in Degenerative Knee/Back Patients and for Artificial Intelligence-based Rehabilitation System
To develop biomechanical indicators for pain-inducing lifestyles and apply lifestyle strategies for patients and confirm their effectiveness to be used in artificial intelligence-based digital treatment devices.
Read the detailed description
To develop biomechanical indicators for pain-inducing lifestyles and apply lifestyle strategies for patients and confirm their effectiveness to be used in artificial intelligence-based digital treatment devices for patients who complain degenerative knee and back pain.
- Conditions
- Healthy, Degenerative Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Motion analysis
Motion capture analysis for kinetic and kinematic data
Measured: 1 day after screening assessment
Secondary outcomes (2)
Ground reaction force
GRF measurement for ground reaction force in newtone
Measured: 1 day after screening assessment
EMG measurement
Electromyography in maximum voluntary contraction
Measured: 1 day after screening assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start4 Aug 2023
- Primary completion28 Feb 2025 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bundang CHA Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MinYoung Kim, MD, PhD, Bundang CHA Hospital
- Investigators
- Minyoung Kim, M.D., Ph.D., Principal investigator, Bundang CHA Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05905029
- Sponsor's protocol ID
- 2022-11-015
- Status last verified
- Nov 2023
- First submitted
- 29 May 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of Biomechanical-based Rehabilitation Strategies for Pain-inducing Lifestyles in Degenerative Knee/Back Patients and for Artificial Intelligence-based Rehabilitation System
- ClinicalTrials.gov ID
- NCT05905029
- Acronym / sponsor ID
- 2022-11-015
- Conditions
- Healthy, Degenerative Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Bundang CHA HospitalUniversity, hospital or other
- Study start
- 4 Aug 2023 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 15 Jun 2023 (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.
To develop biomechanical indicators for pain-inducing lifestyles and apply lifestyle strategies for patients and confirm their effectiveness to be used in artificial intelligence-based digital treatment devices.
Detailed description
To develop biomechanical indicators for pain-inducing lifestyles and apply lifestyle strategies for patients and confirm their effectiveness to be used in artificial intelligence-based digital treatment devices for patients who complain degenerative knee and back pain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy subjects and patients who complain pain by degenerative changes in knee or back
Key inclusion criteria (9 listed)
Key exclusion criteria (14 listed)
- Subjects who complain pain by degenrative changes in knee
- Subjects who complain pain by degenrative changes in back
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Motion analysis
Time frame: 1 day after screening assessment
Motion capture analysis for kinetic and kinematic data
2 secondary outcomes
Ground reaction force
Time frame: 1 day after screening assessment
EMG measurement
Time frame: 1 day after screening assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
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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. This study is not recruiting at the moment.
Minyoung Kim, M.D., Ph.D. principal investigator
Bundang CHA Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Degenerative Disease, run by Bundang CHA Hospital at 2 sites 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 9 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyun Jung Oh, Bachelor (+82 031 780 6003, a210525@chamc.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motion analysis (time frame: 1 day after screening assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2023.