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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05905029
Other study ID # 2022-11-015
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 4, 2023
Est. completion date February 28, 2025

Study information

Verified date November 2023
Source Bundang CHA Hospital
Contact Hyun Jung Oh, Bachelor
Phone +82 031 780 6003
Email a210525@chamc.co.kr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date February 28, 2025
Est. primary completion date February 28, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years and older
Eligibility 1. Normal subjects - Inclusion criteria 1. Over 19 years of age 2. Those who scored '0' on the Knee/Back Pain Assessment Scale (VAS) 3. 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 - Exclusion criteria 1. Patients who correspond to one or more of the following cannot participate in the study. 2. Those with systemic infectious symptoms at the time of participation in the study 3. 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 4. 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.) 2. Subjects who complain pain by degenrative changes in knee - Inclusion criteria 1. Over 19 years of age 2. Those who scored '1' or higher on the Knee Pain Assessment Scale (VAS) 3. 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 - Exclusion criteria 1. Patients who correspond to one or more of the following cannot participate in the study. 2. Those with systemic infectious symptoms at the time of participation in the study 3. 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 4. 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.) 3. Subjects who complain pain by degenrative changes in back - Inclusion criteria 1. Over 19 years of age 2. Those with a back pain rating scale (VAS) of '1' or higher 3. 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 - Exclusion criteria 1. Patients who correspond to one or more of the following cannot participate in the study. 2. Those with systemic infectious symptoms at the time of participation in the study 3. 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 4. 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.)

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Korea, Republic of Department of Rehabilitation Medicine, CHA Bundang Medical Center Seongnam
Korea, Republic of Department of Rehabilitation Medicine, CHA Bundang Medical Center Seongnam

Sponsors (1)

Lead Sponsor Collaborator
Bundang CHA Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Motion analysis Motion capture analysis for kinetic and kinematic data 1 day after screening assessment
Secondary Ground reaction force GRF measurement for ground reaction force in newtone 1 day after screening assessment
Secondary EMG measurement Electromyography in maximum voluntary contraction 1 day after screening assessment
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