Clinical trial NCT05905029: Establishment of Biomechanical- and AI- Based Rehabilitation Strategies for Pain Inducing Lifestyles
Official title: Establishment of Biomechanical-based Rehabilitation Strategies for Pain-inducing Lifestyles in Degenerative Knee/Back Patients and for Artificial Intelligence-based Rehabilitation System
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Healthy
Degenerative Disease
Lead sponsor: Bundang CHA Hospital
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy subjects and patients who complain pain by degenerative changes in knee or back

Brief 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.

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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Motion analysis
timeFrame: 1 day after screening assessment
Secondary outcomes:
measure: Ground reaction force
timeFrame: 1 day after screening assessment
measure: EMG measurement
timeFrame: 1 day after screening assessment
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Department of Rehabilitation Medicine, CHA Bundang Medical Center
city: Seongnam
country: Korea, Republic of
facility: Department of Rehabilitation Medicine, CHA Bundang Medical Center
Study officials:
affiliation: Bundang CHA Hospital
name: Minyoung Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: