Establishment of Biomechanical- and AI- Based Rehabilitation Strategies for Pain Inducing Lifestyles

Healthy Clinical Trial

Official title:

Establishment of Biomechanical-based Rehabilitation Strategies for Pain-inducing Lifestyles in Degenerative Knee/Back Patients and for Artificial Intelligence-based Rehabilitation System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05905029
• Other study ID #: 2022-11-015
• Status: Recruiting
• 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
• 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.)

Related Conditions & MeSH terms

• Degenerative Disease
• Healthy

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