NCT05905029

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

August 4, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

1.6 years

First QC Date

May 29, 2023

Last Update Submit

November 15, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Motion analysis

    Motion capture analysis for kinetic and kinematic data

    1 day after screening assessment

Secondary Outcomes (2)

  • Ground reaction force

    1 day after screening assessment

  • EMG measurement

    1 day after screening assessment

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy subjects and patients who complain pain by degenerative changes in knee or back

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • 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 back
  • Over 19 years of age
  • Those with a back pain rating scale (VAS) of '1' or higher
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Rehabilitation Medicine, CHA Bundang Medical Center

Seongnam, 13496, South Korea

RECRUITING

Department of Rehabilitation Medicine, CHA Bundang Medical Center

Seongnam, 13496, South Korea

NOT YET RECRUITING

Study Officials

  • Minyoung Kim, M.D., Ph.D.

    Bundang CHA Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyun Jung Oh, Bachelor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

May 29, 2023

First Posted

June 15, 2023

Study Start

August 4, 2023

Primary Completion

February 28, 2025

Study Completion

February 28, 2025

Last Updated

November 18, 2023

Record last verified: 2023-11

Locations