None listed
Conditions
Interventions
Medical Device : Both groups perform rehabilitation exercise with the same duration and frequency: 3 times per week for 30–50 minutes per session over 12 weeks. However, the two groups differ in the f
adherence is only checked
Sponsors
SYM Heathcare Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age between 18 and 64 years (inclusive) at the time of written consent, in accordance with the "Unified Age Law" (amendments to the Administrative Basic Act and the Civil Act). 2) Individuals who have experienced knee pain for at least one month during the past 12 months, and meet at least one of the following criteria as confirmed by a medical professional: - Presence of tenderness in the knee area. - Observation of swelling in the knee joint. - Confirmation of increased joint effusion. 3) Smartphone users capable of linking/integrating with the 4DEYE DTx application. 4) Individuals judged by the investigator to have no difficulty in using the devices (smartphone and application). 5) Individuals who have received a full explanation of the clinical trial and voluntarily provided written informed consent to participate.
Exclusion criteria
Exclusion criteria: 1) Individuals previously diagnosed with rheumatoid arthritis. 2) Individuals who have undergone knee surgery within the last 3 months. 3) Individuals who have sustained a knee injury within the last 3 months. 4) Individuals who have received other investigational medicinal products (or medical devices) or undergone procedures within 4 weeks prior to the screening visit. 5) Individuals unable to cooperate due to mental illness, drug/substance abuse, or other related conditions. 6) Pregnant women. 7) Individuals judged by the investigator to be unsuitable for participation in this clinical trial for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in KOOS-PAIN score at 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in Visual Analogue Scale (VAS) score at 12 weeks;Change from baseline in Knee injury and Osteoarthritis Outcome Score-12 (KOOS-12) at 12 weeks;Change from baseline in Active Range of Motion (AROM) at 12 weeks;Change from baseline in rescue medication use at weeks 4, 8, and 12 | — |
Countries
Korea, Republic of
Contacts
Public ContactBYEONGHUN LEE
Gachon University Gil Medical Center
Outcome results
None listed