Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-25 @ 3:04 AM
NCT ID:
NCT06936033
Eligibility Criteria:
Inclusion Criteria:
* Subjects had experienced at least one acute sprain of the ankle joint.
* Those who experienced symptoms of pain and instability during daily activities or sports.
* No other serious diseases affecting the function of the lower limbs (e.g., arthritis, severe knee lesions, etc.).
* AOFAS \< 80 points and VAS ≤ 3 on the affected side.
* The onset of injury is usually limited to 7 days to ensure that it is in the acute phase.
* Participants maintained a steady level of daily activity during the study period.
Exclusion Criteria:
* History of severe structural injury or surgery to the ankle (e.g., ligament reconstruction surgery, arthroscopic surgery, etc.).
* Presence of neuromuscular disease, or women during pregnancy.
* Allergy to muscle patch materials or history of skin disease. Ankle-related surgery or rehabilitation within the last 6 months.
* Before the initiation of data collection, all participants provided their written informed consent.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Weeks
Maximum Age:
44 Weeks
Study:
NCT06936033
Study Brief:
Protocol Section:
NCT06936033