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 @ 3:21 AM
Ignite Modification Date:
2025-12-25 @ 3:21 AM
NCT ID:
NCT06971705
Eligibility Criteria:
Inclusion Criteria:
1. Age 18-60 years.
2. History of at least one significant ankle sprain within the past 12 months, accompanied by inflammatory response (including pain resulting in at least one day of restricted physical activity).
3. The most recent ankle sprain must have occurred more than 3 months prior to enrollment.
4. Self-reported symptoms of ankle instability, defined by one or more of the following: At least two episodes of "giving way" in the affected ankle within the past 6 months; Recurrent sprains (≥2 documented sprains in the same ankle); Subjective perception of instability confirmed by any one of the following validated instruments: Ankle Instability Instrument (AII): ≥5 affirmative responses; Cumberland Ankle Instability Tool (CAIT): Score \<24; Identification of Functional Ankle Instability (IdFAI): Score \>11.
5. Foot and Ankle Ability Measure (FAAM): Activities of Daily Living (ADL) subscale \<90%; FAAM Sports subscale \<80%; Foot and Ankle Outcome Score (FAOS): Scores \<75% in ≥3 subcategories.
Exclusion Criteria:
1. Chronic ankle instability caused by bilateral ankle sprains;
2. History of lower extremity musculoskeletal or neurological surgery;
3. History of lower extremity fractures;
4. Acute musculoskeletal injuries in other lower extremity joints within 3 months that compromised joint integrity and function, resulting in ≥1 day of interrupted daily or sports activities;
5. Concomitant severe systemic diseases (cardiac, pulmonary, hepatic, renal, etc.);
6. Severe psychiatric disorders or cognitive impairments;
7. Presence of metal implants or inability to tolerate MRI examinations.
8. Patient refusal to participate.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT06971705
Study Brief:
Protocol Section:
NCT06971705