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 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT04314960
Eligibility Criteria:
Inclusion Criteria:
1. A history of at least one significant ankle sprain:
1. At least 12 months prior to participating in the study
2. Was characterized by inflammatory symptoms (i.e. pain and swelling)
3. Caused at least one day of decreased physical activity
2. At least 3 months since the last acute ankle sprain that results in inflammatory symptoms and at least one interrupted day of desired physical activity.
3. History of the previously injured ankle 'giving way' at least twice during the last 6 months, and/or 'feelings of instability' and/or recurrent sprain.
4. Being able to bear full weight on the injured lower extremity with no more than mild discomfort.
5. Scoring\<24 in the Cumberland Ankle Instability Tool (CAIT)
Exclusion Criteria:
1. A history of previous surgeries to a musculoskeletal structure in either lower limb.
2. A history of a fracture requiring re-alignment
3. Any acute injury to a lower limb in the last 3 months.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT04314960
Study Brief:
Protocol Section:
NCT04314960