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:
2025-12-24 @ 6:57 PM
Ignite Modification Date:
2025-12-24 @ 6:57 PM
NCT ID:
NCT01541657
Eligibility Criteria:
Inclusion Criteria:
1. Male or female 18-45 years of age
2. History of ankle sprain with at least two episodes of "giving way" within the past six months
3. Score of ≥ 5 on the Ankle Instability Instrument (AII)
4. Score of ≤ 90% on the Foot and Ankle Ability Measure (FAAM)- Activity of Daily Living (ADL) Subscale
5. Score of ≤ 80% on the FAAM-Sport Subscale.
Exclusion Criteria:
1. Younger than 18 or older than 45 years
2. No history of ankle sprain or episodes of "giving way" in the past six months
3. Score of ≤ 5 on the Ankle Instability Instrument (AII)
4. Score of ≥ 90% on the FAAM-ADL
5. Score of ≥ 80% on the FAAM-S.
6. An acute ankle sprain within the past 6 weeks.
7. Previous history of lower extremity surgery with internal derangements, reconstructions, or repair
8. Lower extremity injury within the past 6 months (other than ankle sprains)
9. Presence of balance deficits or conditions known to affect balance as noted on the Balance Questionnaire including diabetes and/or vertigo.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT01541657
Study Brief:
Protocol Section:
NCT01541657