Active — Not RecruitingNot Applicable

Ankle Instability Using Foot Intensive Rehabilitation

United States150 participantsStarted 2021-10-28

Plain-language summary

The overall objective of this study is to examine the effects of a 6-week foot-intensive rehabilitation (FIRE) program on lateral ankle sprain (LAS) re-injury rates, CAI symptoms, sensorimotor function, and self-reported disability in CAI patients.

Who can participate

Age range18 Years – 44 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Aged 18-44.
✓. Previous history of at least 1 ankle sprain and at least 2 episodes of "giving way" in the past 3 months.
✓. Participants must answer "yes" to at least 5 questions on the Ankle Instability Instrument.
✓. Score of 11 or higher on the Identification of Functional Ankle Instability (IdFAI).
✓. Confirmed clinical presentation of CAI by a PT, AT, or MD.

Exclusion criteria

✕. Sustained an ankle sprain in the previous four weeks or lower extremity neuromusculoskeletal injury other than to the ankle in the last 12 months.
✕. History of surgery to the lower extremity.
✕. Sustained a lower extremity fracture.
✕. History of neurological disease, vestibular or visual disturbance or any other pathology that would impair their sensorimotor performance.
✕. Current participation in a formal ankle joint rehabilitation program.
✕. Sustained a concussion in the last 12 months.
✕. Exhibit clinical examination characteristics of foot and ankle function which are consistent with conditions other than CAI (i.e. fracture, deformity).

What they're measuring

Number of recurrent ankle sprains

Timeframe: 24 months

Frequency of episodes of the ankle giving way

Timeframe: 24 months

Severity of chronic ankle instability related symptoms

Timeframe: 24 months

Trial details

NCT IDNCT04493645

SponsorMatthew Hoch

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-01

View on ClinicalTrials.gov More Ankle Injuries trials

Who can participate

Age range18 Years – 44 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Aged 18-44.
✓. Previous history of at least 1 ankle sprain and at least 2 episodes of "giving way" in the past 3 months.
✓. Participants must answer "yes" to at least 5 questions on the Ankle Instability Instrument.
✓. Score of 11 or higher on the Identification of Functional Ankle Instability (IdFAI).
✓. Confirmed clinical presentation of CAI by a PT, AT, or MD.

Exclusion criteria

✕. Sustained an ankle sprain in the previous four weeks or lower extremity neuromusculoskeletal injury other than to the ankle in the last 12 months.
✕. History of surgery to the lower extremity.
✕. Sustained a lower extremity fracture.
✕. History of neurological disease, vestibular or visual disturbance or any other pathology that would impair their sensorimotor performance.
✕. Current participation in a formal ankle joint rehabilitation program.
✕. Sustained a concussion in the last 12 months.
✕. Exhibit clinical examination characteristics of foot and ankle function which are consistent with conditions other than CAI (i.e. fracture, deformity).