Proprioceptive training with a rocky, uneven-terrain treadmill for ankle instability

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial randomly assigns 312 adults aged 18-49 with acute or chronic lateral ankle instability to standard physical therapy or to the same therapy supplemented with sessions on a rocky, uneven-terrain treadmill. Researchers will collect patient-reported outcomes, clinical performance tests, and biomechanical measures such as muscle activation and plantar pressures before, during, and after the roughly 6-week intervention. Re-injury rates and patient-reported outcomes will be followed for 18 months to capture both short- and long-term effects. The pragmatic protocol is conducted at military medical centers and is intended to better replicate real-world walking challenges patients face after finishing therapy.

Why it matters

Who can join: the full rules

Inclusion Criteria

1. Aged 18-49.
2. Score \< 24 on the Cumberland Ankle Instability Tool.
3. Foot and Ankle Ability Measure Activities of Daily Living score ≤ 90 and Sports score ≤ 80 indicating substantial ankle-foot impairment and activity limitation.
4. Able to attend treatment sessions for approximately a 6-week period.
5. Passed most recent physical fitness test (Active duty only).
6. Acute lateral ankle sprain specific inclusion criteria:

   1. history of a first-time ankle sprain that resulted in activity limitation that lasted at least one day.
   2. chronicity of 2-6 weeks prior to consent.
7. Chronic ankle instability specific inclusion criteria:

   1. history of at least one significant ankle sprain within the 12 months prior to enrollment that interrupted physical activity for 1+ days.
   2. most recent ankle sprain in the past 2-12 weeks.
   3. history of the previously injured ankle joint "giving way" and/or recurrent sprain and/or ''feelings of instability.''
8. Individual is about to start care with physical therapy.

Exclusion Criteria

1. Unable to walk at the point of study enrollment.
2. Non-removable casting.
3. History of previous surgeries to the musculoskeletal structures (i.e., bones, joint structures, nerves).
4. History of fracture in either limb of the lower extremity requiring realignment.
5. Acute injury to musculoskeletal structures of other joints of the lower extremity within the previous three months, which impacted joint integrity and function resulting in at least one interrupted day of physical activity.
6. Pregnant.
7. Self-reported disability due to neuromuscular impairment in the lower extremity, neurological or vestibular impairment that affected balance.
8. Connective tissue disorder (e.g. Marfan Syndrome or Ehlers-Danlos syndrome).
9. Anyone separating from the military within 12 months (other than normal military retirement), pending a medical evaluation board, discharge from the military for medical reasons, or pending or undergoing any litigation for an injury.

Where it's running

• Naval Hospital Camp Pendelton
  Oceanside, California, United States Recruiting
• Naval Medical Center San Diego
  San Diego, California, United States Recruiting

Study contacts

• Principal investigator: Pinata Sessoms, PhD — Naval Health Research Center
• Study coordinator: Pinata Sessoms, PhD
• Email: Pinata.h.sessoms.civ@health.mil
• Phone: 619-553-7760

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.