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

A Proprioceptive Training Program Using an Uneven Terrain Treadmill for Patients With Ankle Instability

This program will test whether adding a rocky, uneven-terrain treadmill to standard physical therapy helps people ages 18-49 with recent ankle sprains or chronic ankle instability recover better and have fewer re-injuries.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 312 (estimated)
• Ages: 18 Years to 49 Years
• Sex: All
• Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine (Academic / other)
• Locations: 2 sites (Oceanside, California and 1 other locations)
• Trial ID: NCT04999904 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults 18-49 with recent or recurrent lateral ankle sprains and measurable instability (low Cumberland Ankle Instability Tool and reduced Foot and Ankle Ability Measure scores) who can attend about six weeks of in-person therapy sessions.

Not a fit: People older than 49, those without measurable ankle instability, those unable to attend in-person therapy, or individuals with severe structural ankle damage or prior corrective ankle surgery may not benefit from this intervention.

Why it matters

Potential benefit: If successful, this approach could improve balance and function after ankle sprains and reduce the chance of future sprains.

How similar studies have performed: Proprioceptive training has been shown to improve outcomes and reduce re-injury after ankle sprains, but using an uneven-terrain treadmill to specifically 'train to task' is a newer and less-tested approach.

Eligibility criteria

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 this trial is running

Oceanside, California and 1 other locations

• 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

Conditions Instability; Ankle; Sprain of Ankle; Acute Ankle Sprain; Chronic Ankle Instability; Proprioceptive Training; Uneven Treadmill; Reinjury