Status:

RECRUITING

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

Lead Sponsor:

Henry M. Jackson Foundation for the Advancement of Military Medicine

Collaborating Sponsors:

United States Naval Medical Center, San Diego

Fort Sam Houston

Conditions:

Instability; Ankle (Ligaments) (Old Injury)

Sprain of Ankle

Eligibility:

All Genders

18-49 years

Phase:

NA

Brief Summary

The ROCKY REHAB trial will provide a pragmatic approach to evaluate if incorporating a rocky, uneven terrain treadmill into the proprioceptive rehabilitation received during physical therapy can impro...

Detailed Description

Lower limb sprains and strains are three-times more prevalent than any other acute injury in the Armed Forces, with lateral ankle sprains being the most common injury sustained during active-duty. Man...

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.

Key Trial Info

Start Date :

November 23 2021

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 30 2026

Estimated Enrollment :

312 Patients enrolled

Trial Details

Trial ID

NCT04999904

Start Date

November 23 2021

End Date

September 30 2026

Last Update

July 18 2025

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Naval Hospital Camp Pendelton

Oceanside, California, United States, 92055

2

Naval Medical Center San Diego

San Diego, California, United States, 92134