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 improve outcomes and reduce reinjury rates in patients with ankle instability.
Aged 18-49.
Score < 24 on the Cumberland Ankle Instability Tool.
Foot and Ankle Ability Measure Activities of Daily Living score ≤ 90 and Sports score ≤ 80 indicating substantial ankle-foot impairment and activity limitation.
Able to attend treatment sessions for approximately a 6-week period.
Unable to walk at the point of study enrollment.
Non-removable casting.
History of previous surgeries to the musculoskeletal structures (i.e., bones, joint structures, nerves).
History of fracture in either limb of the lower extremity requiring realignment.
Parallel
Uneven Treadmill Intervention
Other interventionProgressive proprioceptive training on the uneven treadmill with up to twelve training sessions. Subjects will be advanced through activities with progression pragmatically assessed by the physical therapists for the benefit and tolerance of the individual subject. Activities may include: slow walking, fast walking, inclined/declined walking, head turning, vision obstruction, dual task walking, fatigued walking, load carriage. Standard of care physical therapy is still provided.
Standard of Care Physical Therapy
Other interventionStandard of Care Physical Therapy
Change in the Cumberland Ankle Instability Tool
The Cumberland Ankle Instability Tool is a 9-item questionnaire, 30 points max score, with higher scores indicating better function. The Cumberland Ankle Instability Tool evaluates the severity of ankle instability during sport and activities of daily living, as well as pain.
Change in the Foot and Ankle Ability Measure, Activities of Daily Living Subscale
The Foot and Ankle Ability Measure: Activities of Daily Living subscale is a 21-item questionnaire with 84 points max, with higher scores indicating better function. The Activities of Daily Living Subscale is used to assess activity limitations and restrictions for individuals with foot and ankle disorders, including ankle sprains, during activities of daily living.
Change in the Foot and Ankle Ability Measure, Sports Subscale
The Foot and Ankle Ability Measure: Sports subscale is a 8-item questionnaire with 32 points max, with higher scores indicating better function. The Sports Subscale is used to assess activity limitations and restrictions for individuals with foot and ankle disorders, including ankle sprains, during recreational/sport activities.
Change in the Lower Extremity Functional Scale
The Lower Extremity Functional Scale is a 20-item questionnaire with 80 points max, with higher scores indicating better function. The Lower Extremity Functional Scale is used for individuals with lower extremity musculoskeletal disorders and assesses activity limitations and participation restrictions.
Change in the Tampa Scale of Kinesiophobia
The Tampa Scale of Kinesiophobia is a 11-item questionnaire with scores between 11 and 44 points, with higher scores indicating greater kinesiophobia. The Tampa Scale of Kinesiophobia is used to assess subjective ratings of fear-related concepts.
Change in the Numeric Pain Rating Scale
The Numeric Pain Rating Scale is a 4-item questionnaire with scores between 0 and 40 points, with higher scores indicating greater pain. In the Numeric Pain Rating Scale subjects select a value that is most in line with the intensity of pain they have experienced in the past 24 hours.
Change in the Godin Leisure-Time Physical Activity Questionnaire
The Godin Leisure-Time Physical Activity Questionnaire measures the number of instances where subjects engaged in mild, moderate, and strenuous physical activity for greater than 15 minutes. Modified to account over the previous week rather than a typical week. Higher scores indicate more physical activity where 3, 5, and 9 points are given for each time a mild, moderate, or strenuous activity is engaged.
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Henry M. Jackson Foundation for the Advancement of Military Medicine
Lead sponsor
United States Naval Medical Center, San Diego
Collaborator
Fort Sam Houston
Collaborator
Naval Hospital Camp Pendleton
Collaborator
Naval Health Research Center
Collaborator
VA Puget Sound Health Care System
Collaborator
