NCT04999904 · Henry M. Jackson Foundation for the Advancement of Military Medicine
A Proprioceptive Training Program Using an Uneven Terrain Treadmill for Patients With Ankle Instability
(ROCKY REHAB)
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
Uneven Treadmill Intervention
Progressive 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.
OTHER
Standard of Care Physical Therapy
Standard of Care Physical Therapy
Primary outcome measures
Change in the Cumberland Ankle Instability Tool
Time frame: Baseline assessment (0 weeks), first ( 2 weeks) and second (4 weeks) interim assessments, discharge assessment (6 weeks) and follow-up assessments at 3, 6, 9, 12, 15, and 18 months.
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
Time frame: Baseline assessment (0 weeks), first ( 2 weeks) and second (4 weeks) interim assessments, discharge assessment (6 weeks) and follow-up assessments at 3, 6, 9, 12, 15, and 18 months.
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
Time frame: Baseline assessment (0 weeks), first ( 2 weeks) and second (4 weeks) interim assessments, discharge assessment (6 weeks) and follow-up assessments at 3, 6, 9, 12, 15, and 18 months.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
- Passed most recent physical fitness test (Active duty only).
- Acute lateral ankle sprain specific inclusion criteria:
- history of a first-time ankle sprain that resulted in activity limitation that lasted at least one day.
- chronicity of 2-6 weeks prior to consent.
- Chronic ankle instability specific inclusion criteria:
- history of at least one significant ankle sprain within the 12 months prior to enrollment that interrupted physical activity for 1+ days.
- most recent ankle sprain in the past 2-12 weeks.
- history of the previously injured ankle joint "giving way" and/or recurrent sprain and/or ''feelings of instability.''
- Individual is about to start care with physical therapy.
Exclusion criteria
- 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.
- 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.
- Self-reported disability due to neuromuscular impairment in the lower extremity, neurological or vestibular impairment that affected balance.
- Connective tissue disorder (e.g. Marfan Syndrome or Ehlers-Danlos syndrome).
- 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
- Oceanside, California
- San Diego, California
Collaborators
United States Naval Medical Center, San Diego, Fort Sam Houston, Naval Hospital Camp Pendleton, Naval Health Research Center, VA Puget Sound Health Care System
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 18, 2025 · Source of record for eligibility and locations