A Proprioceptive Training Program Using an Uneven Terrain Treadmill for Patients With Ankle Insta… (NCT04999904) | Clinical Trial Compass
RecruitingNot Applicable
A Proprioceptive Training Program Using an Uneven Terrain Treadmill for Patients With Ankle Instability
United States312 participantsStarted 2021-11-23
Plain-language 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 improve outcomes and reduce reinjury rates in patients with ankle instability.
Who can participate
Age range
18 Years – 49 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in the Cumberland Ankle Instability Tool
Timeframe: 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.
2
Change in the Foot and Ankle Ability Measure, Activities of Daily Living Subscale
Timeframe: 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.
3
Change in the Foot and Ankle Ability Measure, Sports Subscale
Timeframe: 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.
Trial details
NCT IDNCT04999904
SponsorHenry M. Jackson Foundation for the Advancement of Military Medicine
. 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.
. Pregnant.
. 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).