New treatment option for Instability; Ankle (Ligaments) (Old Injury)
Official title A Proprioceptive Training Program Using an Uneven Terrain Treadmill for Patients With Ankle Instability
ClinicalTrials.gov ID: NCT04999904
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 49
You may be able to join if
- 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...
- Able to attend treatment sessions for approximately a 6-week period.
- Passed most recent physical fitness test (Active duty only).
You likely can't join if
- 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...
- Pregnant.
See the full eligibility 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
- 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
- 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.
- 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...
- 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).
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Oceanside, California, United States
- San Diego, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 49 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Oceanside, California, United States; San Diego, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.