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 range18 Years – 49 Years
SexALL
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.
✓. chronicity of 2-6 weeks prior to consent.
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.
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