NCT04999904 A Proprioceptive Training Program Using an Uneven Terrain Treadmill for Patients With Ankle Instability
| NCT ID | NCT04999904 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Henry M. Jackson Foundation for the Advancement of Military Medicine |
| Condition | Instability; Ankle (Ligaments) (Old Injury) |
| Study Type | INTERVENTIONAL |
| Enrollment | 312 participants |
| Start Date | 2021-11-23 |
| Primary Completion | 2025-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 312 participants in total. It began in 2021-11-23 with a primary completion date of 2025-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria 1. Aged 18-49. 2. Score \< 24 on the Cumberland Ankle Instability Tool. 3. Foot and Ankle Ability Measure Activities of Daily Living score ≤ 90 and Sports score ≤ 80 indicating substantial ankle-foot impairment and activity limitation. 4. Able to attend treatment sessions for approximately a 6-week period. 5. Passed most recent physical fitness test (Active duty only). 6. Acute lateral ankle sprain specific inclusion criteria: 1. history of a first-time ankle sprain that resulted in activity limitation that lasted at least one day. 2. chronicity of 2-6 weeks prior to consent. 7. Chronic ankle instability specific inclusion criteria: 1. history of at least one significant ankle sprain within the 12 months prior to enrollment that interrupted physical activity for 1+ days. 2. most recent ankle sprain in the past 2-12 weeks. 3. history of the previously injured ankle joint "giving way" and/or recurrent sprain and/or ''feelings of instability.'' 8. Individual is about to start care with physical therapy. Exclusion Criteria 1. Unable to walk at the point of study enrollment. 2. Non-removable casting. 3. History of previous surgeries to the musculoskeletal structures (i.e., bones, joint structures, nerves). 4. History of fracture in either limb of the lower extremity requiring realignment. 5. 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. 6. Pregnant. 7. Self-reported disability due to neuromuscular impairment in the lower extremity, neurological or vestibular impairment that affected balance. 8. Connective tissue disorder (e.g. Marfan Syndrome or Ehlers-Danlos syndrome). 9. 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.
Contact & Investigator
Pinata Sessoms, PhD
PRINCIPAL INVESTIGATOR
Naval Health Research Center
Frequently Asked Questions
Who can join the NCT04999904 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 49 Years, studying Instability; Ankle (Ligaments) (Old Injury). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04999904 currently recruiting?
Yes, NCT04999904 is actively recruiting participants. Contact the research team at Pinata.h.sessoms.civ@health.mil for enrollment information.
Where is the NCT04999904 trial being conducted?
This trial is being conducted at Oceanside, United States, San Diego, United States.
Who is sponsoring the NCT04999904 clinical trial?
NCT04999904 is sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine. The principal investigator is Pinata Sessoms, PhD at Naval Health Research Center. The trial plans to enroll 312 participants.