Recruiting

Proprioceptive Training

Sponsor:

Henry M. Jackson Foundation for the Advancement of Military Medicine

Code:

NCT04999904

Conditions

Instability; Ankle (Ligaments) (Old Injury)

Sprain of Ankle

Eligibility Criteria

Sex: All

Age: 18 - 49

Healthy Volunteers: Not accepted

Interventions

Uneven Treadmill Intervention

Standard of Care Physical Therapy

Study Details

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.

Conditions

Instability; Ankle (Ligaments) (Old Injury)

Sprain of Ankle

Study ID

NCT04999904

Start date

Nov 23, 2021

Status verified date

Jul, 2025

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Sep 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 49

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

312 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Uneven Treadmill Arm

Uneven Treadmill Intervention with up to twelve sessions over approximately six weeks and Standard of Care Physical Therapy with an 18 month follow-up period

active comparator: Control Arm

Standard of Care Physical Therapy over approximately six weeks with an 18 month follow-up period

Interventions

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.

Standard of Care Physical Therapy

Standard of Care Physical Therapy

Primary outcome measure

  • 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. ]
  • 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. ]
  • 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. ]

Central Contacts and Locations

Locations

Naval Hospital Camp Pendelton

Recruiting

Oceanside, California, United States, 92055

Contacts

Naval Medical Center San Diego

Recruiting

San Diego, California, United States, 92134

Contacts

Emma Beisheim-Ryan, PT, DPT, PhD

585-975-9644emma.h.beisheim-ryan.civ@health.mil

Principal Investigator:

Emma Beisheim-Ryan, PT, DPT, PhD

More Information

Sponsor

Henry M. Jackson Foundation for the Advancement of Military Medicine

Last update posted

Jul 18, 2025

Last verified

Jul, 2025

Keywords

  • Acute Ankle Sprain
  • Chronic Ankle Instability
  • Proprioceptive Training
  • Uneven Treadmill
  • Reinjury
  • Rehabilitation
  • Service Members

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Henry M. Jackson Foundation for the Advancement of Military Medicine on 2025-07-18.