A Proprioceptive Training Program Using an Uneven Terrain Treadmill for Patients With Ankle Instability

NCT04999904 | Recruiting

• 2 other identifiers: 937017W81XWH-20-2-0056
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Change in the Cumberland Ankle Instability Tool

  The Cumberland Ankle Instability Tool is a 9-item questionnaire, 30 points max score, with higher scores indicating better function. The Cumberland Ankle Instability Tool evaluates the severity of ankle instability during sport and activities of daily living, as well as pain.

  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

  The Foot and Ankle Ability Measure: Activities of Daily Living subscale is a 21-item questionnaire with 84 points max, with higher scores indicating better function. The Activities of Daily Living Subscale is used to assess activity limitations and restrictions for individuals with foot and ankle disorders, including ankle sprains, during activities of daily living.

  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

  The Foot and Ankle Ability Measure: Sports subscale is a 8-item questionnaire with 32 points max, with higher scores indicating better function. The Sports Subscale is used to assess activity limitations and restrictions for individuals with foot and ankle disorders, including ankle sprains, during recreational/sport activities.

  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.

Secondary Outcomes (11)

• Change in the Lower Extremity Functional Scale

  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 Tampa Scale of Kinesiophobia

  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 Numeric Pain Rating Scale

  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 Godin Leisure-Time Physical Activity Questionnaire

  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 Y Balance Test

  Baseline assessment (0 weeks) and discharge assessment (6 weeks).

Study Arms (2)

Uneven Treadmill Arm

EXPERIMENTAL

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

Other: Uneven Treadmill Intervention

Control Arm

ACTIVE COMPARATOR

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

Other: Standard of Care Physical Therapy

Interventions

Uneven Treadmill Intervention OTHER

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.

Uneven Treadmill Arm

Standard of Care Physical Therapy OTHER

Standard of Care Physical Therapy

Control Arm

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify 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 limitation.
• Able to attend treatment sessions for approximately a 6-week period.
• Passed most recent physical fitness test (Active duty only).
• 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.
• 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.

You may not qualify 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 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).
• 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.

Sponsors & Collaborators

• Henry M. Jackson Foundation for the Advancement of Military Medicine: lead
• United States Naval Medical Center, San Diego: collaborator
• Fort Sam Houston: collaborator
• Naval Hospital Camp Pendleton: collaborator
• Naval Health Research Center: collaborator
• VA Puget Sound Health Care System: collaborator

Study Sites (2)

Naval Hospital Camp Pendelton

Oceanside, California, 92055, United States

RECRUITING

Naval Medical Center San Diego

San Diego, California, 92134, United States

RECRUITING

Related Publications (1)

• Russell Esposito E, Farrokhi S, Shuman BR, Sessoms PH, Szymanek E, Hoppes CW, Bechard L, King D, Fraser JJ. Uneven Treadmill Training for Rehabilitation of Lateral Ankle Sprains and Chronic Ankle Instability: Protocol for a Pragmatic Randomized Controlled Trial. JMIR Res Protoc. 2022 Jun 22;11(6):e38442. doi: 10.2196/38442.

  PMID: 35731551 DERIVED

MeSH Terms

Conditions

Ankle Injuries; Reinjuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Officials

• Pinata Sessoms, PhD

  Naval Health Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pinata Sessoms, PhD

CONTACT

619-553-7760; Pinata.h.sessoms.civ@health.mil

Sara Gorczynski, PT DPT

CONTACT

619-532-9704; sara.r.gorczynski.ctr@health.mil

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors will be blinded to group assignment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will be implemented using multi-site, parallel randomized clinical trial. Individuals will be randomly allocated between a control and experimental arm, stratified between lateral ankle sprains and chronic ankle instability.

Study Record Dates

• First Submitted: July 20, 2021
• First Posted: August 11, 2021
• Study Start: November 23, 2021
• Primary Completion: September 30, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Roughly 12 months after data collection completion as part of study publications.

Locations

US (2)