A Proprioceptive Training Program Using an Uneven Terrain Treadmill for Patients With Ankle Instability (ROCKY REHAB)

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.

Study Overview

• Status: Recruiting
• Conditions: Instability; Ankle (Ligaments) (Old Injury); Sprain of Ankle
• Intervention / Treatment: Other: Uneven Treadmill Intervention; Other: Standard of Care Physical Therapy

Detailed Description

Lower limb sprains and strains are three-times more prevalent than any other acute injury in the Armed Forces, with lateral ankle sprains being the most common injury sustained during active-duty. Many individuals who experience an ankle sprain will go on to develop chronic ankle instability. Training and rehabilitation programs that incorporate proprioceptive training are particularly effective at improving outcomes and reducing re-injury rate. However, current programs do not help individuals "train to the tasks" that will be encountered once those individuals leave physical therapy. The proposed intervention evaluates the use of a rocky, uneven terrain treadmill that specifically targets aspects of the real-world environment for restoring and improving short-term function and performance and reducing the long-term risk of re-injury. This trial will randomly allocate 312 individuals with ankle sprains and chronic ankle instability to standard of care physical therapy or the standard of care supplemented with the uneven treadmill intervention. Patient reported outcome, performance measures, and biomechanical measures of muscle activations and plantar pressures will be evaluated. Patient reported outcomes and reinjury rates will be tracked for 18 months.

• Study Type: Interventional
• Enrollment (Anticipated): 312
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elizabeth Russell Esposito, PhD; Phone Number: 206-277-6267; Email: elizabeth.m.russell34.civ@mail.mil
• Study Contact Backup: Name: Elise Campbell, MS; Phone Number: 206-764-2962; Email: Elise.Campbell@va.gov

Study Locations

• United States
  • California
    • Oceanside, California, United States, 92055
      • Recruiting
      • Naval Hospital Camp Pendelton
      • Contact: Brian Green, PhD; Phone Number: 814-574-6049; Email: brian.s.green38.ctr@mail.mil
    • San Diego, California, United States, 92134
      • Recruiting
      • Naval Medical Center San Diego
      • Contact: Shawn Farrokhi, PT, PhD; Phone Number: 619-532-8582; Email: shawn.farrokhi.civ@mail.mil
      • Principal Investigator: Shawn Farrokhi, PT, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 2-8 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Other: 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.
Active Comparator: Control Arm; Standard of Care Physical Therapy over approximately six weeks with an 18 month follow-up period	Other: Standard of Care Physical Therapy; Standard of Care Physical Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Lower Extremity Functional Scale	The Lower Extremity Functional Scale is a 20-item questionnaire with 80 points max, with higher scores indicating better function. The Lower Extremity Functional Scale is used for individuals with lower extremity musculoskeletal disorders and assesses activity limitations and participation restrictions.	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	The Tampa Scale of Kinesiophobia is a 11-item questionnaire with scores between 11 and 44 points, with higher scores indicating greater kinesiophobia. The Tampa Scale of Kinesiophobia is used to assess subjective ratings of fear-related concepts.	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	The Numeric Pain Rating Scale is a 4-item questionnaire with scores between 0 and 40 points, with higher scores indicating greater pain. In the Numeric Pain Rating Scale subjects select a value that is most in line with the intensity of pain they have experienced in the past 24 hours.	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	The Godin Leisure-Time Physical Activity Questionnaire measures the number of instances where subjects engaged in mild, moderate, and strenuous physical activity for greater than 15 minutes. Modified to account over the previous week rather than a typical week. Higher scores indicate more physical activity where 3, 5, and 9 points are given for each time a mild, moderate, or strenuous activity is engaged.	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	The Y Balance Test measures the distance a subject can reach in three directions, anterior, posteromedial and posterolateral without moving a support foot or touching the reach foot to the floor. The Y Balance Test is scored based on the composite reach distance normalized by the subject's leg length.	Baseline assessment (0 weeks) and discharge assessment (6 weeks).
Change in the Side Hop Test	The Side Hop Test measures the how long in seconds it takes for a subject can hop on one foot across two lines spaced 30 cm apart.	Baseline assessment (0 weeks) and discharge assessment (6 weeks).
Change in the Edgren Side Step Test	The Edgren Side Step Test measures the distance in meters a subject sidestep across in 10 seconds traversing 5 lines 1 meter apart before reversing direction.	Baseline assessment (0 weeks) and discharge assessment (6 weeks).
Change in the T-Test	The T-Test measures the time it takes for a subject to traverse a 40m course in the shape of a "T" consisting of 10m each of forward motion, right side shuffle, left side-shuffle, and backwards motion.	Baseline assessment (0 weeks) and discharge assessment (6 weeks).
Change in Electromyography (EMG)	EMG will be collected during walking to examine muscle activation timings and magnitudes.	Baseline assessment (0 weeks) and discharge assessment (6 weeks).
Change in the Plantar Pressures	Plantar Pressures will be collected during walking to examine pressure distribution and progression of the center of pressure during stance phase.	Baseline assessment (0 weeks) and discharge assessment (6 weeks).
Ankle Reinjury Status	Timing of any ankle reinjuries during the follow-up period period will be recorded.	Over an 18 month follow-up period.

Collaborators and Investigators

• Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
• Collaborators: United States Naval Medical Center, San Diego; Madigan Army Medical Center; Fort Sam Houston; Naval Health Research Center; Extremity Trauma and Amputation Center of Excellence; Naval Hospital Camp Pendleton; Veterans Affairs Puget Sound Health Care System
• Investigators: Principal Investigator: John Fraser, PhD, Naval Health Research Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2021
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): September 1, 2024

Study Registration Dates

• First Submitted: July 20, 2021
• First Submitted That Met QC Criteria: August 3, 2021
• First Posted (Actual): August 11, 2021

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 30, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Rehabilitation; Service Members; Proprioceptive Training; Acute Ankle Sprain; Chronic Ankle Instability; Uneven Treadmill; Reinjury
• Additional Relevant MeSH Terms: Wounds and Injuries; Sprains and Strains
• Other Study ID Numbers: 937017; W81XWH-20-2-0056 (Other Grant/Funding Number: Congressionally Directed Medical Research Program (CDMRP): Peer Reviewed Orthopedic Research Program (PRORP))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: De-identified primary outcome data will be published. Additional outcome data may also be included.
• IPD Sharing Time Frame: Roughly 12 months after data collection completion as part of study publications.
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No