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

Primary Purpose

Instability; Ankle (Ligaments) (Old Injury), Sprain of Ankle

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Uneven Treadmill Intervention

Standard of Care Physical Therapy

About this trial

This is an interventional treatment trial for Instability; Ankle (Ligaments) (Old Injury) focused on measuring Acute Ankle Sprain, Chronic Ankle Instability, Proprioceptive Training, Uneven Treadmill, Reinjury, Rehabilitation, Service Members

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesDoes not accept healthy volunteers

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:
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.
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.''
Individual is about to start care with physical therapy.

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.
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.

Sites / Locations

Naval Hospital Camp PendeltonRecruiting
Naval Medical Center San DiegoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Uneven Treadmill Arm

Control Arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

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.

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

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.

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.

Change in Electromyography (EMG)

EMG will be collected during walking to examine muscle activation timings and magnitudes.

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.

Ankle Reinjury Status

Timing of any ankle reinjuries during the follow-up period period will be recorded.

Full Information

NCT ID

NCT04999904

First Posted

July 20, 2021

Last Updated

March 30, 2022

Sponsor

Henry M. Jackson Foundation for the Advancement of Military Medicine

Collaborators

Extremity Trauma and Amputation Center of Excellence, United States Naval Medical Center, San Diego, Madigan Army Medical Center, Fort Sam Houston, Naval Hospital Camp Pendleton, Naval Health Research Center, Veterans Affairs Puget Sound Health Care System

1. Study Identification

Unique Protocol Identification Number

NCT04999904

Brief Title

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

Acronym

ROCKY REHAB

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Recruiting

Study Start Date

November 23, 2021 (Actual)

Primary Completion Date

March 2023 (Anticipated)

Study Completion Date

September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Henry M. Jackson Foundation for the Advancement of Military Medicine

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Instability; Ankle (Ligaments) (Old Injury), Sprain of Ankle

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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.

Masking

Outcomes Assessor

Masking Description

Assessors will be blinded to group assignment

Allocation

Randomized

Enrollment

312 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Uneven Treadmill Arm

Arm Type

Experimental

Arm Description

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

Arm Title

Control Arm

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Uneven Treadmill Intervention

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Standard of Care Physical Therapy

Intervention Description

Standard of Care Physical Therapy

Primary Outcome Measure Information:

Title

Change in the Cumberland Ankle Instability Tool

Description

Time Frame