Clinical trial NCT04999904: A Proprioceptive Training Program Using an Uneven Terrain Treadmill for Patients With Ankle Instability
Official title: A Proprioceptive Training Program Using an Uneven Terrain Treadmill for Patients With Ankle Instability
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Instability; Ankle (Ligaments) (Old Injury)
Sprain of Ankle
Keywords: Acute Ankle Sprain
Chronic Ankle Instability
Proprioceptive Training
Uneven Treadmill
Reinjury
Rehabilitation
Service Members
Lead sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
Sponsor class: OTHER
Collaborators: name: Extremity Trauma and Amputation Center of Excellence
name: United States Naval Medical Center, San Diego
name: Madigan Army Medical Center
name: Fort Sam Houston
name: Naval Hospital Camp Pendleton
name: Naval Health Research Center
name: Veterans Affairs Puget Sound Health Care System
First posted: 2021-08-11
Enrollment: 312
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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 2-8 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.

Primary outcomes:
measure: Change in the Cumberland Ankle Instability Tool
timeFrame: 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.
measure: Change in the Foot and Ankle Ability Measure, Activities of Daily Living Subscale
timeFrame: 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.
measure: Change in the Foot and Ankle Ability Measure, Sports Subscale
timeFrame: 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:
measure: Change in the Lower Extremity Functional Scale
timeFrame: 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.
measure: Change in the Tampa Scale of Kinesiophobia
timeFrame: 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.
measure: Change in the Numeric Pain Rating Scale
timeFrame: 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.
measure: Change in the Godin Leisure-Time Physical Activity Questionnaire
timeFrame: 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.
measure: Change in the Y Balance Test
timeFrame: Baseline assessment (0 weeks) and discharge assessment (6 weeks).
measure: Change in the Side Hop Test
timeFrame: Baseline assessment (0 weeks) and discharge assessment (6 weeks).
measure: Change in the Edgren Side Step Test
timeFrame: Baseline assessment (0 weeks) and discharge assessment (6 weeks).
measure: Change in the T-Test
timeFrame: Baseline assessment (0 weeks) and discharge assessment (6 weeks).
measure: Change in Electromyography (EMG)
timeFrame: Baseline assessment (0 weeks) and discharge assessment (6 weeks).
measure: Change in the Plantar Pressures
timeFrame: Baseline assessment (0 weeks) and discharge assessment (6 weeks).
measure: Ankle Reinjury Status
timeFrame: Over an 18 month follow-up period.
Other outcomes:
Locations:
city: Oceanside
country: United States
facility: Naval Hospital Camp Pendelton
state: California
city: San Diego
country: United States
facility: Naval Medical Center San Diego
state: California
Study officials:
affiliation: Naval Health Research Center
name: John Fraser, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.