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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.
• Другое Standard of Care Physical Therapy
  Standard of Care Physical Therapy

Первичные конечные точки

• Change in the Cumberland Ankle Instability Tool [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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.]

Вторичные конечные точки (11)

• Change in the Lower Extremity Functional Scale [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline assessment (0 weeks) and discharge assessment (6 weeks).]
• Change in the Side Hop Test [Срок оценки: Baseline assessment (0 weeks) and discharge assessment (6 weeks).]
• Change in the Edgren Side Step Test [Срок оценки: Baseline assessment (0 weeks) and discharge assessment (6 weeks).]
• Change in the T-Test [Срок оценки: Baseline assessment (0 weeks) and discharge assessment (6 weeks).]
• Change in Electromyography (EMG) [Срок оценки: Baseline assessment (0 weeks) and discharge assessment (6 weeks).]
• Change in the Plantar Pressures [Срок оценки: Baseline assessment (0 weeks) and discharge assessment (6 weeks).]
• Ankle Reinjury Status [Срок оценки: Over an 18 month follow-up period.]

Критерии участия

Критерии включения

• 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:

• 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.
• Chronic ankle instability specific inclusion criteria:

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Naval Hospital Camp Pendelton — Oceanside
• Naval Medical Center San Diego — San Diego

Публикации

• 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

Идентификаторы

NCT: NCT04999904 · 937017 · W81XWH-20-2-0056

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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