A Proprioceptive Training Program Using an Uneven Terrain Treadmill for Patients With Ankle Instability
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 312
- 试验地点
- 2
- 主要终点
- Change in the Cumberland Ankle Instability Tool
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Assessors will be blinded to group assignment
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •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.
研究组 & 干预措施
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
干预措施: Uneven Treadmill Intervention (Other)
Control Arm
Standard of Care Physical Therapy over approximately six weeks with an 18 month follow-up period
干预措施: Standard of Care Physical Therapy (Other)
结局指标
主要结局
Change in the Cumberland Ankle Instability Tool
时间窗: 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.
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
时间窗: 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.
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
时间窗: 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.
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.
次要结局
- 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 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 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 T-Test(Baseline assessment (0 weeks) and discharge assessment (6 weeks).)
- Change in the Plantar Pressures(Baseline assessment (0 weeks) and discharge assessment (6 weeks).)
- Change in the Y Balance Test(Baseline assessment (0 weeks) and discharge assessment (6 weeks).)
- Change in the Edgren Side Step Test(Baseline assessment (0 weeks) and discharge assessment (6 weeks).)
- Ankle Reinjury Status(Over an 18 month follow-up period.)
- 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 Side Hop Test(Baseline assessment (0 weeks) and discharge assessment (6 weeks).)
- Change in Electromyography (EMG)(Baseline assessment (0 weeks) and discharge assessment (6 weeks).)