Early Advanced Weight Bearing for Peri-articular Knee and Pilon Injuries: An RCT Using the Anti-Gravity Treadmill (AlterG)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 20
- 主要终点
- Ankle Osteoarthritis Score (AOS)
研究概览
简要总结
The overall objective of this study is to compare outcomes following early advanced weight bearing (EAWB) using the AlterG antigravity treadmill versus standard of care physical therapy for adult patients with lower extremity periarticular injuries.
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
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18-55
- •Closed or Open (Gustilo Type I, II or IIIA) fractures: Distal femur (AO/OTA 33B, 33C), tibial plateau (AO/OTA 41B, 41C), or Distal tibia/pilon (AO/OTA 43B, 43C)
- •Definitively treated with a plate
- •Ambulatory prior to injury
- •Able to participate in rehab starting 28 days after definitive fixation
- •Meets AlterG requirements (4'8- 6'4; 85-400lbs)
排除标准
- •Medical or psychological disease that would preclude safe functional testing (e.g., severe traumatic brain injury, stroke, heart disease, etc.)
- •Prior joint trauma or disease of the operative extremity that resulted in pain, stiffness, or other limitation to mobility
- •Injury to the contra-lateral limb, upper extremities or axial skeleton that would influence single limb weight-bearing or use of an assistive device
- •Pregnancy
- •Unable to speak English
- •Severe problems with maintaining follow-up (e.g. patients who are prisoners, homeless at the time of injury, who are intellectually challenged without adequate family support, or have documented psychiatric disorders).
- •Unable to provide informed consent.
结局指标
主要结局
Ankle Osteoarthritis Score (AOS)
时间窗: 6 month following study injury
The AOS is an assessment that evaluates joint function by asking patients to rate their pain and disability while performing 18 different activities of daily living using a visual analogue scale
The Knee Injury and Osteoarthritis Outcome Score (KOOS)
时间窗: 6 month following study injury
The KOOS is a 42 item assessment that evaluates joint function by asking patients to rate their symptoms and concerns in 5 domains: pain, other symptoms, function in daily living (ADL), function in sport and recreation, and foot and ankle quality of life on a scale of 0-4.
次要结局
未报告次要终点