REPAIR: Rehabilitation Enhanced by Partial Arterial Inflow Restrictions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 219
- 试验地点
- 16
- 主要终点
- Knee Strength measured using a stabilized hand held dynamometer
研究概览
简要总结
The Rehabilitation Enhanced by Partial Arterial Inflow Restriction (REPAIR) Study will be conducted in a patient population of individuals recovering from a traumatic diaphyseal fracture of the femur. Although the intervention can be used for any patient with muscle weakness following trauma, the persistent thigh weakness that follows a femur fracture provides a perfect model for evaluating the effectiveness of the REPAIR protocol.
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
- •Adults ages 18-55 inclusive
- •Admitted to one of the participating clinical centers for operative treatment of a closed diaphyseal femur fracture with one of the following OTA codes: 32A, 32B or 32C (treated with an IM Nail).
排除标准
- •Open diaphyseal femur fracture (except low velocity gunshot wounds) or severe crushing injuries to study limb.
- •Additional fracture, dislocations or soft tissue injuries to the study limb that would compromise the ability to weight bear as tolerated and initiate PT within 28 days of definitive fixation.
- •Any fractures, dislocations or soft tissue injuries to the contralateral limb or pelvis that would compromise the ability to weight bear as tolerated and initiate PT within 28 days of definitive fixation.
- •Any treatment of the study injury in either group that would preclude application of the tourniquet cuff (e.g. vascular reconstruction, wound, flap, or skin graft).
- •Injuries to other body systems (or other medical conditions) that would preclude the ability to weight bear as tolerated and initiate PT within 28 days of definitive fixation (e.g. spinal cord deficit; severe traumatic brain injury).
- •Use of blood flow restriction (BFR) at any time between treatment and the start of physical therapy for the study.
- •Non-ambulatory pre-injury.
- •Morbidly obese (BMI > 40).
- •History of Peripheral Artery Disease and/or Peripheral Vascular Disease (PAD/PVD).
- •Current or history of venous thromboembolism.
- •Impaired circulation or peripheral vascular compromise.
- •Previous revascularization at the study injury site.
- •Extremities with dialysis access.
- •Current diagnosis of acidosis.
- •Diagnosis of sickle cell anemia.
- •Current infection of the study injury.
- •Current tumor (malignant or benign) distal to study injury and future tourniquet placement.
- •Current use of medications or supplements that are known to increase clotting risk.
- •Diagnosis of severe hypertension (blood pressure of 180/110).
- •Skin grafts in which all bleeding points must be readily distinguished.
- •Secondary or delayed surgical procedures to study injury after immobilization.
- •Vascular grafting to the study injury.
- •History of lymphotomies.
- •Current diagnosis of cancer.
- •Unable to speak either English or Spanish.
- •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 document psychiatric disorders).
- •Unable to provide informed consent.
- •Patient has not been cleared to start physical therapy at the time of consent.
- •Patient is pregnant.
- •Patient received BFR between date of injury and start of Physical Therapy.
研究组 & 干预措施
Standard of Care Physical Therapy
This group will receive the standard of care physical therapy program for 6 weeks.
Blood Flow Restriction Plus Standard of Care Physical Therapy
This group will receive the same standard of care physical therapy program for 6 weeks plus blood flow restriction.
干预措施: Blood Flow Restriction (Other)
Blood Flow Restriction Plus Standard of Care Physical Therapy
This group will receive the same standard of care physical therapy program for 6 weeks plus blood flow restriction.
干预措施: Delfi PTSII Tourniquet System (Device)
结局指标
主要结局
Knee Strength measured using a stabilized hand held dynamometer
时间窗: up to 6 months
Knee strength will be measured using a stabilized hand held dynamometer in both the injured and uninjured legs.
Muscle Volume assessed using mid-thigh girth circumference measurement
时间窗: up to 6 months
Two measures of thigh circumference were taken using a flexible measuring tape to estimate muscle volume; one measure was taken at 6 centimeters and one measure taken at 16 centimeters from the superior pole of the patella.
次要结局
- Speed(up to 6 months)
- Return to Work and Work Productivity measured using the Work Productivity and Activity Impairment (WPAI) questionnaire(up to 1 year)
- Agility(up to 6 months)
- Strength(up to 6 months)
- Physical Function(up to 1 year)
- Complications(up to 1 year)
- Posture Stability(Change in Functional Performance Measures at 3 months and 6 months)
- Depression evaluated with a depression questionnaire(up to 1 year)
- Sleep Disturbance evaluated with a sleep disturbance questionnaire(up to 1 year)
- Pain evaluated with a Pain Inference scale(up to 1 year)
- Anxiety evaluated with an anxiety questionnaire(up to 1 year)
- Satisfaction with Care and Recovery assessed using the MedRisk Instrument for Measuring Patient Satisfaction with Physical Therapy Care (MRPS)(3 months)
- Psychological outcome-Post Traumatic Stress (PTSD) measured using the standard PTSD Checklist (PCL)(up to 1 year)
- Fracture Healing(up to 1 year)