Blood Flow Restriction Training After Patellar INStability (BRAINS Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 78
- 试验地点
- 8
- 主要终点
- MRI T1rho
研究概览
简要总结
This research study is designed to allow health care professionals and researchers to answer many questions about whether a new type of physical therapy called blood flow restriction training (called BFRT) will improve recovery for those with patellar instability.
详细描述
Participants will randomly be assigned to 1 of 2 groups. This means that neither the participant or their doctor will not choose the treatment, but that the treatment will be randomly selected (like a coin toss). The study treatments is blood flow restriction training (BFRT). BFRT uses an air cuff that is inflated around the top of the thigh. This temporarily limits blood flow to the muscles and may allow the participant to recover strength more quickly after injury. As will be described later, the participant will be closely monitored during all study treatments to make sure they are as safe as possible.
The two groups that participants could be assigned to are:
- Standard physical therapy
- Standard physical therapy and BFRT
Physical Therapy Sessions: We are comparing two physical therapy interventions, one is the standard of care and the other is the standard of care plus an additional treatment. Participants have a 50/50 chance of receiving either treatment. If randomized to receive BFRT, the air cuffs will then be placed on the participants' thighs and they will be doing a standardized exercise program that will vary depending on the stage of rehabilitation they are in and as determined by the study personnel. Participants will also complete a standardized course of physical therapy. Activities in physical therapy may include ice over the knee, range of motion exercises to maintain hip strength and gait training exercises as needed.
The following procedures may be performed. Some procedures may not be performed due to time constraints, availability of equipment, and/or by the decision of the investigator. Before initiating physical therapy, participants will be asked some questions including but not limited to the following: age, sex, level of activities, and expectations. Participants will also complete a Sports Activity Scale to determine their physical activity level.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of traumatic patellar instability (either primary or recurrent) determined by an American Board of Family Medicine certified physician with a Certificate of Added Qualifications in Sports Medicine or licensed Physical Therapist utilizing clinical examination, radiographic imaging, and patients' reports of instability
- •Age 14 to 40 years
- •Skeletally mature with closed growth plates visualized by radiograph
- •A score of 80 or more on the Sports Activity Scale, which corresponds to participating in "running, twisting, turning (tennis, racquetball, handball, ice hockey, field hockey, skiing, wrestling)" at least 1-3 times per week
- •Desire to resume pre-injury activity level
排除标准
- •Concomitant osteochondral lesion requiring surgical fixation
- •Radiographic evidence of osteoarthritis (< Kellgren-Lawrence Grade 2)
- •Previous ipsilateral or contralateral knee surgery
- •Most recent instability event more than 3 months before enrollment
- •History of any inflammatory disorder
- •BMI > 35 kg/m2
- •Diabetes or uncontrolled hypertension
- •Varicose veins or a history of personal or immediate family history (parental or sibling) of deep vein thrombosis
- •Pre-existing conditions or previous surgeries that effect the ability to walk
- •Planned trips or vacations that will result in the inability to attend 4 consecutive physical therapy sessions
研究组 & 干预措施
Standard Physical Therapy with BFRT
Participants will undergo 8 weeks of blood flow restriction training with cuff inflated to 60% occlusion.
干预措施: Blood Flow Restriction Training (Device)
Standard Physical Therapy with Sham BFRT
Participants will undergo 8 weeks of sham blood flow restriction training with cuff inflated to less than 10% occlusion.
干预措施: Sham Blood Flow Restriction Training (Device)
结局指标
主要结局
MRI T1rho
时间窗: 12 Months
Increased T1rho relaxation times have been associated with loss of proteoglycan content. This then corresponds with MRI changes associated with the loss of proteoglycan content. Patients with patellofemoral pain and maltracking have been demonstrated to have significantly greater T1rho relaxation times in the lateral facet of the patella when compared to healthy volunteers.
Quadriceps Strength Symmetry
时间窗: 12 Months
Isokinetic Dynamometer will be used. The primary analysis may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences.
The Norwich Patellar Instability Scale
时间窗: 12 Months
The Norwich Patellar Instability (NPI) Scale is a 19-item scale that asks subjects to rate their perceived patellar instability during different tasks, and has been demonstrated to be a valid and responsive tool for assessing patient-reported outcomes for those being treated conservatively or surgically following patellar dislocation. The NPI is scored on a scale of 0 to 100, with lower scores being indicative of less perceived instability
次要结局
- MRI Muscle Volume(24 Months)
- Quadriceps Strength Symmetry(24 Months)
- The Norwich Patellar Instability Scale(24 Months)
- MRI T1rho(24 Months)
研究者
Caitlin Conley
Assistant Professor
University of Kentucky