Outcomes of Blood Flow Restriction Training in Post-operative Rehabilitation After Meniscus Repair Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Knee Extension Force at Week 1
研究概览
简要总结
The purpose of this study is to evaluate post-operative outcomes after meniscus surgery in participants undergoing blood flow restriction training as a rehabilitative adjunct compared to those with standard rehabilitation.
详细描述
The investigators will conduct a double-blinded, single-institution, randomized controlled trial to compare patients undergoing arthroscopic meniscus repair with post-operative rehabilitation protocol as (1) a standard-of-care rehabilitative protocol with a non-occlusive blood pressure cuff (inflated to 20-30 mm Hg) applied to the operative extremity versus (2) blood flow restriction training with cuff occlusion applied to the operative extremity. Patients will be enrolled prospectively and pre-operatively at their initial clinic visit after meniscus injury.
Rehabilitative exercises would be advanced per the physical therapists' discretion with similar exercises for patients in both groups for direct comparison. These exercises are part of an already-established post-operative protocol that is in place, with the only difference being the addition of the blood flow restriction protocol in the intervention group. All patients would undergo their supervised post-operative rehabilitation at our institution.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who undergo surgery for arthroscopic meniscus repair
排除标准
- •Participants undergoing surgery for concomitant ligamentous surgeries
- •Patients with Diabetes Mellitus, vascular disease, or infections of the involved extremity
研究组 & 干预措施
Blood flow restriction
The blood flow restriction arm will include the use of the pneumatic tourniquet applied to the operative lower extremity throughout post-operative rehabilitation sessions. The tourniquet pressure will be titrated to 80% of the measured extremity arterial limb occlusion pressure with the participant lying supine.
干预措施: Blood flow restriction (Delfi Personalized Tourniquet System) (Device)
Blood flow restriction
The blood flow restriction arm will include the use of the pneumatic tourniquet applied to the operative lower extremity throughout post-operative rehabilitation sessions. The tourniquet pressure will be titrated to 80% of the measured extremity arterial limb occlusion pressure with the participant lying supine.
干预措施: Standard rehabilitation (Other)
Standard rehabilitation
The standard rehabilitation arm will undergo the same rehabilitation protocol as the experimental arm. A tourniquet will still be applied, but will only be inflated to 20 mmHg, a pressure that will not occlude blood flow.
干预措施: Standard rehabilitation (Other)
结局指标
主要结局
Knee Extension Force at Week 1
时间窗: Week 1 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Peak knee extension force (lbs) evaluated with a hand-held dynamometer
Knee Extension Force at Week 2
时间窗: Week 2 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Peak knee extension force (lbs) evaluated with a hand-held dynamometer
Knee Extension Force at Week 3
时间窗: Week 3 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Peak knee extension force (lbs) evaluated with a hand-held dynamometer
Knee Extension Force at Week 4
时间窗: Week 4 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Peak knee extension force (lbs) evaluated with a hand-held dynamometer
Knee Extension Force at Week 5
时间窗: Week 5 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Peak knee extension force (lbs) evaluated with a hand-held dynamometer
Knee Extension Force at Week 6
时间窗: Week 6 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Peak knee extension force (lbs) evaluated with a hand-held dynamometer
Knee Extension Force at Week 7
时间窗: Week 7 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Peak knee extension force (lbs) evaluated with a hand-held dynamometer
Knee Extension Force at Week 8
时间窗: Week 8 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Peak knee extension force (lbs) evaluated with a hand-held dynamometer
Knee Extension Force at Week 9
时间窗: Week 9 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Peak knee extension force (lbs) evaluated with a hand-held dynamometer
Knee Extension Force at Week 10
时间窗: Week 10 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Peak knee extension force (lbs) evaluated with a hand-held dynamometer
Knee Extension Force at Week 11
时间窗: Week 11 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Peak knee extension force (lbs) evaluated with a hand-held dynamometer
Knee Extension Force at Week 12
时间窗: Week 12 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Peak knee extension force (lbs) evaluated with a hand-held dynamometer
Thigh Circumference at Week 1
时间窗: Week 1 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Thigh Circumference at Week 2
时间窗: Week 2 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Thigh Circumference at Week 3
时间窗: Week 3 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Thigh Circumference at Week 4
时间窗: Week 4 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Thigh Circumference at Week 5
时间窗: Week 5 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Thigh Circumference at Week 6
时间窗: Week 6 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Thigh Circumference at Week 7
时间窗: Week 7 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Thigh Circumference at Week 8
时间窗: Week 8 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Thigh Circumference at Week 9
时间窗: Week 9 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Thigh Circumference at Week 10
时间窗: Week 10 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Thigh Circumference at Week 11
时间窗: Week 11 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Thigh Circumference at Week 12
时间窗: Week 12 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
次要结局
- International Knee Documentation Committee (IKDC) Score at Week 24(6 months (measured at 6 weeks, 3 months, and 6 months post-operatively))
- International Knee Documentation Committee (IKDC) Score at Week 6(6 weeks (measured at 6 weeks, 3 months, and 6 months post-operatively))
- International Knee Documentation Committee (IKDC) Score at Week 12(3 months (measured at 6 weeks, 3 months, and 6 months post-operatively))
- Y-balance Testing at Week 12(3 months (performed at 3 months and 6 months post-operatively))
- Y-balance Testing at Week 24(6 months (performed at 3 months and 6 months post-operatively))
- 3-hop Test at Week 12(3 months (performed at 3 months and 6 months post-operatively))
- 3-hop Test at Week 24(6 months (performed at 3 months and 6 months post-operatively))
- Single Leg Squat Testing at Week 12(3 months (performed at 3 months and 6 months post-operatively))
- Single Leg Squat Testing at Week 24(6 months (performed at 3 months and 6 months post-operatively))