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临床试验/NCT05844280
NCT05844280撤回不适用

The Role of Blood Flow Restriction Therapy in Postop Rehabilitation of Foot and Ankle Injuries

University of Alabama at Birmingham0 个研究点目标入组 28 人开始时间: 2026年8月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
入组人数
28
主要终点
Assess for calf muscle atrophy as measured by calf circumference

研究概览

简要总结

The purpose of the study is to determine the role of blood flow restriction (BFR) + neuromuscular electrical stimulation (NMES) in improving post-operative physical therapy and recovery after ankle fracture surgery. We expect to see improved muscle strength, less muscle wasting, and improved functional recovery after surgery when making these additions to routine post-operative (postop) physical therapy protocols.

详细描述

Few studies have examined BFR in patients sustaining operative foot and ankle injuries. Due to the weight bearing limitations and prolonged immobilization following these injuries, patients often experience increased time away from work and delays with return to sport. These factors are responsible for the rapid muscle atrophy that occurs in the immediate post injury period because of immobility and disuse. Recently, blood flow restriction (BFR) therapy has been shown to be effective in improving muscle strength and preventing atrophy when combined with low load resistance training physical therapy programs.7,8 Neuromuscular electrical stimulation (NMES) is an adjunctive agent that has been show to augment the effects of BFR alone.4 The null hypothesis is that a 2 week BFR + NMES + low load resistance training program in patients age >= 18 recovering from foot and ankle surgery will have no effect on short term (2 weeks postop) lower extremity muscle hypertrophy or atrophy, patient pain and satisfaction, or functional recovery after foot and ankle surgery.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • isolated, closed low-energy rotational ankle fracture without prior surgery or implants to injured area

排除标准

  • history of Deep Vein Thrombosis in affected extremity
  • history of significant cardiac disease defined as a recent stent placement in past
  • history of peripheral arterial disease
  • history of sickle cell disease
  • history of coagulopathy
  • presenting to surgery >14 days after injury

结局指标

主要结局

Assess for calf muscle atrophy as measured by calf circumference

时间窗: 2 weeks postop

Calf circumference will be measured using a measuring tape

Assess for calf muscle atrophy as measured by hand held dynamometry

时间窗: 2 weeks postop

Hand held Dynamometry will be used to measure the length-tension relationship of the muscle in pounds

次要结局

  • Patient tolerance of the BFR treatment using the Visual Analogue Pain Scale.(2 weeks postop)
  • Patient tolerance of the BFR treatment using the the Borg Rating of Perceived Exertion f(2 weeks postop)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Johnson

Principal Investigator

University of Alabama at Birmingham

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