跳至主要内容
临床试验/NCT04503421
NCT04503421已完成不适用

Use of Blood Flow Restriction (BFR) Therapy in Post-operative Rehabilitation Following Distal: A Prospective Randomized Control Trial

Henry Ford Health System2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2020年8月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
64
试验地点
2
主要终点
Strength

研究概览

简要总结

The goal of this investigation is to determine if using BFR during postoperative therapy would lead to increased and expedited strength gains. Additionally, the investigators would like to determine if BFR is beneficial in preventing muscle atrophy and fatty infiltration in the setting of bicep tendon tears, due to the altered tension-length relationship following surgery. The study will also look at patient reported outcomes metrics and pain scores to determine if BFR has a significant impact on the patient experience surrounding distal biceps tear and surgical repair

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-80
  • Undergoing distal biceps tendon repair

排除标准

  • Revision Biceps tendon repair,
  • Irrepairable tendon injury,
  • Biceps repairs with biologic augmentation,
  • Patients with concomitant neurovascular injury,
  • Inability to tolerate BFR treatment,
  • Unable to complete full course of physical therapy,
  • Peripheral vascular disease,
  • History of Venous thromboembolism (VTE)

结局指标

主要结局

Strength

时间窗: 6 months post-operatively

measured via dynamometer (pounds)

次要结局

  • Range of Motion(6 months post-operatively)
  • Perceived Pain(6 months post-operatively)
  • Patient reported outcome scores(6 months post-operatively)

研究者

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

Charles S Day

Orthopedic Surgeon

Henry Ford Health System

研究点 (2)

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