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临床试验/NCT04104126
NCT04104126招募中不适用

Blood Flow Restriction Therapy in Achilles Injury

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2021年10月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
57
试验地点
1
主要终点
efficacy of blood flow restriction therapy on patients with Achilles injury by measure pre and post blood flow restriction therapy measured by muscle strength

研究概览

简要总结

Blood flow restriction (BFR) therapy is a brief and partial restriction of venous outflow of an extremity during low load resistance exercises. It is a safe and effective method of improving strength in healthy and active individuals, recovering from orthopedic pathologies and procedures. This prospective, randomized study will look at the implications this form of treatment has on the rehabilitation of Achilles injuries.

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

入选标准

  • Diagnosed with Achilles Injury
  • Must be at least 18 years of age and younger than 65 years of age
  • Intention to receive physical therapy as standard of care

排除标准

  • Patients with intention to receive standard therapy and not the study therapy
  • Patients with impaired circulation, peripheral vascular compromise, previous revascularization of the extremity, or severe hypertension
  • Younger than 18 years of age or older than 65
  • Legally incompetent or mentally impaired (e.g. minors, Alzheimer's subjects, dementia, etc.)
  • Any patient considered a vulnerable subject

研究组 & 干预措施

Standard of Care Physical Therapy

Active Comparator

Patients with Achilles injury are prescribed PT for their treatment, therefore physical therapy is a standard of care treatment for patients with tendon pathology.

干预措施: Standard of Care Physical Therapy (Other)

Blood flow restriction (BFR) therapy

Experimental

Blood flow restriction therapy is a blood pressure cuff placed around the desired limb with a handheld device that controls the pressure exerted by the cuff.

干预措施: Blood flow restriction (Other)

结局指标

主要结局

efficacy of blood flow restriction therapy on patients with Achilles injury by measure pre and post blood flow restriction therapy measured by muscle strength

时间窗: 12 Months

Measure in increase of strength in the affected leg measured by Biodex.

Measure of pain using Visual Analog Scale (VAS)

时间窗: 12 Months

Respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain. For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 \[100-mm scale\])

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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