The Effect of Low-Intensity Blood Flow Restriction Therapy on the Management of Acute Ankle Sprains
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Time to Return to Play
研究概览
简要总结
The primary objective of this study is to evaluate the feasibility of implementing BFR in the rehabilitation treatment of isolated ankle sprains as well as to evaluate the clinical benefits of BFR when compared to standard treatment. This study will evaluate the efficacy of using BFR therapy for the treatment of acute grade I and II ankle sprains. The investigators will evaluate clinical outcomes of range of motion (ROM) and strength testing of ankle dorsiflexion, plantarflexion, inversion, and eversion.
This will be a small, randomized control trial study. The investigators will enroll a total of 40 participants, 20 participants will undergo standard physical therapy for isolated lateral ankle sprains and 20 participants will undergo BFR therapy for an isolated lateral ankle sprain. Patients will be randomized into control and experimental group via block randomization.
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
- Single (Outcomes Assessor)
盲法说明
The assessors will not be aware of group allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will include English speaking student athletes aged 18 and older with clinical diagnosis of an isolated grade I or II lateral ankle sprain
排除标准
- •History of DVT/PE, clotting disordered, peripheral arterial disease, hypertension (BP>140/90), coronary artery disease, or pregnancy
结局指标
主要结局
Time to Return to Play
时间窗: From Time of Injury to 8 weeks after Injury
Time from injury to to when injured ankle regains 90% plantarflexion strength compared to uninjured/contralateral side, using a dynamometer.
次要结局
- The Foot and Ankle Ability Measure (FAAM) Patient-Reported Score(Initial visit & 1, 2, 4, and 8 weeks after the initial visit)
- Range of Motion(Initial visit & 1, 2, 4, and 8 weeks after the initial visit)
- Pain Level(Initial visit & 1, 2, 4, and 8 weeks after the initial visit)
- Strength Testing(Initial visit & 1, 2, 4, and 8 weeks after the initial visit)
- Foot and Ankle Outcome Score (FAOS) Patient-Reported Score(Initial visit & 1, 2, 4, and 8 weeks after the initial visit)
研究者
Eric N. Bowman
Assistant Professor of Orthopaedic Surgery, Division of Sports Medicine
Vanderbilt University Medical Center