Neuromuscular Electrical Stimulation in Foot and Ankle Surgery: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Isometric Strength of Gastrocnemius Muscle
研究概览
简要总结
This is a pilot randomized controlled trial, wherein the intervention group will undergo NMES five days a week beginning three weeks postoperative and lasting for ten weeks. Both the control and intervention groups will start standard physical therapy six weeks postoperative. Primary outcome measure will be the isometric strength of the gastrocnemius muscle. The secondary outcomes will comprise subjective clinical evaluations (using the Lower Extremity Functional Scale [LEFS]), functional assessments such as the sit-to-stand test, 2-minute walk test, stair climb test and objective clinical evaluation using contralateral comparison of calf circumference.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Capable and willing to provide informed consent
- •Undergoing a procedure that involves repairing an ankle fracture.
排除标准
- •Patients with medical histories that include:
- •Rheumatoid arthritis
- •Connective tissue disorders
- •Chronic corticosteroid use
- •Implanted electrical devices
- •Neurological disorders
- •Non-ambulatory status
- •Recent surgery (within the last 3 months) that is not related to the study
- •Scheduled to undergo surgery in the near future
- •Diagnosed with cancer
- •Have suffered acute trauma or recently have had a surgical procedure (not related to the study)
- •Have cardiac problems or cardiac disease
- •Have an abdominal hernia
- •Have venous thrombosis
结局指标
主要结局
Isometric Strength of Gastrocnemius Muscle
时间窗: Week 12
Measured using Biodex dynamometer.
Bilateral Calf Circumference
时间窗: Week 12
次要结局
- Sit-to-Stand Test(Week 12)
- Stair Climb Test(Week 12)
- 2 Minute Walk Test(Week 12)
- Lower Extremity Functional Scale (LEFS) Questionnaire Score(Week 12)