A Randomized, Sham-Controlled Pilot Study of Pulsed Electromagnetic Field Therapy in Promoting the Maintenance of Muscle Following Anterior Cruciate Ligament (ACL) Reconstruction
试验速览
- 阶段
- 不适用
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Muscle Volume
研究概览
简要总结
This is a pilot study that evaluates the effect of PEMF in maintaining muscle mass postoperatively in individuals experiencing clinical immobilisation due ACL reconstruction surgery. Half of the participants will receive the PEMF therapy in combination with standard rehabilitation programme, while the other half will receive sham therapy in combination with standard rehabilitation programme.
详细描述
This is a single-site, randomized, double-blinded, prospective pilot study of the effectiveness of once-weekly PEMF therapy in the promotion of muscle maintenance following ACL reconstruction surgery. Eligible subjects will be randomized in a 1:1 ratio to receive therapy with an active PEMF device or an identical inactive Sham device, in addition to the standard rehabilitation regimen.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who have undergone unilateral first-time athroscopic reconstruction with single bundle hamstring graft using both transtibial and transportal techniques for rupture anterior cruciate ligament
- •Informed consent signed
排除标准
- •Subjects requiring concomitant knee ligament reconstruction
- •Subjects having other than hamstring graft for the ACL reconstruction
- •Subjects with history of cardiac, neurological, and rheumatological diseases, and previous lower limb surgery/ fracture
- •Subjects with Leg circumference > 63 cm
- •Pregnant women
结局指标
主要结局
Muscle Volume
时间窗: Week 1 and Week 16 post-ACL reconstruction
% change in muscle volume at the end of 16 weeks compared to baseline
次要结局
- Knee Injury and Osteoarthritis Outcome Score (KOOS)(Week 16 post-ACL reconstruction)
- Knee and thigh circumference(Baseline and Week 1, 4, 8, 12, 16 post-ACL reconstruction)
- Quadriceps strength(Baseline and Week 8, 12, 16 post-ACL reconstruction)