The Effect of Early Treatment With Neuromuscular, Electrical Stimulation (NMES) After Achilles Tendon Rupture
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Heel-rise height during heel-rise work test
研究概览
简要总结
Increased knowledge is needed about new methods how to treat patients with Achilles tendon ruptures (ATR). A goal is to be able to individualize as well as improve treatment beyond the question about if surgery should be used or not.
An overall aim of the project is to, in a randomized controlled trial (RCT), explore what impact a new treatment method with Neuromuscular Electrical Stimulation (NMES) - attached on the patients ́ calf muscles on the injured leg - in the early stages after an ATR, may have on tendon length, functional performance, biomechanical variables and patient reported outcome, both in the short and long term after the injury. 70 patients are planned to be included in this RCT and will be evaluated 3,6 and 12 months after their injury. Primary outcome will be heel-rise height. Secondary outcome will be tendon length, jumping ability, patient- reported outcome and biomechanical loading pattern.
There is also a need to explore if the patients ́ loading patterns improve after treatment with NMES. Therefore, biomechanical variables in lower leg during walking and jumping will also be evaluated one year after their injury.
The planned studies include completely new ways of exploring how to optimize the rehabilitation after an ATR.
Since there might be an increased risk for overuse injuries in the healthy limb, there will also be focus on how the non- injured limb may be affected of an ATR.
Taken together, this new knowledge can be helpful in the clinical setting to individualize and optimize patients' treatment and rehabilitation with the goal to guide the patient return to the same, or higher level of, physical activity as before the injury.
详细描述
BACKGROUND:
There is limited knowledge about how calf muscle performance and tendon elongation affect the patient's discomfort or ability to return to previous activity levels after an Achilles Tendon rupture. Tendon elongation can cause a changed recruitment pattern of the different parts of the muscle complex triceps surae. There is some evidence that treatment with Neuromuscular Electrical Stimulation (NMES) can improve postural balance by stimulating the calf muscles in elderly people with impaired balance. A newly published study concluded that NMES treatment the first 12 weeks after an ATR, did not have any impact on calf circumference or patient-reported outcome the first 12 weeks after the injury.
Studies have shown that only 20-40% of patients are able to return to the same level of physical activity as before the injury. Although patients return to full participation in sports, their level of performance is often adversely affected. Obviously, there can be different reasons for this. In a newly published study, it was concluded that joint power distribution during a drop countermovement jump was affected by fear of reinjury as long as 2 years after an ATR. However, there is still a lot to explore about if an improved physical function in the injured calf muscle may decrease the fear of re-injury and therefore positively affect the ability to return to previous physical activity level after an ATR. Therefore, new treatments with the goal to increase the possibility to return to the same physical level as before the injury are very much needed.
An ATR can lead to reduced strength development in the ankle with simultaneous increased load development in the knee joint in the injured leg for as long as 6 years after the injury. Reduction in strength and endurance in the calf muscle has been shown to persist long after the injury. Exhaustion of the lower leg muscles affects the valgus moment in the knee as well as kinematic variables in athletes during vertical jumps, which may affect the risk of knee injury. However, there is a lack of knowledge about how lower leg function, biomechanics and muscle recruitment are affected in patients after an ATR. It is also unknown how this injury affects the healthy limb and perhaps increase the risk of overload injuries in other parts of the body.
HYPOTHESIS:
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Achilles Tendon rupture
- •The injury should have been treated within two days from the trauma
- •The rupture is located in the mid portion of the tendon
排除标准
- •Pregnancy
- •Having a pace maker, intra cardiac defibrillator or other active implant
- •Having had an Achilles Tendon rupture before, regardless of side
- •Having an earlier injury that will have an impact on lower leg function, regardless of side
- •Neuro vascular disease
- •Immunosuppressive treatment
- •Difficulties to understand the language or difficulties in understand instructions.
- •Unable to consent
结局指标
主要结局
Heel-rise height during heel-rise work test
时间窗: 3 months
Evaluation of heel-rise height during heel-rise work test using. Comparison between groups in heel-rise height (LSI)- injured side/healthy side \*100 expressed in percent. The range in LSI is between 0-100% and the higher value, the better outcome
次要结局
- Tendon length(3 months)
- Soleus cross-sectional area(3 months)
- Electro Myography (EMG) will be evaluated during walking, running and jumping.(12 months)
- Achilles tendon Total Rupture Score (ATRS)(12 months)
- Gastrocnemius Cross-sectional area(3 months)
- Biomechanical data; kinematic data will be evaluated during walking, running and jumping.(12 months)
- Biomechanical data; kinetic data will be evaluated during walking, running and jumping.(12 months)
- Physical Activity Scale (PAS)(3 months)
- Drop Countermovement Jump(12 months)
- Hopping(12 months)
- Calf muscle power(12 months)