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临床试验/NCT04727047
NCT04727047终止不适用

Neuromuscular Electrical Stimulation for Achilles Tendon Rupture Rehabilitation

Penn State University2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2023年2月15日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
8
试验地点
2
主要终点
Ability to perform a single heel rise

研究概览

简要总结

The majority of patients suffering an Achilles tendon rupture develop long term functional deficits in the affected leg. The goal of the proposed study is to evaluate a new rehabilitation protocol using Neuromuscular Electrical Stimulation (NMES) for reducing muscle atrophy and improving tendon properties. If proven beneficial, the proposed protocol can be easily adopted and incorporated as part of routine care for Achilles tendon rupture.

详细描述

Achilles Tendon Ruptures (ATR) are common and permanently affect the function of the lower leg. Regardless of treatment approach the majority of patients develop long term functional deficits, which include decreased plantar flexion strength, lower heel-rise height, and altered gait patterns. It is believed that tendon lengthening and calf muscle atrophy, which develop during the first few weeks of recovery, are major factors contributing to these functional deficits. The initial development of atrophy is likely caused by reduced loading and muscle activity of the affected leg. However, long-term atrophy may be related to tendon elongation. On the other hand, tendon elongation initially rises during the first few weeks of unloading and slowly reduces, but not completely, when loading is resumed. However, atrophied calf muscles may not provide sufficient loading for optimal tendon recovery. Therefore, there seems to be vicious spiral between tendon elongation and muscle atrophy.

The objective of this study is to develop a neuromuscular electrical stimulation (NMES) rehabilitation protocol for Achilles tendon ruptures. Our preliminary data has shown that force applied to the tendon can be modulated using electrical intensity and pad placement. Therefore, NMES can produce significant contraction in the calf muscles and induce controllable, low-magnitude, cyclic loading to the tendon; which cannot be achieved with voluntary muscle contractions. This approach can potentially overcome limitations of the current rehabilitation protocols.

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

入选标准

  • Achilles tendon rupture

排除标准

  • Those unable to understand spoken English.
  • Participants treated non-operatively
  • Augmented surgical repair (i.e., use of additional tissue at the repair site)
  • Tendon ruptures associated with the use of fluoroquinolones (Examples include ciprofloxacin (Cipro), gemifloxacin (Factive), levofloxacin (Levaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), and ofloxacin (Floxin))
  • Allergy to ultrasound gel
  • Any other condition affecting the ability of the participant to walk or jump
  • Any other health conditions known to impair normal healing: Diabetes, Cardiovascular conditions decreasing blood supply to the leg
  • Those unable to consent

结局指标

主要结局

Ability to perform a single heel rise

时间窗: Week 12

The ability of patients to perform a single heel rise using the injured will be tested.

次要结局

  • Tendon length(Week 6 and12)
  • Foot and Ankle Outcome Score (FAOS)(Week 6, 12)
  • Achilles Total Rupture Score(Week 6, 12)
  • Tampa Scale for Kinesiophobia (TSK)(Week 6, 12)
  • Tendon cross-sectional area(Week 6, 12)
  • Gastrocnemius muscle cross-sectional area(Week 1, 6, 12)
  • Soleus muscle cross-sectional area(Week 1, 6, 12)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniel Cortes

Associate Professor

Penn State University

研究点 (2)

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