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临床试验/NCT02308618
NCT02308618已完成不适用

Achilles Tendon Rupture: Comparative Study Between Two Rehabilitation Programs.

Federal University of Rio Grande do Sul1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2008年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
48
试验地点
1
主要终点
Heel rise test (HRT)

研究概览

简要总结

The purpose of this study is to evaluate the effects of early mobilization versus traditional immobilization rehabilitation programs after surgical Achilles tendon repair on the mechanical (torque-angle and torque-velocity relationships) and electrical (neuromuscular activation) properties of the plantar- and dorsiflexor muscles, gastrocnemius medialis morphology (muscle architecture), functional performance, and the mechanical and material properties (force-elongation and stress-strain relationships) of the injured and uninjured Achilles tendon.

The hypothesis is that the early mobilization could reduce the deleterious effects of the joint immobilization and improve the tendon healing.

详细描述

Participants were allocated into one of two intervention groups (traditional immobilization or early mobilization).

Traditional immobilization group (45 days of plaster cast immobilization; after the immobilization period, subjects received instructions on how to perform a home-based exercise program)

Early mobilization (six weeks of physical therapy program; three times per week; one to two hours of exercises for regaining range of motion and muscular endurance)

Control group (subjects had no history of lower limb injury, and were matched in age and anthropometric measurements to subjects that performed physical rehabilitation and to subjects that remained immobilized.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Achilles tendon rupture

排除标准

  • arterial insufficiency
  • autoimmune disease
  • patients who used systemic antibiotics or steroids or showed any other clinical contraindication to perform maximum voluntary contractions on a dynamometer.

研究组 & 干预措施

Traditional Immobilization

Experimental

45 days of plaster cast immobilization After the immobilization period, subjects received instructions on how to perform a home-based exercise program

干预措施: Traditional Immobilization (Other)

Early mobilization

Experimental

Six weeks of physical therapy program

干预措施: Early Mobilization (Other)

Control

No Intervention

Subjects had no history of lower limb injury, and were matched in age and anthropometric measurements to subjects that performed physical rehabilitation and to subjects that remained immobilized.

结局指标

主要结局

Heel rise test (HRT)

时间窗: Heel rise height was measured 3 times during the study: three, six and more than 12 months after surgical repair.

Heel rise height is an expression of ankle plantarflexor functional performance and was assessed using the HRT.

次要结局

  • Ankle range of motion change(Ankle range of motion was measured 5 times during the study: 15 days, 45 days, three, six and more than 12 months after surgical repair.)
  • Muscular architecture change(Muscle architecture was measured 4 times during the study: 45 days, three, six and more than 12 months after surgical repair.)
  • Plantarflexor muscle volume change(Plantarflexor muscle volume was assessed 4 times during the study: 45 days, three, six and more than 12 months after surgical repair.)
  • Muscular torque change(Torque was measured 3 times during the study: three, six and more than 12 months after surgical repair.)

研究者

发起方
Federal University of Rio Grande do Sul
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marco Aurélio Vaz, PhD

PhD

Federal University of Rio Grande do Sul

研究点 (1)

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