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临床试验/NCT01821599
NCT01821599已完成不适用

Comparative Study Between Two Physiotherapy Protocols Conventional X Accelerated in Individuals Undergoing Reconstruction of the Anterior Cruciate Ligament.

University of Sao Paulo1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2013年1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
入组人数
29
试验地点
1
主要终点
KT1000 measures

研究概览

简要总结

The accelerated rehabilitation and early return does not seem to be harmful, but still needs further research to define the rehabilitation time is what shows Kruse and collaborators (2012) in their study of systematic review. The surgical treatment of anterior cruciate ligament injury is the gold standard in the treatment of these injuries in young and active, the postoperative rehabilitation is extensive and full return to sport occurs only after 6 months postoperatively. Based on this gap, the investigators seek to draw properly through our study methods and more complex techniques, that comparing two rehabilitation programs can achieve high precision early rehabilitation. This will include 32 athletes who had complete ACL rupture confirmed by MRI and underwent ACL reconstruction using patellar tendon.All subjects will be followed from the pre-surgery, the fourth and sixth month after surgery with: KT1000 measures the ligamentous laxity, knee function by applying the International Knee Documentation Committee (IKDC 2000); Isokinetic Muscle Strength (Cybex). Through a random draw of sealed envelopes, patients will be allocated in their rehabilitation groups: Accelerated (4 months) or Conventional (6 months). Preoperatively, fourth and sixth month after surgery will be an assessment of laxity by (KT1000), Muscular Strength (CYBEX) and knee function affected by IKDC (2000) and Hop Test. The assessor and the patients were blinded to treatment group. This study will have the locus Institute of Orthopaedics and Traumatology, School of Medicine, São Paulo. The comparative results of the two groups are analyzed using specific statistical tests to prove an improved significative without damaging the integrity of the graft.

详细描述

All subjects will be followed for a period of six months. During this period will undergo three stages of evaluation.

  1. º Preoperative up to two years following injury : assessment will consist KT1000 measures the ligamentous laxity, knee function by applying the International Knee Documentation Committee (IKDC 2000); Hop Test (jumps with one leg); Isokinetic Muscle Strength (Cybex).
  2. º 4º months pós-surgery KT1000, International Knee Documentation Committee (IKDC 2000); Hop Test; Isokinetic Muscle Strength (Cybex)
  3. º 6º months postoperatively KT1000, International Knee Documentation Committee (IKDC) + Hop Test; Isokinetic Muscle Strength (Cybex)

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •With diagnosis of injury (primary) anterior cruciate ligament confirmed by magnetic resonance may or may not be associated with a meniscal injury or partial ligament medial collateral ligament (MCL) surgery is not indicated.
  • •Patients undergo surgery for anterior cruciate ligament reconstruction using patellar tendon.

排除标准

  • •Patients who had changes in diagnosis during surgery.
  • •Surgical complications
  • •Patients with More than 30% of lack or abandon physiotherapy.

研究组 & 干预措施

Conventional group

Active Comparator

Nonaccelerated Rehabilitation After Anterior Cruciate Ligament Reconstruction

干预措施: Nonaccelerated Rehabilitation (Other)

Accelerated group

Experimental

Accelerated Rehabilitation After Anterior Cruciate Ligament Reconstruction

干预措施: Accelerated Rehabilitation (Other)

结局指标

主要结局

KT1000 measures

时间窗: Sixth months

Measure of anterior knee stability

次要结局

  • International Knee Documentation Committee (IKDC 2000)(Sixth months)
  • Hop Test measures(sixth months)
  • Isokinetic of the knee measures(sixth months)

研究者

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

José Carlos Alves Fabrício Júnior

Specialist, Master Student

University of Sao Paulo

研究点 (1)

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