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临床试验/NCT04224376
NCT04224376已完成不适用

Improving Maximal Strength in the Initial Postoperative Phase After Anterior Cruciate Ligament Reconstruction Surgery: Randomized Controlled Trial of an App-Based Serious Gaming Approac

Hannover Medical School0 个研究点目标入组 26 人开始时间: 2016年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
26
主要终点
Absolute and relative change in maximum strength

研究概览

简要总结

The investigators designed a prospective randomized trial to evaluate whether an app based active muscle training program (GenuSport) can improve the postoperative strength by starting rehabilitation immediately after primary anterior cruciate ligament (ACL) reconstruction surgery as already shown for patients who underwent total knee arthroplasty. To the investigators knowledge this is the first study analyzing immediate postoperative serious gaming based training with the GenuSport device based on strength improvement.

详细描述

The study is designed as a prospective randomized control trial. Participants awaiting primary ACL reconstruction surgery were recruited at a single tertiary healthcare center between April 2016 and February 2018. An ethical approval has been given by MHH ethic committee and an IRB was involved. Due to different postoperative treatment protocols and different surgical approaches we could include participants between 13 and 46 years. A computer based randomization was performed by generating a list of randomized numbers which have been provided in sealed envelopes by an independent examiner. The postoperative treatment protocol was apart from the use of the GenuSport knee trainer identically standardized. The pain management was the same for all patients, none of the participants received a continuous peripheral nerve block. The postoperative physiotherapy protocol included gait training, assisted walking with crutches, active and passive knee mobilization, strength exercises and stair climbing. In the training group each participant was additionally provided with a GenuSport knee trainer device (prototype plus tablet with software application) with the active knee extension training program for 6 weeks. Except of that fact the postoperative protocol was identical in both groups. Participant had to train five times daily with the knee trainer starting at the day of surgery.

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 (Participant)

入排标准

年龄范围
10 Years 至 50 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients awaiting primary ACL reconstruction surgery
  • Willingness to participate
  • Ability to work with an app based training device

排除标准

  • Additional meniscal suturing
  • Additional collateral ligament repair
  • Additional regenerative cartilage treatment
  • Unwillingness to participate in the study

结局指标

主要结局

Absolute and relative change in maximum strength

时间窗: 6 weeks

Primarily, change in maximum strength was analyzed both, as an absolute difference between week 6 and pre-surgery value (6 weeks - pre-surgery) and as a relative change (6 weeks / pre-surgery).

次要结局

  • Change in clinical outcome(6 weeks)

研究者

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

Clausen, Jan-Dierk Dr.

Principal Investigator

Hannover Medical School

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