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临床试验/NCT02674841
NCT02674841已完成不适用

Efficacy of Live Feedback to Increase Objectively Monitored Adherence to Prescribed, Home-based, Exercise Therapy-dosage in 15 to 19 Year Old Adolescents With Patellofemoral Pain. A Randomized Controlled Superiority Trial

Aalborg University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年2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
40
试验地点
1
主要终点
Mean deviation from the prescribed TUT per repetition in seconds during the course of the intervention

研究概览

简要总结

This study investigates if live feedback during home-based exercises will improve the ability to perform the exercises with the prescribed time under tension (TUT) per repetition compared with no feedback among adolescents with patellofemoral pain. The hypothesis is that adolescents who receive live feedback from BandCizer™ will have a mean TUT that is significantly closer to the prescribed TUT compared to the group not receiving feedback during the course of the intervention.

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
15 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •15 to 19 years of age
  • •Anterior knee pain of non-traumatic origin which is provoked by at least two of the following activities: prolonged sitting with bended knees or kneeling, squatting, running, jumping or ascending or descending stairs
  • •Tenderness on palpation of the peripatellar borders
  • •Pain of more than 6 weeks duration
  • •Worst pain during the previous week ≥ 30 mm on a 100 mm VAS

排除标准

  • •Concomitant pain from other structures in the knee (e.g. ligament, tendon or cartilage), the hip or the lumbar spine
  • •Previous knee surgery
  • •Patellofemoral instability

研究组 & 干预措施

Control group

Active Comparator

Receives no feedback on TUT but on pulling force during exercises.

干预措施: Exercise (Other)

Feedback group

Experimental

Receives live feedback on TUT and pulling force during exercises.

干预措施: Feedback on TUT (Other)

Feedback group

Experimental

Receives live feedback on TUT and pulling force during exercises.

干预措施: Exercise (Other)

Control group

Active Comparator

Receives no feedback on TUT but on pulling force during exercises.

干预措施: No feedback on TUT (Other)

结局指标

主要结局

Mean deviation from the prescribed TUT per repetition in seconds during the course of the intervention

时间窗: From 0-6 weeks

The mean deviation is calculated as the difference between actual TUT and prescribed TUT (8 seconds). E.g. if the actual TUT is 6.5 seconds, the deviation is 1.5 seconds

次要结局

  • Pain measured on a 100 mm VAS(From 0-6 weeks)
  • Global rating of change(At the 6 week follow up)
  • Pulling force exerted per repetition measured in kilos(From 0-6 weeks)
  • Isometric strength(At baseline and at the 6 week follow up)
  • Kujala Patellofemoral Scale-score(At baseline and at the 6 week follow up)
  • Summary of resistance(From 0-6 weeks)
  • The total number of repetitions performed(From 0-6 weeks)

研究者

发起方
Aalborg University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Skovdal Rathleff

Post.doc.

Aalborg University

研究点 (1)

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