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临床试验/NCT03042559
NCT03042559已完成不适用

The Effects of Protonics Knee Brace Versus Hamstring Resisted Exercise on Individuals With Patellofemoral Pain Syndrome

Loma Linda University2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2017年2月14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
43
试验地点
2
主要终点
Anterior Pelvic Tilt

研究概览

简要总结

ProtonicsTM Knee brace has been suggested as an intervention for patients with patellofemoral pain syndrome (PFPS). However, the effectiveness of this knee brace compared to traditional conservative methods knee rehabilitation is lacking. The objective of this randomized controlled trial was to compare the effect of ProtonicsTM knee brace vs. sports cord on knee pain and function in patients with PFPS.

详细描述

The purpose of this graduate student research study was to compare the effect of ProtonicsTM knee brace vs. sports cord on knee pain and function in patients with PFPS.

Design: Randomized controlled trial.

Setting: Loma Linda University.

Participants: Subjects with patellofemoral pain will participate in the study.

Intervention: Subjects will be randomized to one of two treatment groups, the ProtonicsTM knee brace or the sport cord to complete a series of resistance exercises over the course of 4 weeks.

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 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects will be males and females who have Patellofemoral pain symptoms for more than 1 month, have pain level ≥ 3 on a Numeric Pain Rating Scale, and pain during at least 2 activities, such as squatting, ascending/descending stairs, and/or running.

排除标准

  • Subjects will be excluded if they have previous traumatic injuries to the knee joint/lower limbs, sign, and symptoms of meniscus tear or ligamentous-related pathology, neurological disorders and being on pain medication."

结局指标

主要结局

Anterior Pelvic Tilt

时间窗: 4 weeks

Anterior Pelvic Tilt: tilting of the pelvic will be measured with CHEK inclinometer. Tilting will be measured while subjects are in a standing position. The examiner will determine the two measure line marks, anterior superior iliac spine (ASIS) and posterior superior iliac spine (PSIS) to find the oblique angle of the pelvic. Approximate normally anterior pelvic tilt for male is 9° and for female is about 12° (Nguyen, 2007). The caliper has two arms; one arm will be placed on ASIP while the other on the PSIS. The angle of the caliper will be determined to record the degree of anterior pelvic tilt.

Numeric Pain Rating Scale (NPRS)

时间窗: 4 weeks

Used to assess pain level throughout the intervention. Scale: 0-10. Scoring: 0 (no pain) to 10 (worst, imaginable pain).

Global Rating of Change (GROC)

时间窗: 4 weeks

GRC scales offer a flexible, quick, and simple method of charting self-assessed clinical progress in research and clinical settings. It ranges from -7 to 7, in which item -7 represent very great deal worse, 0 represent no change in progress, and 7 exemplify a very great better.

Kujala Score

时间窗: 4 weeks

A self-report questionnaire, which is used to evaluate subjective symptoms and functional limitations in subjects with PFPS with a score range between of 0 - 100 based on pain associated with variety of functional activities such as prolonged sitting, squatting, running, and jumping. A score close to 100 indicates a higher functional performance. Kujala scale has shown acceptable test-retest reliability (rho = 0.86) (Paxon et al, 2003). Kujala scale scores will be documented at the beginning and end of the intervention program.

Lateral Step-Down Test

时间窗: 4 weeks

Lateral step test: is a quick and simple practical clinical measure of functional. Subjects with PFPS will be asked to step up and down on a 15-cm step for 15 seconds each with a cadence of 2 steps per second. The total number of step-ups during this time will be recorded. This test will be performed every two weeks to document any improvement in the functional performance. The test has shown to be reliable and valid, with test-retest reliability of (ICC = 0.90) (Ross et al, 1997).

次要结局

  • Hip Internal Rotation ROM(4 weeks)
  • Iliotibial Band Flexibility(4 weeks)
  • Hip External Rotation ROM(4 weeks)

研究者

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

Everett Lohman

Professor

Loma Linda University

研究点 (2)

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