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临床试验/NCT04294199
NCT04294199进行中(未招募)不适用

Effect of Early Range of Motion on Recovery in Individuals Following First Time Patellar

Baylor College of Medicine1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年10月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
60
试验地点
1
主要终点
Isokinetic Strength using Biodex

研究概览

简要总结

Do teen-age patients with a dislocated knee cap do better with or without a brace?

详细描述

This study will look at two different ways to treat teen-age patients who have had a dislocation of their knee cap. Both groups will receive the physical therapy treatment for knee cap dislocation but one group will first be in a brace for a week and the other group will start moving in therapy right away.

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
11 Years 至 17 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Male and female adolescents between 11-17 years
  • •Medical diagnosis of 1st time lateral patellar instability episode (dislocation or subluxation)
  • •Subjective history of knee shifting, instability, popping out, knee effusion
  • •Apprehension test is positive and has medial patellar tenderness
  • •Referred to the Texas Children's Hospital (TCH) outpatient sports medicine clinic from an emergency room facility, urgent care or pediatrician within 10 days of the injury.
  • •Free of co-morbidities that would prevent or limit rehabilitation including cardiac, pulmonary, psychiatric (except Attention Deficit Disorder (ADD) or Attention Deficit Hyperactivity Disorder (ADHD), orthopedic, neurological
  • •Must be able to follow directions and participate in rehabilitation protocol for the 3-month study period.

排除标准

  • •Imaging or clinical findings suggest surgical intervention is needed i.e. fracture, osteochondral defect, Lachman or other positive knee ligament special tests.

研究组 & 干预措施

Immobilization

Active Comparator

Patients in this group will be given a knee immobilizer to wear for 2 weeks and then receive outpatient physical therapy evaluation and treatment

干预措施: Early Range of MOtion (Other)

Early range of motion

Experimental

Patients in this group will be allowed to move the knee and start outpatient physical therapy and treatment immediately.

干预措施: Early Range of MOtion (Other)

结局指标

主要结局

Isokinetic Strength using Biodex

时间窗: 30 minutes

Force of movement is measured in newtons and torque and corrected for body weight

Tegner Activity Scale

时间窗: 5 minutes

11 levels of activity from complete inability to function to advanced sports participation

Edema Assessment

时间窗: 2 minutes

Measure of knee circumference

Kujala Knee Score

时间窗: 10 minutes

13 item questionnaire to rate pain, function, ambulation, and instability

Passive Range of Motion

时间窗: 5 minutes

Measured with goniometer to record full range of motion in knee flexion and extension

次要结局

  • Numerical Pain Rating Scale(1 minute)

研究者

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

Scott McKay

Principal Investigator

Baylor College of Medicine

研究点 (1)

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