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临床试验/NCT05607355
NCT05607355已完成不适用

Measurement of Spinal Mobilization Biomechanical Parameters in the Preschool Pediatric Population

Université du Québec à Trois-Rivières1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2022年11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
47
试验地点
1
主要终点
Spinal mobilization force

研究概览

简要总结

The goal of this cross-sectional study is to measure the biomechanical parameters during a vertebral mobilization delivered by chiropractors on patients of five years old of age and younger. The main questions it aims to answer are:

  • What is the force and rate of force application of spinal mobilizations in children consulting in chiropractic?
  • What are the adverse events observed by legal tutors immediately following the intervention received by the child?

Participants will receive the clinically indicated spinal mobilization by their treating chiropractor. The chiropractor will have a small sensor on the finger during the delivery of the spinal mobilization. The legal tutor will complete a questionnaire immediately after the intervention to report adverse events.

详细描述

Scope: Number of parents consulting complementary and alternative medicine practitioners for their children's health is increasing. Spinal mobilization is commonly provided by these practitioners, including chiropractors, to address health disorders in children. Spinal mobilization involves the application of a controlled force to a vertebra using a slow speed and is considered an appropriate technique in young children. Despite the popularity of spinal mobilization in the pediatric population, only a paucity of data exists on its biomechanics. One study has evaluated the force used by chiropractors on manikins and one study calculated theoretical values of the maximum force that should be applied in function of the patient age. To date, no studies have characterized spinal mobilization biomechanics using a pragmatic approach: measurement directly at the clinician's hands during spinal mobilization delivered on real pediatric patients.

Purpose: The aims are to (1) measure the biomechanical parameters during spinal mobilization delivered by chiropractors on patients of 5 years of age or younger and (2) to report immediate adverse events.

Methodology:

Design: This research proposal is a pragmatic cross-sectional study. Participants: Patients seeking care at our collaborating chiropractic clinics and aged between 0 (newborn) and 5 years old will be recruited. Spinal mobilization will have to be clinically indicated. A total of 60 participants will be recruited.

Experiment: To measure spinal mobilization parameters, the chiropractor will wear a small sensor on their finger tip used to deliver the spinal mobilization (MedicalSensor 9811E, Tekscan, Boston, US). The sensor record force by time data using a 100 Hz acquisition frequency. Legal guardians will complete a short online questionnaire (pediatric version of the SafetyNet system) immediately following the intervention to report any adverse events. Participant characteristics (age, weight, height, sex, reason to seek care) will also be collected.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
— 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Not requiring a spinal mobilization on the day of data collection.

结局指标

主要结局

Spinal mobilization force

时间窗: During the intervention.

For each spinal mobilization delivered by the chiropractor on the participant, the peak force will be measured.

Spinal mobilization rate of force application

时间窗: During the intervention.

For each spinal mobilization delivered by the chiropractor on the participant, the rate of force will be measured.

次要结局

  • Adverse events(5-min following the intervention)

研究者

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

Isabelle Pagé

Professor

Université du Québec à Trois-Rivières

研究点 (1)

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