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临床试验/NCT06413719
NCT06413719撤回不适用

The Effects of Chiropractic Care in Children With Parent-reported Sensory Processing Disorder: a Pilot Observational Study

Life University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
入组人数
20
试验地点
1
主要终点
Adherence

研究概览

简要总结

This trial's main aims are to investigate the feasibility of implementing our novel assessment battery in tandem with normal and customary chiropractic care in a practice-based setting using a pediatric population with parent-reported SPD. More specifically, our primary endpoints are 1) recruitment rate, 2) tolerability, 3) adherence, 4) retention, 5) efficiency, and 6) data quality.

详细描述

The total estimated time requirement for this study is ~60 minutes.

Up to 20 children (ages 5-12) will be recruited in a maximum 3-month enrollment period. The total estimated time requirement for the parent and child is ~1 hour excluding the normal and customary chiropractic care. Per the clinic's normal and customary procedures, a welcome email is sent to each parent who schedules their child for a chiropractic exam at Premier Wellness Care (PWC) chiropractic (Crystal Lake, IL). An addendum will be added to this email briefly introducing the study along with a HIPAA compliant Jotform link to an online screening survey which incorporates the 38-item short sensory profile v1 (SSP-1). Those who complete the online screen and meet the eligibility criteria described below will be notified when they arrive at PWC for their initial exam & offered the opportunity to participate in the study.

Informed consent (IC) and assent (IA) will be collected in a private room within PWC. A PWC staff member (TM) will sit down with each parent & child to review the IC & IA forms and answer any queries. To be enrolled, the parent must sign the IC and the child must acknowledge their willingness to participate verbally (e.g., "yes I would like to do the study") and/or physically (e.g., nod their head & give a 'thumbs up'). It will be made clear to all parents & children that they may decline participation without penalty and declining participation will in no way impact the child's access to normal and customary chiropractic care.

Children will be asked to stand up straight on a scale so the investigators can measure their heights and weights. They will then be asked to sit in a comfortable chair, shown a visual analog scale (VAS), and asked to rate their pain level on a scale from 0 ("no pain") to 10 ("worst pain possible").

To track autonomic nervous system (ANS) activity, children will be asked to place their hand on the class II FDA registered neuroPULSE scanner (CLA Inc., Toronto, ON, Canada) and put their index, middle, & ring fingers onto the sensors. To track sweat gland (i.e., electrodermal, EDA) activity, a safe and unrecognizable low-voltage, high-amplitude current is passed between sensors located at the palmar-surfaces of the index and ring fingers. The pulse rate is measured via photoplethysmography (PPG) whereby blood flow-dependent changes in the quantity of emitted light passing though the fingertip are tracked via a sensor located on the palmar-surface of the middle finger. All signals will be transmitted to an iPad for viewing by the assessor via a secure Wi-Fi connection.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
5 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 5-12 years of age
  • SSP-1 total score no greater than 154

排除标准

  • Unable to perform assessments due to vision, hearing, or movement impairment (e.g., blind, deaf, confined to wheelchair)
  • Unable to perform the assessments due to a preexisting condition whereby quick postural changes are contraindicated (e.g., postural orthostatic tachycardia syndrome (POTS), postural hypotension)
  • Pacemaker or known heart condition that influences the electrical or mechanical function of the heart

研究组 & 干预措施

No Intervention

Children with probable or definite sensory processing challenges per the SSP-1

结局指标

主要结局

Adherence

时间窗: 4 months (data collection period)

% of participants attending \<80% of their chiropractic sessions within the recommended time frame

Efficiency

时间窗: 4 months (data collection period)

Average time to completion of each assessment section

Retention

时间窗: 4 months (data collection period)

% of participants completing the trial

Data quality

时间窗: 6 months (study period)

% of acquisitions unsuitable for analysis for a given assessment

Recruitment rate

时间窗: 3 months (recruitment period)

Average number of subjects enrolled per month

Proportion of participants able to complete assessments

时间窗: 4 months (data collection period)

Proportion of participants unable/unwilling to complete a given assessment as directed. This assesses 'Tolerability'.

次要结局

未报告次要终点

研究者

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

Tyson Perez, DC, PhD

PI

Life University

研究点 (1)

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