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Sensory Processing Challenges: a Pilot Observational Study

NCT ID: NCT07256327

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-15

Study Completion Date

2027-01-15

Brief Summary

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The main aims of this pilot observational study 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.

Detailed Description

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Twenty (20) children with probable or definite parent-reported SPD (i.e., Short Sensory Profile (SSP) total scores ≤154) will be enrolled. More specifically, our primary outcomes are 1) enrollment, 2) tolerability, 3) adherence, and 4) retention. Secondary aims involve assessing the potential effects of subluxation-based chiropractic care on electrocardiography (ECG)-derived heart rate variability (HRV), bilateral weight distribution (BWD), and parent-reported outcomes (PROs). Data from this study will inform our lab regarding the feasibility of a larger study powered to assess the effectiveness of pediatric chiropractic care on clinical outcomes in a pediatric population with SPD.

Conditions

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Sensory Processing Disorder

Keywords

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Sensory Processing Disorder Pediatric chiropractic care autonomic nervous system

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention Group

15 sessions of pediatric chiropractic care

Group Type EXPERIMENTAL

Chiropractic Care

Intervention Type OTHER

15 sessions of normal and customary, fee-for-service, pediatric chiropractic care.

Interventions

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Chiropractic Care

15 sessions of normal and customary, fee-for-service, pediatric chiropractic care.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 5-12 years of age.
* SSP total scores ≤154

Exclusion Criteria

* A known heart condition, including pacemakers
* Chiropractic care within the past 30 days
Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Life University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Daekiara Smith-Ireland, MPH, DrPH

Role: CONTACT

Phone: 17704262636

Email: [email protected]

Tyson Principal Investigator, Phd

Role: CONTACT

Email: [email protected]

Other Identifiers

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I-0036

Identifier Type: -

Identifier Source: org_study_id