NCT07256327

Brief Summary

The main aim of this pilot observational study is 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 sensory processing disorder (SPD). The secondary aim is to assess potential changes in objective and subjective outcomes.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
8mo left

Started Feb 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress24%
Feb 2026Jan 2027

First Submitted

Initial submission to the registry

November 20, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 1, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

February 16, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2027

Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

11 months

First QC Date

November 20, 2025

Last Update Submit

March 3, 2026

Conditions

Keywords

PediatricsChiropracticAutonomic Nervous SystemPilot ProjectsSensation DisordersNeurodevelopmental Disorders

Outcome Measures

Primary Outcomes (4)

  • Proportion of enrollees who are eligible to participate

    The number of enrollees (i.e., participants who consent/assent) who score ≤154 on the baseline Short Sensory Profile (SSP), divided by the total number of enrollees. This assesses 'Eligibility'.

    From enrollment to baseline SSP score evaluation (up to 1 hour)

  • Proportion of participants able to tolerate the assessments

    The number of participants able to complete all baseline assessments as directed, divided by the total number of participants. This assesses 'Tolerability'.

    From enrollment to baseline assessment completion (up to 1 hour)

  • Proportion of participants adhering to the recommended care plan

    The number of participants attending 15 sessions of chiropractic care within 10 weeks, divided by the total number of participants. This assesses 'Adherence'.

    From enrollment to the end of participation (up to 10 weeks)

  • Proportion of participants retained in the study

    The number of participants attending the 3rd and final assessment session, divided by the total number of participants. This assesses 'Retention'.

    From enrollment to the end of the 10 week study period.

Secondary Outcomes (4)

  • Change in Heart Rate Variability (HRV)

    From enrollment to the end of participation (up to 10 weeks)

  • Change in Bilaterial Weight Distribution

    From enrollment to the end of participation (up to 10 weeks)

  • Change in Short Sensory Profile (SSP) Scores

    From enrollment to the end of participation (up to 10 weeks)

  • Change in Pediatric Autonomic Symptom Scales (PASS) Scores

    From enrollment to the end of participation (up to 10 weeks)

Study Arms (1)

Children (5-12) with SPD-Related Symptoms

Children aged 5-12 years whose parents/caregivers identify the presence of symptoms associated with sensory processing disorder (SPD). A formal clinical diagnosis is not required for inclusion.

Interventions

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children aged 5-12 years whose parents/caregivers identify the presence of symptoms associated with sensory processing disorder (SPD). A formal clinical diagnosis is not required for inclusion.

You may qualify if:

  • years of age.
  • SSP total scores ≤154

You may not qualify if:

  • A known heart condition, including pacemakers
  • Chiropractic care within the past 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rubin Family Chiropractic

Marietta, Georgia, 30067, United States

Location

MeSH Terms

Conditions

Sensation DisordersNeurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Tyson Perez, DC, PhD

    Life University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

November 20, 2025

First Posted

December 1, 2025

Study Start

February 16, 2026

Primary Completion (Estimated)

January 15, 2027

Study Completion (Estimated)

January 15, 2027

Last Updated

March 6, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Deidentified IPD necessary to reproduce results.

Shared Documents
ANALYTIC CODE
Time Frame
(start date): within 1 year of study completion. (end date): indefinitely
Access Criteria
IPD, metadata \& analytic code necessary to reproduce results will be made publicly accessible via a data repository
More information

Locations