The Effects of Chiropractic Care in Children With Parent-reported Sensory Processing Disorder

NCT06413719 | Withdrawn

• 1 other identifier: I-0030
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sensation Disorders

Keywords

Pediatrics; sensation disorders; autonomic nervous system; HRV; heart rate variability

Outcome Measures

Primary Outcomes (6)

• Recruitment rate

  Average number of subjects enrolled per month

  3 months (recruitment period)

• Proportion of participants able to complete assessments

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

  4 months (data collection period)

• Adherence

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

  4 months (data collection period)

• Retention

  % of participants completing the trial

  4 months (data collection period)

• Efficiency

  Average time to completion of each assessment section

  4 months (data collection period)

• Data quality

  % of acquisitions unsuitable for analysis for a given assessment

  6 months (study period)

Study Arms (1)

No Intervention

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

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Life University: lead

MeSH Terms

Conditions

Sensation Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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: May 9, 2024
• First Posted: May 14, 2024
• Study Start: October 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: July 1, 2025
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)