- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07256327
Chiropractic for Kids With Sensory Processing Challenges (SPD)
May 4, 2026 updated by: Tyson Perez, DC, PhD, Life University
The Effects of Chiropractic on Kids With Sensory Processing Challenges: a Pilot Observational Study
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Twenty (20) parents & children with probable or definite parent-reported SPD as determined by the Short Sensory Profile (SSP) will be enrolled.
The primary outcomes are 1) eligibility, 2) tolerability, 3) adherence, and 4) retention.
The secondary aim is to assess the potential effects of subluxation-based pediatric chiropractic care on electrocardiography (ECG)-derived heart rate variability (HRV) and parent-reported outcomes (PROs).
Results from this study will inform the feasibility of a larger study powered to assess the effectiveness of pediatric chiropractic care on clinical outcomes in a pediatric population with SPD.
Study Type
Observational
Enrollment (Estimated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Research Programs & Grants Administrator
- Phone Number: 678-331-4527
- Email: angela.seckington@life.edu
Study Locations
-
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Wisconsin
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Chippewa Falls, Wisconsin, United States, 54729
- Well Adjusted Students
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Sampling Method
Non-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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of enrollees who are eligible to participate
Time Frame: From enrollment to baseline SSP score evaluation (up to 1 hour)
|
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'.
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From enrollment to baseline SSP score evaluation (up to 1 hour)
|
|
Proportion of participants able to tolerate the assessments
Time Frame: From enrollment to baseline assessment completion (up to 1 hour)
|
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
Time Frame: From enrollment to the end of participation (up to 10 weeks)
|
The number of participants attending 15 sessions of chiropractic care within 10 weeks, divided by the total number of participants.
This assesses 'Adherence'.
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From enrollment to the end of participation (up to 10 weeks)
|
|
Proportion of participants retained in the study
Time Frame: From enrollment to the end of the 10 week study period.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Heart Rate Variability (HRV)
Time Frame: From enrollment to the end of participation (up to 10 weeks)
|
Change in resting-state heart rate variability (HRV) from baseline.
Children will undertake 3 minutes of electrocardiography (ECG) while seated.
ECG data will be used to derive HRV (i.e., RMSSD).
|
From enrollment to the end of participation (up to 10 weeks)
|
|
Change in Short Sensory Profile (SSP) Scores
Time Frame: From enrollment to the end of participation (up to 10 weeks)
|
Change in SSP scores from baseline.
The SSP is a 38-item parent-report designed to assess a child's responsiveness to sensory stimuli including tactile sensitivity, taste/smell sensitivity, and visual/auditory sensitivity.
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From enrollment to the end of participation (up to 10 weeks)
|
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Change in Pediatric Autonomic Symptom Scales (PASS) Scores
Time Frame: From enrollment to the end of participation (up to 10 weeks)
|
Change in PASS scores from baseline.
The PASS is an 80-item parent-report questionnaire designed to assess autonomic function in children across four main subscales: 1) mood, behavior, and emotion; 2) secretomotor/sensory integration; 3) urinary/gastrointestinal systems; 4) circulation, thermoregulation, sleep, and breathing.
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From enrollment to the end of participation (up to 10 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tyson Perez, DC, PhD, Life University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
August 1, 2026
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
November 20, 2025
First Submitted That Met QC Criteria
November 20, 2025
First Posted (Actual)
December 1, 2025
Study Record Updates
Last Update Posted (Actual)
May 8, 2026
Last Update Submitted That Met QC Criteria
May 4, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EXPTP011226
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Deidentified IPD necessary to reproduce results.
IPD Sharing Time Frame
(start date): within 1 year of study completion.
(end date): indefinitely
IPD Sharing Access Criteria
IPD, metadata & analytic code necessary to reproduce results will be made publicly accessible via a data repository
IPD Sharing Supporting Information Type
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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