An observational study in Sensory Processing Disorder, sponsored by Life University. Not yet recruiting at 1 site in United States. Open to participants aged 5 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Life University · Observational
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.
Up to 17 students 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.
87 studies on the registry are indexed under Sensation Disorders; 23 are open to participants now.
This study's planned enrollment of 17 is below the median of 58 across 25 observational studies indexed under Sensation Disorders.
Browse Sensation Disorders studies →Life University is the lead sponsor of 29 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Proportion of students enrolled
Number of students enrolled, divided by the total number of eligible students identified via the online screen. This assesses 'Enrollment'
Time frame: From online screen submission to consent (up to 4 weeks)
Proportion of completed assessment sessions
The number of completed ECG sessions, divided by the total number of scheduled ECG sessions (excludes sessions scheduled after withdrawal). This assesses 'Compliance'
Time frame: From enrollment to end of trial participation (up to 12 weeks)
Proportion of students adhering to the care plan
The number of students attending at least 90% of their scheduled chiropractic care sessions, divided by the total number of students enrolled (excludes sessions schedule after withdrawal). This assesses 'Adherence'.
Time frame: From enrollment to the end of participation (up to 12 weeks)
Proportion of students retained
The number of participants attending the final ECG session, divided by the total number of students enrolled. This assesses 'Retention'.
Time frame: From enrollment to the end of the 12 week study period.
Change in Heart Rate Variability (HRV)
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.
Time frame: From enrollment to the end of participation (up to 12 weeks)
Change in Short Sensory Profile (SSP) Scores
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.
Time frame: From enrollment to the end of participation (up to 12 weeks)
Change in Pediatric Autonomic Symptom Scales (PASS) Scores
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.
Time frame: From enrollment to the end of participation (up to 12 weeks)
Plan to share: Yes — Deidentified IPD necessary to reproduce results.
Supporting information: 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
Data sharing details ↗ · figshare.com
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Dec 2026, 4 months later.
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This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Life University