Sensory Processing Disorder
Conditions
Keywords
Pediatrics, Chiropractic, Autonomic Nervous System, Pilot Projects, Sensation Disorders, Neurodevelopmental Disorders
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.
Detailed description
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.
Interventions
None listed
Sponsors
Life University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of students enrolled | From online screen submission to consent (up to 4 weeks) | Number of students enrolled, divided by the total number of eligible students identified via the online screen. This assesses 'Enrollment' |
| Proportion of completed assessment sessions | From enrollment to end of trial participation (up to 12 weeks) | The number of completed ECG sessions, divided by the total number of scheduled ECG sessions (excludes sessions scheduled after withdrawal). This assesses 'Compliance' |
| Proportion of students adhering to the care plan | From enrollment to the end of participation (up to 12 weeks) | 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'. |
| Proportion of students retained | From enrollment to the end of the 12 week study period. | The number of participants attending the final ECG session, divided by the total number of students enrolled. This assesses 'Retention'. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Heart Rate Variability (HRV) | From enrollment to the end of participation (up to 12 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. |
| Change in Short Sensory Profile (SSP) Scores | From enrollment to the end of participation (up to 12 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. |
| Change in Pediatric Autonomic Symptom Scales (PASS) Scores | From enrollment to the end of participation (up to 12 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTyson Perez, DC, PhD
Life University
CONTACTResearch Programs & Grants Administrator
Outcome results
None listed