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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 (i.e., RMSSD). | From enrollment to the end of participation (up to 10 weeks) |
| Change in Short Sensory Profile (SSP) Scores |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Research Programs & Grants Administrator | Contact | 678-331-4527 | angela.seckington@life.edu |
| Name | Affiliation | Role |
|---|---|---|
| Tyson Perez, DC, PhD | Life University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Well Adjusted Students | Chippewa Falls | Wisconsin | 54729 | United States |
Deidentified IPD necessary to reproduce results.
(start date): within 1 year of study completion. (end date): indefinitely
IPD, metadata & analytic code necessary to reproduce results will be made publicly accessible via a data repository
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| ID | Term |
|---|---|
| D012678 | Sensation Disorders |
| D065886 | Neurodevelopmental Disorders |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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. |
| From enrollment to the end of participation (up to 10 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. | From enrollment to the end of participation (up to 10 weeks) |
| D001523 | Mental Disorders |