Sensory Processing Challenges: a Pilot Observational Study (SPD)

Life University

Status: Not yet enrolling

Conditions: Sensory Processing Disorder

Treatments: Other: Chiropractic Care

Study type: Interventional

Funder types: Other

Identifiers

NCT07256327

I-0036

Details and patient eligibility

About

The main aims of this pilot observational study 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.

Full description

Twenty (20) children with probable or definite parent-reported SPD (i.e., Short Sensory Profile (SSP) total scores ≤154) will be enrolled. More specifically, our primary outcomes are 1) enrollment, 2) tolerability, 3) adherence, and 4) retention. Secondary aims involve assessing the potential effects of subluxation-based chiropractic care on electrocardiography (ECG)-derived heart rate variability (HRV), bilateral weight distribution (BWD), and parent-reported outcomes (PROs). Data from this study will inform our lab regarding the feasibility of a larger study powered to assess the effectiveness of pediatric chiropractic care on clinical outcomes in a pediatric population with SPD.

Enrollment: 20 estimated patients

Sex: All

Ages: 5 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Intervention Group

Experimental group

Description:

15 sessions of pediatric chiropractic care

Treatment:

Other: Chiropractic Care