Chiropractic for Kids With Sensory Processing Challenges
ConditionSensory Processing Disorder
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age5-12
SponsorLife University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
5-12 years of age.
SSP total scores ≤154
Disqualifiers
A known heart condition, including pacemakers
Chiropractic care within the past 30 days
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
20 Participants
are grouped into 1 trial groupGroup A: Children (5-12) with SPD-Related Symptoms
Trial outcomes
Primary outcomes
1
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'.
Time frame
From enrollment to baseline SSP score evaluation (up to 1 hour)2
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'.
Time frame
From enrollment to baseline assessment completion (up to 1 hour)3
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'.
Time frame
From enrollment to the end of participation (up to 10 weeks)4
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'.
Time frame
From enrollment to the end of the 10 week study period.Secondary outcomes
1
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).
Time frame
From enrollment to the end of participation (up to 10 weeks)2
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 10 weeks)3
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 10 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: