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Sensation DisordersNCT06413719

The Effects of Chiropractic Care in Children With Parent-reported Sensory Processing Disorder

An observational study of Sensation Disorders, run by Life University.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This trial's main aims 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. Read more about this study

Who is it for?
Ages 5 to 12 years
Conditions the study is for
Sensation Disorders
How many people
0 participants
Where
No sites listed yet
Study dates
1 Oct 2024to 1 Jul 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: Children with probable or definite sensory processing challenges per the SSP-1

Who may be able to join

  • 5-12 years of age
  • SSP-1 total score no greater than 154

Who cannot join

  • Unable to perform assessments due to vision, hearing, or movement impairment (e.g., blind, deaf, confined to wheelchair)
  • Unable to perform the assessments due to a preexisting condition whereby quick postural changes are contraindicated (e.g., postural orthostatic tachycardia syndrome (POTS), postural hypotension)
  • Pacemaker or known heart condition that influences the electrical or mechanical function of the heart

About this study

Official title: The Effects of Chiropractic Care in Children With Parent-reported Sensory Processing Disorder: a Pilot Observational Study

This trial's main aims 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. More specifically, our primary endpoints are 1) recruitment rate, 2) tolerability, 3) adherence, 4) retention, 5) efficiency, and 6) data quality.

Read the detailed description

The total estimated time requirement for this study is ~60 minutes.

Up to 20 children (ages 5-12) will be recruited in a maximum 3-month enrollment period. The total estimated time requirement for the parent and child is ~1 hour excluding the normal and customary chiropractic care. Per the clinic's normal and customary procedures, a welcome email is sent to each parent who schedules their child for a chiropractic exam at Premier Wellness Care (PWC) chiropractic (Crystal Lake, IL). An addendum will be added to this email briefly introducing the study along with a HIPAA compliant Jotform link to an online screening survey which incorporates the 38-item short sensory profile v1 (SSP-1). Those who complete the online screen and meet the eligibility criteria described below will be notified when they arrive at PWC for their initial exam \& offered the opportunity to participate in the study.

Informed consent (IC) and assent (IA) will be collected in a private room within PWC. A PWC staff member (TM) will sit down with each parent \& child to review the IC \& IA forms and answer any queries. To be enrolled, the parent must sign the IC and the child must acknowledge their willingness to participate verbally (e.g., "yes I would like to do the study") and/or physically (e.g., nod their head \& give a 'thumbs up'). It will be made clear to all parents \& children that they may decline participation without penalty and declining participation will in no way impact the child's access to normal and customary chiropractic care.

Children will be asked to stand up straight on a scale so the investigators can measure their heights and weights. They will then be asked to sit in a comfortable chair, shown a visual analog scale (VAS), and asked to rate their pain level on a scale from 0 ("no pain") to 10 ("worst pain possible").

To track autonomic nervous system (ANS) activity, children will be asked to place their hand on the class II FDA registered neuroPULSE scanner (CLA Inc., Toronto, ON, Canada) and put their index, middle, \& ring fingers onto the sensors. To track sweat gland (i.e., electrodermal, EDA) activity, a safe and unrecognizable low-voltage, high-amplitude current is passed between sensors located at the palmar-surfaces of the index and ring fingers. The pulse rate is measured via photoplethysmography (PPG) whereby blood flow-dependent changes in the quantity of emitted light passing though the fingertip are tracked via a sensor located on the palmar-surface of the middle finger. All signals will be transmitted to an iPad for viewing by the assessor via a secure Wi-Fi connection.

With their hand in the neuroPULSE, children will undergo a sensory challenge protocol (SCP). For the SCP, the kids will be fitted with noise cancelling headphones and be shown a series of pictures. Prior to initiating the SCP, the assessor will instruct the child how to perform the test. The headphones will then be paired via Bluetooth to an iPhone/iPad device \& switched on. Upon presentation of the "sitting" picture, the child will be asked to sit still and quietly for ~2 minutes. Upon presentation of the "standing" picture, they will be asked to quickly stand and remain still and quiet for ~2 minutes. Upon re-presentation of the "sitting" picture, the child will be asked to quickly return to a seated position \& remain still and quiet for ~2 minutes. Finally, upon presentation of the "noise" picture, the child will be asked to sit still and quietly while an auditory stimulus (1000 Hz, sine wave, 50% system volume, ~75 dB) generated via a free tone generator app (f Generator, v7.4.1) is presented to both ears through the headphones for ~2 minutes. The sound is like what someone would hear on your mobile device during an "AMBER Alert". This prolonged auditory stimulus is well below acceptable noise exposure limits and is in line with a protocol used in prior studies to test pediatric SPD populations. To help keep the children occupied during the SCP, a researcher will place an iPad directly in front of the subject \& play a relaxing video (e.g., fish swimming in the ocean). When the SCP is finished, the video will be stopped, the headphones will be removed, and the child will be asked to remove his/her hand from the neuroPULSE scanner. During the child's assessment, parents will then be given an iPad \& asked to complete the 38-item SSP-1.

All assessments will be repeated following 12 sessions of PWC's normal and customary chiropractic care.

Keywords
Pediatrics, sensation disorders, autonomic nervous system, HRV, heart rate variability
Medical subject headings
Sensation Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06413719
Study groupRoleWhat they receive
No InterventionChildren with probable or definite sensory processing challenges per the SSP-1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment rate

    Average number of subjects enrolled per month

    Measured: 3 months (recruitment period)

  2. Proportion of participants able to complete assessments

    Proportion of participants unable/unwilling to complete a given assessment as directed. This assesses 'Tolerability'.

    Measured: 4 months (data collection period)

  3. Adherence

    % of participants attending <80% of their chiropractic sessions within the recommended time frame

    Measured: 4 months (data collection period)

  4. Retention

    % of participants completing the trial

    Measured: 4 months (data collection period)

  5. Efficiency

    Average time to completion of each assessment section

    Measured: 4 months (data collection period)

  6. Data quality

    % of acquisitions unsuitable for analysis for a given assessment

    Measured: 6 months (study period)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2024
  2. Study start1 Oct 2024 (estimated)
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion1 Jul 2025 (estimated)

Why it stopped: Change in study location and investigators

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06413719
Sponsor's protocol ID
I-0030
Status last verified
Feb 2026
First submitted
9 May 2024
Last updated
2 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Sensation Disorders, run by Life University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment rate (time frame: 3 months (recruitment period)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.

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