Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06413719
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-05-09
Brief Title:
Assessing the Effects of Chiropractic Care in Children With Parent-reported Sensory Processing Disorder
Sponsor:
Life University
Organization:
Life University
Study Overview
Official Title:
Assessing the Effects of Chiropractic Care in Children With Parent-reported Sensory Processing Disorder a Feasibility Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPD
Brief Summary:
This trials 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
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 clinics 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 eg yes I would like to do the study andor physically eg 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 childs access to normal and customary chiropractic care
Children will be asked to stand up straight on a scale so we 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 ie 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 iPhoneiPad 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 v741 is presented to both ears through the headphones for 2 minutes The sound is like what you 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 eg 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 hisher hand from the neuroPULSE scanner During the childs 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 PWCs normal and customary chiropractic care
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 clinics 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 eg yes I would like to do the study andor physically eg 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 childs access to normal and customary chiropractic care
Children will be asked to stand up straight on a scale so we 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 ie 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 iPhoneiPad 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 v741 is presented to both ears through the headphones for 2 minutes The sound is like what you 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 eg 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 hisher hand from the neuroPULSE scanner During the childs 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 PWCs normal and customary chiropractic care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None