Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001448437
Ethics application status
Approved
Date submitted
23/03/2016
Date registered
17/10/2016
Date last updated
12/02/2021
Date data sharing statement initially provided
12/02/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of a single chiropractic session on the control of eye movement in children with Attention Deficit Hyperactivity Disorder
Scientific title
Chiropractic intervention and the control of eye movement in children with attention deficit hyperactivity disorder: A pilot study.
Secondary ID [1] 288829 0
Nil
Universal Trial Number (UTN)
U1111-1181-1786
Trial acronym
ADHDCHIRO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ADHD - Attention Deficit Hyperactivity Disorder 298107 0
Oculomotor function 298108 0
Condition category
Condition code
Neurological 298275 298275 0 0
Other neurological disorders
Mental Health 298536 298536 0 0
Other mental health disorders
Eye 298537 298537 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participant intervention: Participants will receive two assessment sessions. Depending on which group (intervention or active control) they will receive one of the two following sessions. They will have a one-week washout period, and then return for the remaining session
Intervention session: Participants will receive a chiropractic assessment and spinal manipulation where deemed appropriate. Assessment includes; orthopedic testing, neurological testing, manual palpation of the spine and range of motion of the spine. The spinal manipulation involves a high speed, very low amplitude manual force to be applied to a specific spinal joint. Specific spinal joints are manipulated on the basis of aberrant findings from the assessment
Active control session: where the body is moved through various positions to provide motion and vestibular input, but no chiropractic manipulation/adjustment input
Attending Chiropractor: Registered chiropractor with at least 10yrs experience and postgraduate training in pediatrics.
Session duration: approximately 60minutes
Strategies for adherence: The study will be discussed at the weekly meeting of the executive team at the Centre for Chiropractic Research. Any issue with adherence will be discussed at, or between, these meetings so appropriate action can be taken. If action needs to be taken the co-investigator with attempt to contact the participant/guardian by their preferred contact modality.
Intervention code [1] 294284 0
Treatment: Other
Comparator / control treatment
Children will undergo a series of passive and active movements of the head, spine, and body carried out by the same chiropractor that assesses the experimental intervention group. This control intervention involves the participants being moved into the manipulation setup positions but without delivering an adjustment/manipulation thrust into any spinal joints. No spinal manipulation will be performed during any control. This control intervention is not intended to act as a sham manipulation but to act as a physiological control for possible changes occurring due to the cutaneous, muscular or vestibular input that will occur with the passive and active movements involved in preparing a participant for a manipulation.
Control group
Active

Outcomes
Primary outcome [1] 297760 0
Composite oculomotor data (target acquisition, number and length of fixations, number of forward and reverse saccades). assessed during a computer-based reading task by a Tobii computerised eye-tracking device.
Timepoint [1] 297760 0
Session 1: Baseline and immediately post either chiropractic session or active control for control-group.

Then; 1-week wash-out period

Session 2: Baseline and immediately post either chiropractic session or active control for control-group.
Secondary outcome [1] 322960 0
Total time to completion of reading task, assessed during a computer-based reading task by a Tobii computerised eye-tracking device.
Timepoint [1] 322960 0
Session 1: Baseline and immediately post either chiropractic session or active control for control-group.

Then; 1-week wash-out period

Session 2: Baseline and immediately post either chiropractic session or active control for control-group.

Eligibility
Key inclusion criteria
Children ages 8-15 with ADHD
Minimum age
8 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Major visual disabilities that prevent reading.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Computer generated block randomization sequence by the online QMinim program. Allocation will be concealed by sealed opaque envelopes .
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated block randomization sequence by the online QMinim program
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A multifactorial repeated measure ANOVA will also be used to assess for within subject differences.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
14/10/2016
Date of last participant enrolment
Anticipated
Actual
5/01/2017
Date of last data collection
Anticipated
Actual
5/01/2017
Sample size
Target
30
Accrual to date
Final
30
Recruitment outside Australia
Country [1] 7733 0
New Zealand
State/province [1] 7733 0
Auckland

Funding & Sponsors
Funding source category [1] 293192 0
University
Name [1] 293192 0
Auckland University of Technology
Country [1] 293192 0
New Zealand
Primary sponsor type
Other Collaborative groups
Name
New Zealand College of Chiropractic
Address
6 Harrison Road
Mt Wellington
Auckland 1071
New Zealand
Country
New Zealand
Secondary sponsor category [1] 291988 0
None
Name [1] 291988 0
Address [1] 291988 0
Country [1] 291988 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294679 0
Health and Disability Ethics Committee
Ethics committee address [1] 294679 0
Ethics committee country [1] 294679 0
New Zealand
Date submitted for ethics approval [1] 294679 0
28/03/2016
Approval date [1] 294679 0
02/08/2016
Ethics approval number [1] 294679 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64546 0
Dr Kelly Jones
Address 64546 0
Auckland University of Technology
Faculty of Health & Environmental Sciences
National Institute for Stroke and Applied Neurosciences
Private Bag 92006
Auckland 1142
Country 64546 0
New Zealand
Phone 64546 0
+64 7 838 4257
Fax 64546 0
Email 64546 0
[email protected]
Contact person for public queries
Name 64547 0
Alice Cade
Address 64547 0
New Zealand College of Chiropractic
6 Harrison Road
Mt Wellington
Auckland
1071
Country 64547 0
New Zealand
Phone 64547 0
+6495266789
Fax 64547 0
Email 64547 0
[email protected]
Contact person for scientific queries
Name 64548 0
Alice Cade
Address 64548 0
New Zealand College of Chiropractic
6 Harrison Road
Mt Wellington
Auckland
1071
Country 64548 0
New Zealand
Phone 64548 0
+6495266789
Fax 64548 0
Email 64548 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10664Study protocol https://openrepository.aut.ac.nz/handle/10292/10820 



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe effects of spinal manipulation on oculomotor control in children with attention deficit hyperactivity disorder: A pilot and feasibility study.2021https://dx.doi.org/10.3390/brainsci11081047
N.B. These documents automatically identified may not have been verified by the study sponsor.