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Trial registered on ANZCTR


Registration number
ACTRN12616001720404
Ethics application status
Approved
Date submitted
6/12/2016
Date registered
14/12/2016
Date last updated
24/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of chiropractic care on sensory integration in children with autism.
Scientific title
Can chiropractic adjustments change multisensory integration and sensorimotor integration in children with autism? A pilot study.
Secondary ID [1] 290630 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism spectrum disorder 301147 0
Asperger's Syndrome 301148 0
Condition category
Condition code
Mental Health 300909 300909 0 0
Autistic spectrum disorders
Physical Medicine / Rehabilitation 300910 300910 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single session of high-velocity, low amplitude, spinal manipulative therapy performed by a registered chiropractor in Auckland, New Zealand at the Centre for Chiropractic Research or at another suitable location. The intervention will involve assessing the full spine for any dysfunctional spinal segments and using spinal manipulation where necessary, this intervention will be pragmatic in style to best replicate chiropractic practice. The intervention session will take approximately 10-15 minutes.
Intervention code [1] 296507 0
Treatment: Other
Comparator / control treatment
Passive spinal range of motion will be used for the control group, performed by a chiropractor. This is aimed to mimic the full spine assessment and positional set up for chiropractic spinal manipulation, to control for any changes that may result simply from movement of the spine and tactile stimulation. This session will be less than 10 minutes.
Control group
Active

Outcomes
Primary outcome [1] 300319 0
The primary outcome measures will be data collected that relates to all study processes. Feasibility will be assessed by a composite of: recruitment rates, randomisation, percentage rate of completion of tasks for pre and post assessment measures and time taken to complete the protocol.

As the intervention will only be a single session, there will not be a need to measure compliance rates with the intervention, as participants will not be required to do any follow up.
Timepoint [1] 300319 0
Baseline and throughout all study processes
Secondary outcome [1] 329674 0
Performance on a sound-induced flash illusion task using a custom built Macroderma Sound-Induced Flash Illusion System. This task is used to measure multisensory integration by assessing how susceptible the individual is to experiencing the illusion. Where a greater susceptibility reflects poorer multisensory integration.
Timepoint [1] 329674 0
Baseline and post-intervention on the same day
Secondary outcome [2] 329675 0
The bilateral manual co-ordination subscale of the Sensory Integration and Praxis Tests will be used to assess vestibular and proprioceptive processing. This involves reproducing co-ordinated movements of the upper and lower limbs as demonstrated by a research assistant, this will be video and audio recorded and scored based on how well the child replicated the movements.
Timepoint [2] 329675 0
Baseline and post-intervention on the same day
Secondary outcome [3] 329676 0
Fine motor skills assessed by threading beads onto a string, This is a timed activity.
Timepoint [3] 329676 0
Baseline and post-intervention on the same day
Secondary outcome [4] 329677 0
Fine motor skills assessed by tracing an outline of a shape on a touch-screen tablet using a stylus, A computer program will measure deviation away from line and time taken to complete task.
Timepoint [4] 329677 0
Baseline and post-intervention on the same day
Secondary outcome [5] 330054 0
Localisation of tactile stimuli is the second subscale of the Sensory Integration and Praxis tests that will be use to measure tactile proprioceptive awareness. While blind-folded the child will be asked to locate a point on the hand or arm with their finger where a research assistant has touched. The points will be marked and then the distance between the target and response points will be measured.
Timepoint [5] 330054 0
Baseline and post-intervention on the same day
Secondary outcome [6] 330055 0
Kinaesthesia is the third of the Sensory Integration and Praxis tests that will be used, this will assess tactile proprioceptive awareness. While the child's blind-folded, the research assistant will place the child's finger on a specific location on the desk and orientate the child to this spot. The research assistant will then move the child's finger to a second location, asking the child to be aware of how it feels to "move" to this new spot. After approximately 3 seconds, the research assistant will return the child's finger to the first location and then ask them to return the finger to the second location.
Timepoint [6] 330055 0
Baseline and post-intervention on the same day

Eligibility
Key inclusion criteria
High-functioning autism (HFA) or Asperger’s Syndrome (AS) confirmed by parental report, and verbal.
Participants will also be screened with the following question, to determine if the child may have issues with sensory processing: “Does your child struggle to cope in environments where there is a lot going on? E.g. environments that are loud/noisy, busy and/or bright?” A ‘yes’ to this question will result in inclusion and a ‘no’ will result in exclusion from the study.
Minimum age
6 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
non-verbal; hearing or vision impairments; specific reading disorder (such as dyslexia) or genetic disorder (e.g. tuberous sclerosis); or a history of seizures or traumatic brain injury

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)
Allocation will be concealed as participants will be randomised using online computer software after baseline measures are taken.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Similar to other studies, a sample of 30 participants will allow us to assess the feasibility aspects of the study and to calculate potential effect sizes
After data cleaning, assuming normality, paired t-tests will examine between group differences on each outcome measure. In any instances where normality is not maintained, a Wilcoxon Signed Rank Test will be used. Effect sizes (Eta squared) will inform sample size calculations for a full-scale clinical trial. Descriptive statistics will assess the feasibility of key study processes, including completion rates, time taken to complete the entire selection of tasks and recruitment. Significance will be set at P = .05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/02/2017
Actual
20/09/2017
Date of last participant enrolment
Anticipated
Actual
31/05/2018
Date of last data collection
Anticipated
Actual
15/06/2018
Sample size
Target
30
Accrual to date
Final
8
Recruitment outside Australia
Country [1] 8417 0
New Zealand
State/province [1] 8417 0
Auckland

Funding & Sponsors
Funding source category [1] 295060 0
Other Collaborative groups
Name [1] 295060 0
College of Chiropractic Neurodevelopmental Paediatrics
Country [1] 295060 0
Australia
Funding source category [2] 295061 0
Other Collaborative groups
Name [2] 295061 0
The Kids Summit
Country [2] 295061 0
Australia
Funding source category [3] 295062 0
Other Collaborative groups
Name [3] 295062 0
Centre for Chiropractic Research
Country [3] 295062 0
New Zealand
Primary sponsor type
University
Name
Auckland University of Technology
Address
55 Wellesley St E, Auckland, 1010
Country
New Zealand
Secondary sponsor category [1] 293875 0
None
Name [1] 293875 0
Address [1] 293875 0
Country [1] 293875 0
Other collaborator category [1] 279324 0
Other Collaborative groups
Name [1] 279324 0
Centre for Chiropractic Research
Address [1] 279324 0
6 Harrison Rd,
Mount Wellington,
Auckland 1060
Country [1] 279324 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296460 0
Health and Disability Ethics Committee
Ethics committee address [1] 296460 0
Ethics committee country [1] 296460 0
New Zealand
Date submitted for ethics approval [1] 296460 0
16/12/2016
Approval date [1] 296460 0
28/07/2017
Ethics approval number [1] 296460 0
17/NTA/58

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

Contacts
Principal investigator
Name 70790 0
Dr Kelly Jones
Address 70790 0
National Institute for Stroke and Applied Neurosciences (mail code A-11)
AUT University
Private Bag 92006
Auckland 1142
New Zealand
Country 70790 0
New Zealand
Phone 70790 0
+64 212460587
Fax 70790 0
Email 70790 0
[email protected]
Contact person for public queries
Name 70791 0
Kelly Jones
Address 70791 0
National Institute for Stroke and Applied Neurosciences (mail code A-11)
AUT University
Private Bag 92006
Auckland 1142
New Zealand
Country 70791 0
New Zealand
Phone 70791 0
+64 9 921 9999
Fax 70791 0
Email 70791 0
[email protected]
Contact person for scientific queries
Name 70792 0
Kelly Jones
Address 70792 0
National Institute for Stroke and Applied Neurosciences (mail code A-11)
AUT University
Private Bag 92006
Auckland 1142
New Zealand
Country 70792 0
New Zealand
Phone 70792 0
+64 9 921 9999
Fax 70792 0
Email 70792 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.