Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000953538
Ethics application status
Approved
Date submitted
19/08/2015
Date registered
10/09/2015
Date last updated
6/09/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of chiropractic care on mental rotation in children
Scientific title
The effect of a single intervention of chiropractic on mental rotation ability in children aged 5-12 yrs; a standard parallel randomised control trial
Secondary ID [1] 287243 0
Nil Known
Universal Trial Number (UTN)
U1111-1171-6413
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Assessment of prefrontal lobe function 295851 0
Assessment of parietal lobe function 296065 0
Condition category
Condition code
Alternative and Complementary Medicine 296107 296107 0 0
Other alternative and complementary medicine
Physical Medicine / Rehabilitation 296329 296329 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mental rotation test before and then after a single intervention of chiropractic adjustment (manipulation) to consenting children aged 5-12 years, who are current patients of participating chiropractic practices in Auckland, New Zealand.
a) chiropractic adjustment includes both High Velocity Low Amplitude thrust (HVLA) modified for the age of each presenting patient. So lower thrust and speed for younger children which gradually increases for those children aged 10-12 years; and low force low speed adjustments including cranial therapy, mobilisation, touch and hold.
b) Specific locations will be determined by the chiropractor according to the location of fixated joints at the time of the intervention. A record will be kept of the location of the spinal segment treated (upper of lower cervicals, thoracics, lumbars) and the type of thrust (HVLA or Low force/low speed).
c) There will be one session of intervention, which will include as many areas of treatment application as deemed necessary by the chiropractor providing treatment. This will be based on the number of fixated joints found in each child at the time of the assessment. (Most commonly 3-4 areas each requiring one application in one intervention of chiropractic treatment.
d) Approximate duration of chiropractic session 10 minutes.
e) Adherence will be monitored by the Research Assistant who will collect notes of each intervention provided by the chiropractor at the time of completion of both mental rotation test of each participant.
Intervention code [1] 292532 0
Treatment: Other
Comparator / control treatment
Control group of children aged 5-12 years who have consented to participate in the study and are current chiropractic patients.
Randomly selected control group of equal numbers of children in treatment group to perform mental rotation test, undergo Sham treatment with the chiropractor (spine palpation) and then perform the mental rotation test a second time.
The research assistant performing mental rotation test will be blinded to whether participants are in the control or treatment group.
Control group
Placebo

Outcomes
Primary outcome [1] 295778 0
Proportion of participants achieving a decrease in mental rotation time, using Inquisit 4 paper folding mental rotation task.
Timepoint [1] 295778 0
Mental rotation is tested at baseline and then immediately after a single trial of chiropractic treatment or sham treatment.
Secondary outcome [1] 316507 0
Do different chiropractic treatment applications affect mental rotation time in the target population?
Mental rotation will be tested using the inquisit 4 paper folding mental rotation test.
Timepoint [1] 316507 0
Assessed at baseline and then immediately after the application of chiropractic or sham treatment.

Eligibility
Key inclusion criteria
Participating practitioners: Chiropractors who practice in the Auckland Region of NZ and treat more than 50 children per month aged 5-12 years.
Participating children: Healthy current patients of participating chiropractic practices in the Auckland Region, aged 5-12 years, who have do not have colour blindness, known dyslexia.
Minimum age
5 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded from the study if they have known colour blindness, dyslexia, autism, a previous or current neurological disease, or a pathology that would exclude treatment or that would be an absolute or relative contraindication to spinal manipulative therapy.
Non completed tests will be tabulated in the results section. Drop out rate as well as reasons for drop out will be recorded and discussed.

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)
A short description of study will be provided to reception staff at participating practices. Parents invited to have their child participate in the study by the practice receptionist at the time of booking their appointment with the practitioner.
Consenting children will be randomised on presentation to the participating chiropractic practice, into control and treatment groups by the receptionist at the practice
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation: Consenting child participants will be randomly allocated to the control or treatment group. Equal numbers of control and intervention labels will be individually placed into sealed opaque envelopes by the research assistant. Equal numbers of each group will be brought to each location and shuffled by the research assistant, who will give an envelope to each child after the first test. The child will hand the envelope to the chiropractor who will be the only person who reads what group the child is in. This will enable the chiropractor to know whether to conduct a sham or real treatment with the child. The research assistant will be blind to which group participants are in.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Blinding: Participant’s will be ‘blinded’ to which group they are in. The Research Assistant will also be blinded to whether participants are in the control or treatment group as a result of the randomisation process. Only the chiropractor will be aware of group type.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Power analysis performed based on previous adult studies using 40 treatment and 40 control participants where a statistically significant difference in treatment and control groups was determined.
A sample size of 50 in each group was determined, and an extra 10 in each group at the beginning of the study to allow for dropout.
Power analysis included statistical significance of P<0.05 with an effect of greater than 2 standard deviations in a group of 40 adults in previous studies using one technique in one region of the spine.
This study will involve either HVLA or low force techniques and so additional subjects were added to be able to see this effect.
Analysis to be used includes a multiple regression analysis to compare the entire cohort of control vs treatment group responses.
One-tailed, paired t test for each group to determine if the 2 groups differed in the magnitude of the decrease in time to undertake the test.
One-tailed, 2 group equal variance t-test, for the difference scores for each group.
Reaction time: timed automatically on the iPad with each user for both tests and data variations of one participant with themselves.
Significance level p<0.05

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/12/2015
Actual
19/12/2015
Date of last participant enrolment
Anticipated
31/03/2016
Actual
31/05/2016
Date of last data collection
Anticipated
Actual
31/05/2016
Sample size
Target
120
Accrual to date
Final
121
Recruitment outside Australia
Country [1] 7084 0
New Zealand
State/province [1] 7084 0
Auckland Region

Funding & Sponsors
Funding source category [1] 291810 0
Self funded/Unfunded
Name [1] 291810 0
Dr. Angela Todd
Country [1] 291810 0
Australia
Primary sponsor type
Individual
Name
Dr. Angela Todd
Address
70 Reeve St
Sale
Victoria 3850
Country
Australia
Secondary sponsor category [1] 290472 0
University
Name [1] 290472 0
Centre for Chiropractic Research (CCR), New Zealand College of chiropractic
Address [1] 290472 0
6 Harrison Road
Mt. Wellington
Auckland 1060
Country [1] 290472 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293327 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 293327 0
Ministry of Health
Ethics Department
Freyberg Building
Reception – Ground Floor
20 Aitken Street
Wellington 6011
Ethics committee country [1] 293327 0
New Zealand
Date submitted for ethics approval [1] 293327 0
24/08/2015
Approval date [1] 293327 0
12/12/2015
Ethics approval number [1] 293327 0
15/CEN/151

Summary
Brief summary
Primary purpose of this study is to investigate whether chiropractic treatment alters mental rotation test scores in healthy children aged 5-12 years.
Study Hypothesis; do chiropractic adjustments improve mental rotation ability in children aged 5-12 yrs compared to no treatment at a level greater than chance.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1097 1097 0 0
/AnzctrAttachments/369085-HDEC_RCT_Ethics_Letter - 15CEN151AM01 - Approved Amendment.pdf

Contacts
Principal investigator
Name 59398 0
Dr Angela Todd
Address 59398 0
Todd Clinics
70 Reeve Street
Sale Victoria 3850
Country 59398 0
Australia
Phone 59398 0
+61 418514546
Fax 59398 0
Email 59398 0
[email protected]
Contact person for public queries
Name 59399 0
Kelly Holt
Address 59399 0
New Zealand College Centre for Chiropractic Research
6 Harrison Rd.
Mt Wellington
Auckland 1060
Country 59399 0
New Zealand
Phone 59399 0
+6495266789
Fax 59399 0
Email 59399 0
[email protected]
Contact person for scientific queries
Name 59400 0
Angela Todd
Address 59400 0
Todd Clinics
70 Reeve St
Sale Victoria 3850
Country 59400 0
Australia
Phone 59400 0
+61 418514546
Fax 59400 0
Email 59400 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

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