Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000320358
Ethics application status
Approved
Date submitted
14/06/2008
Date registered
11/07/2008
Date last updated
11/07/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Can Chiropractic care improve reading ability in children with learning delay?
Scientific title
Can Chiropractic care improve reading ability in children with learning delay?
Secondary ID [1] 582 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dyslexia 3262 0
Reading disability 3263 0
Condition category
Condition code
Alternative and Complementary Medicine 3427 3427 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Specific low force chiropractic adjustments to reduce dural tension.
1. The duration of each adjustment will be ten minutes.
2. The part of the body where the adjustment will be made is determined on each visit by a neurological protocol. Sacral, upper cervical or cranial adjustments are the most common type needed by children however occasionally the primary problem may be in an extremity.
3. The duration of the overall intervention is 16 weeks.
4. The frequency of the adjustments is once a week for 8 weeks followed by once a fornight for 8 weeks.
Intervention code [1] 3005 0
Treatment: Other
Comparator / control treatment
No treatment
Control group
Active

Outcomes
Primary outcome [1] 4323 0
Reading ability as determined by the Neale Analysis of Reading Ability.
Timepoint [1] 4323 0
At baseline and at 16 weeks which is the end of the intervention period.
Secondary outcome [1] 7289 0
Neurodevelopmental level achieved.
NEUROMATURATIONAL DELAY EXAMINATION

1.Anthropometry
2. Adrenal Function via blood pressure, pupil dilation and kidney punch test.
3. Hearing
4. Vision Snellen eye chart
5. Synkinesis
6. Dysdiadochokinesis
7. Stimulus extinction
8. Finger agnosia
9. Choreiform movements
10. Left-right discrimination (laterality)
11. Gross motor
12. Fine motor
13. Visual-perceptual-motor
14. Sequencing- Auditory and Visual
15. Goodenough Draw-A-Man
Timepoint [1] 7289 0
At baseline and at 16 weeks which is the end of the intervention period.

Eligibility
Key inclusion criteria
Child must be unable to read at expected level for his/her age and level of education.
Minimum age
7 Years
Maximum age
8 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The child is receiving any other remedial treatment (independent of their school)related to reading at the same time.

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)
When the person (in this case school teacher identifies a student as reading below expected level) s/he will be unaware whether or not the student will be included in the trial. Sealed opaque envelopes will be used.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table from a statistic book will be used to randomly allocate students to the treatment group.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/08/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3485 0
Self funded/Unfunded
Name [1] 3485 0
Esyltt Graham
Country [1] 3485 0
Australia
Primary sponsor type
Individual
Name
Esyltt Graham
Address
55 Throssell Street
Collie WA 6225
Country
Australia
Secondary sponsor category [1] 3130 0
None
Name [1] 3130 0
Address [1] 3130 0
Country [1] 3130 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5517 0
McTimoney College of Chiropractic Ethics Committee
Ethics committee address [1] 5517 0
Ethics committee country [1] 5517 0
United Kingdom
Date submitted for ethics approval [1] 5517 0
Approval date [1] 5517 0
13/06/2008
Ethics approval number [1] 5517 0
MCC-P-08-36

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

Contacts
Principal investigator
Name 28669 0
Address 28669 0
Country 28669 0
Phone 28669 0
Fax 28669 0
Email 28669 0
Contact person for public queries
Name 11826 0
Esyltt Graham
Address 11826 0
55 Throssell Street
Collie
WA 6225
Country 11826 0
Australia
Phone 11826 0
0897344800
Fax 11826 0
Email 11826 0
[email protected]
Contact person for scientific queries
Name 2754 0
Esyltt Graham
Address 2754 0
55 Throssell Street
Collie
WA 6225
Country 2754 0
Australia
Phone 2754 0
0897344800
Fax 2754 0
Email 2754 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.