Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000106639
Ethics application status
Approved
Date submitted
1/10/2013
Date registered
29/01/2014
Date last updated
29/01/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Developmental coordination disorder – do personnel and environment impact on intervention outcomes for this condition?
Scientific title
Does the personnel delivering intervention and the environment of intervention impact on motor and psychosocial outcomes for children with Developmental Coordination Disorder (DCD)?
Secondary ID [1] 283332 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Developmental Coordination Disorder 290226 0
Condition category
Condition code
Neurological 290620 290620 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants received a group based task specific motor intervention in which they attended a one hour session once a week for 13 weeks. The one hour seession included gross motor and fine motor activities which were developmentally appropriate for 5- 8 year olds. The basis of task specific intervention is practising the task itself under different conditions rather than focussing on impairments which contribute to difficulties with task. Each group had a maximum of 6 participants and had a staff to participant ratio of 1:3. There were three intervention modes which were compared. One mode was run by a physiotherapist in a health clinic setting, a second mode was run by a physiotherapist in a school setting and a third mode was run by a school assistant in a school setting.
Intervention code [1] 288056 0
Treatment: Other
Comparator / control treatment
Evidence based intervention delivered by physiotherapist in clinic setting which accounts for the mode of intervention provided by a physiotherapist in a health clinic setting. This group of participants received the group based task specific intervention once a week for an hour over 13 weeks in groups of 4-6 with a staff to participant ratio of 1:3.
Control group
Active

Outcomes
Primary outcome [1] 290631 0
Motor Skill Competence assessed using Movement Assessment Battery for Children (MABC) and Test of Gross Motor Development (TGMD-2)
Timepoint [1] 290631 0
Immediately post intervention
Secondary outcome [1] 304935 0
Perceived self competence and social acceptance assessed using the Pictorial Scale of Percevied Self Competence and Social Acceptance.
Timepoint [1] 304935 0
Immediately post- intervention

Eligibility
Key inclusion criteria
Children aged 5- 8 years meeting DSM-IV-TR criteria for Developmental Coordination Disorder
Minimum age
5 Years
Maximum age
9 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Intellectual Disability and Autism

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)
Children screened in select SA public schools for DCD using standardised questionnaire DCD-Q. If consented children deemed at risk of DCD complete further testing using Movement Assessment Battery for Children (MABC) to confirm motor impairment and parents complete questionniare to screen for exclusion criteria. Children in each school identified with DCD offered intervention. Type of intervention determined by cluster randomisation of schools to particular mode of intervention. Assessor was blind to type of intervention each school was allocated.Randomisation of schools was generated from a computer random numbers table and allocated by a third party independent of the study who was "off site".
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Schools randomised computer generated to either control or 2 other intervention modes
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Two settings and two types of personnel were compared for intervention delivery. Health centre based therapy by physiotherapist known to be effective was compared to school based intervention by physiotherapist to compare environment. Personnel were compared by adding a third group providing intervention in schools run by schools assistants.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Mixed model analysis of motor and psychosocial outcomes, significance level p<0.05
Power Calculation : Power calculations determined 78 participants with 26 in each mode of delivery required for 80% power with an alpha level of 0.05 based on a 6.5 point change in MABC score. While 78 were required 93 were recruited providing a larger sample.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/07/2006
Actual
14/07/2006
Date of last participant enrolment
Anticipated
30/01/2007
Actual
5/03/2007
Date of last data collection
Anticipated
Actual
Sample size
Target
93
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 7394 0
5046 - Warradale
Recruitment postcode(s) [2] 7395 0
5045 - Glenelg
Recruitment postcode(s) [3] 7396 0
5048 - Brighton
Recruitment postcode(s) [4] 7397 0
5159 - Happy Valley
Recruitment postcode(s) [5] 7398 0
5163 - Hackham
Recruitment postcode(s) [6] 7399 0
5166 - O'sullivan Beach
Recruitment postcode(s) [7] 7400 0
5168 - Noarlunga Centre
Recruitment postcode(s) [8] 7401 0
5038 - Plympton
Recruitment postcode(s) [9] 7402 0
5035 - Black Forest
Recruitment postcode(s) [10] 7403 0
5039 - Edwardstown
Recruitment postcode(s) [11] 7404 0
5043 - Ascot Park

Funding & Sponsors
Funding source category [1] 288066 0
University
Name [1] 288066 0
University of South Australia
Country [1] 288066 0
Australia
Funding source category [2] 288067 0
Charities/Societies/Foundations
Name [2] 288067 0
Volunteer Service for Flinders Medical Centre Inc
Country [2] 288067 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
GPO Box 2471
Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 286788 0
Government body
Name [1] 286788 0
Department of Education and Child Development
Address [1] 286788 0
GPO Box 1152
ADELAIDE SA 5001
Country [1] 286788 0
Australia
Other collaborator category [1] 277642 0
Hospital
Name [1] 277642 0
Southern Adelaide Health Service
Address [1] 277642 0
Flinders Drive
Bedford Park SA 5062
Country [1] 277642 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289991 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 289991 0
Ethics committee country [1] 289991 0
Australia
Date submitted for ethics approval [1] 289991 0
Approval date [1] 289991 0
07/07/2006
Ethics approval number [1] 289991 0
P137/06
Ethics committee name [2] 289992 0
Flinders Medical Centre Research Ethics Committee
Ethics committee address [2] 289992 0
Ethics committee country [2] 289992 0
Australia
Date submitted for ethics approval [2] 289992 0
Approval date [2] 289992 0
05/07/2006
Ethics approval number [2] 289992 0
FWA A00001785
Ethics committee name [3] 289993 0
Department of Education and Children's Services Ethics Committee
Ethics committee address [3] 289993 0
Ethics committee country [3] 289993 0
Australia
Date submitted for ethics approval [3] 289993 0
Approval date [3] 289993 0
11/07/2006
Ethics approval number [3] 289993 0
CS/06/0110-2.1

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

Contacts
Principal investigator
Name 43394 0
Dr Emily Ward
Address 43394 0
University of South Australia
School of Health Sciences
PO Box 2471
Adelaide 5001
Country 43394 0
Australia
Phone 43394 0
+61 8 83021839
Fax 43394 0
Email 43394 0
[email protected]
Contact person for public queries
Name 43395 0
Emily Ward
Address 43395 0
University of South Australia
School of Health Sciences
PO Box 2471
Adelaide 5001
Country 43395 0
Australia
Phone 43395 0
+61 8 83021839
Fax 43395 0
Email 43395 0
[email protected]
Contact person for scientific queries
Name 43396 0
Emily Ward
Address 43396 0
University of South Australia
School of Health Sciences
PO Box 2471
Adelaide 5001
Country 43396 0
Australia
Phone 43396 0
+61 8 83021839
Fax 43396 0
Email 43396 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.