Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000598280
Ethics application status
Approved
Date submitted
14/01/2018
Date registered
18/04/2018
Date last updated
14/09/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessment of motor, psychological and social abilities of children with autism
Scientific title
Evaluation of deflections of gravity center, and other motor parameters in children with Autism Spectrum Disorder (ASD) as well as assessing the level of parental stress, the risk of burnout syndrome and other psychological assessment of people related to children with ASD.
Secondary ID [1] 293763 0
None
Universal Trial Number (UTN)
U1111-1207-6115
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder 306154 0
Parental Stress 306155 0
Depression 306156 0
Burnout syndrome 307463 0
Condition category
Condition code
Mental Health 305265 305265 0 0
Autistic spectrum disorders
Ear 305266 305266 0 0
Normal ear development and function
Mental Health 305267 305267 0 0
Depression
Physical Medicine / Rehabilitation 305268 305268 0 0
Physiotherapy
Public Health 305269 305269 0 0
Health promotion/education

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Before the tests, each child will undergo a consultation with a child psychiatrist.
Physiotherapeutic assessment of children with the autism spectrum in fields;
-Biomechanical assessment of the child's gait parameters, postural stability, sensomotoric integration. Duration time: 1 h.
-Assessment of the child's motor skills. Duration time: 1 h.
-Diagnosis of auditory attention - 'Tomatis audiometric test'. Duration time: 0,5 h.
Psychological assessment of teachers working with ASD children. Duration time: 0,5 h.
Psychological assessment of parents of children with ASD. Duration time: 0,5 h.
Assessment of public awareness of symptoms of autism. Duration time: 0,5 h.
Intervention code [1] 300015 0
Diagnosis / Prognosis
Intervention code [2] 300016 0
Early Detection / Screening
Comparator / control treatment
Control group will undergo same assessment as exposed group. Which mean;
Physiotherapeutic assessment of normal developing children.
Psychological assessment of teachers working with normal developing children.
Psychological assessment of parents of normal developing children.
Control group
Active

Outcomes
Primary outcome [1] 304429 0
Composite biomechanical assessment of the child's gait parameters. Determined by the measurement of forces and pressures under the feet and the time-space parameters of walking. It will be used pedobarographic platform Footscan (RSscan International, 2m x 0.4m x 0.02m, with 16384 sensors) with footscan 7 gait 2nd generation.
Timepoint [1] 304429 0
Participants will be assessed one time at baseline assessment (1h each patient).
Primary outcome [2] 304430 0
Psychological assessment of teachers working with ASD children.
Determined by standardised questionnaire Link Burnout Questionnaire, The scale of man at work.
The result of this test is assessed by key answers.
Timepoint [2] 304430 0
Participants will be assessed one time at baseline assessment (0,5h each patient).
Primary outcome [3] 304431 0
Psychological assessment of parents of children with ASD.
Determined by standardised questionnaire Flexibility and Cohesion Evaluation Scales, The Oxford Happiness Questionnaire, Beck's Depression Inventory.
The result of this test is assessed by key answers.
Timepoint [3] 304431 0
Participants will be assessed one time at baseline assessment (0,5h each patient).
Secondary outcome [1] 341921 0
Primary outcome: Diagnosis of auditory attention - 'Tomatis audiometric test'
Timepoint [1] 341921 0
Participants will be assessed one time at baseline assessment (0,5h each patient).
Secondary outcome [2] 343283 0
Primary outcome: Assessment of public awareness of symptoms of autism.
Determined by standardised questionnaire 'KCAHW' (Knowledge about childhood autism among health workers).
The result of this test is assessed by key answers.
Timepoint [2] 343283 0
Participants will be assessed one time at baseline assessment (0,5h each patient).
Secondary outcome [3] 344187 0
Primary outcome: Sensomotoric integration- determined by The Southern California Sensory Integration Tests and Sensory Profile test.
Timepoint [3] 344187 0
Primary timepoint: Participants will be assessed one time at baseline assessment (1h each patient).

Eligibility
Key inclusion criteria
For children in study group;
-autism diagnosis
-pre-school age (from 2 years to 10 years).

Assessment of parents in study group - the inclusion criteria will be the possession of a child from the autism spectrum. In the control group - having a healthy child.

In the assessment of teachers in the study group - teacher's who work with autistic children and in the control colony- teacher's work with healthy children.

In the assessment of autism knowledge - all ex. medical, psychological students.
Minimum age
2 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
-age over pre- school childrens,
-disability of the movement which may prevent participation in biomechanical tests,
-deafness confirmed by a medical diagnosis.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Research will be covered;
- 30 pre-school children diagnosed with ASD
- 30 healthy neurotypical children
- 30 parents of children with ASD
- 30 parents of neurotypical children
- 30 teachers working with children with ASD
- 30 teachers working with healthy children,
- 200 students (medical, pedagogical, psychological and other studies)
- 200 representatives of medical professions.
In total- sample size- 580
-Body composition analysis. All patients will be checking one time with 'TANITA DC-360 S' system.
-Biomechanical analysis with RSscan International 2m x 0.4m x 0.02m, with 16384 sensors and footscan 7 gait 2nd generation system.The measurement will be performed without shoes using the midgait method.
-Postural stability.The balancing test will be carried out using the Footscan platform with the Footscan Balance 7.7 2nd Generation System with a sampling rate of 100 Hz.
-Assessment of sensory disorders. Sensory Child Profile and South California Sensory Integration Tests.
-A diagnosis of auditory attention will be made using the Tomatis method.
-Teachers will be check by; ‘The scale of a man at work’ and ‘LBQ Burnout Questionnaire’
-Parents with children with ASD are will be check by; Family Assessment Scale.
-Medical Professions and students will be check with ‘KCAHW- Knowledge about Childhood Autism among Health Workers'

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
7/12/2017
Date of last participant enrolment
Anticipated
30/09/2018
Actual
Date of last data collection
Anticipated
30/09/2018
Actual
Sample size
Target
580
Accrual to date
100
Final
Recruitment outside Australia
Country [1] 9487 0
Poland
State/province [1] 9487 0

Funding & Sponsors
Funding source category [1] 298379 0
University
Name [1] 298379 0
Poznan Univeristy of Medical Sciences
Country [1] 298379 0
Poland
Primary sponsor type
University
Name
Poznan Univeristy of Medical Sciences
Address
ul. Fredry 10
61-701 Poznan
POLAND
Country
Poland
Secondary sponsor category [1] 297514 0
None
Name [1] 297514 0
Address [1] 297514 0
Country [1] 297514 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299371 0
Bioethics Committee of the Poznan Univeristy of Medical Sciences
Ethics committee address [1] 299371 0
Ethics committee country [1] 299371 0
Poland
Date submitted for ethics approval [1] 299371 0
Approval date [1] 299371 0
07/12/2017
Ethics approval number [1] 299371 0
1223/17

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

Contacts
Principal investigator
Name 80210 0
Mr Piotr Poniewierski
Address 80210 0
Klinika Reumatologii i Rehabilitacji
ul. 28 Czerwca 1956 r. 135/147
61-545 Poznan
Country 80210 0
Poland
Phone 80210 0
+48 508729490
Fax 80210 0
Email 80210 0
[email protected]
Contact person for public queries
Name 80211 0
Piotr Poniewierski
Address 80211 0
Klinika Reumatologii i Rehabilitacji
ul. 28 Czerwca 1956 r. 135/147
61-545 Poznan
Country 80211 0
Poland
Phone 80211 0
+48 508729490
Fax 80211 0
Email 80211 0
[email protected]
Contact person for scientific queries
Name 80212 0
Piotr Poniewierski
Address 80212 0
Klinika Reumatologii i Rehabilitacji
ul. 28 Czerwca 1956 r. 135/147
61-545 Poznan
Country 80212 0
Poland
Phone 80212 0
+48 508729490
Fax 80212 0
Email 80212 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
SourceTitleYear of PublicationDOI
Dimensions AIThe estimation of the functioning of families with ASD children2019https://doi.org/10.3934/publichealth.2019.4.587
N.B. These documents automatically identified may not have been verified by the study sponsor.