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Trial registered on ANZCTR

Registration number

ACTRN12621001113842

Ethics application status

Approved

Date submitted

11/01/2021

Date registered

23/08/2021

Date last updated

14/07/2022

Date data sharing statement initially provided

23/08/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

Postural control of children with autistic spectrum disorder.

Scientific title

Posturographic assessment of postural control in children with autistic spectrum disorder.

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

children with autistic spectrum disorder

Condition category

Condition code

Mental Health

Autistic spectrum disorders

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

The main aim of the study is posturographic assessment of postural control in children with autistic spectrum disorder.

All children will undergo a three-stage postural assessment including neurological examination by a child neurologist and physiotherapy examination by a neurodevelopmental physiotherapist. Based on these examinations the children will be allocated to the experimental (children with autistic spectrum disorder) or control group (healthy children).
The third stage will be step initiation and lateral weight shifting assessment in both groups. The measurement station will consist of two (A and B) force AMTI platforms (AccuGait), charge amplifier and computer. Digital output from the platform will be recorded using AMTI's NetForce software with recording frequency of 100 Hz.
Quiet standing will be the starting position in all trials with feet comfortably aligned, arms along the trunk and eyes looking straight ahead.
Assessment of step initiation will comprise four trials:
1. Three repetitions: quiet standing on platform A for 15 seconds, then changing to Platform B (1 step) followed by quiet standing for another 15 seconds. The distance between platforms: 10cm.
2. Three repetitions: quiet standing on Platform A for 15 seconds, then changing to Platform B (1 step) followed by quiet standing for another 15 seconds. A 15-cm obstacle over the edge of the platforms; the distance between platforms: 10 cm.
3. Three repetitions – quiet standing on Platform A for 15 seconds, then changing to Platform B (1 step up) followed by quiet standing for another 15 seconds. Platform B is placed on a 17-cm base directly at the edge of Platform A.
4. Three repetitions – quiet standing on Platform B for 15 seconds, then changing to Platform A (1 step down) followed by quiet standing for another 15 seconds. Platform B is placed on a 17-cm base directly at the edge of Platform A.
Platform changing will each time start at a sound signal.

The recording of center of foot pressure (COP) displacements will be divided into three phases:
Phase 1 – quiet standing before step initiation
Phase 2 – transit
Phase 3 – quiet standing until measurement completion.
The recording will be divided into phases using an algorithm whose main elements will be foot contact with the platform and the limit of momentary COP displacement; beyond that point exit from stability or stability gain will be observed. Stability is defined as body sway where momentary COP displacement does not exceed average COP displacement plus three standard deviations. For Phase 1, average COP and SD will be calculated based on measurements made within the first 5 sec of the test. For Phase 3 – based on the last 5 sec of the test.

Assessment of lateral weight shifting from one leg to the other:

Three repetitions: each trial in the procedure will start with 10 sec of quiet standing on the platform (with feet comfortably aligned, arms along the trunk and eyes looking straight ahead on), after which an acoustic signal will be triggered to initiate the weight shift from one leg to the other without changing the base of support (no step or foot rise will be allowed). The subjects will execute the shifting weight from one leg to the other at their own pace until 15 full cycles will be completed.

The assessment will comprise two sessions: neurological and physiotherapy examinations on one day - the approximate duration of this session is 45 minutes (Stages 1 and 2); step initiation and lateral weight shifting assessment on another day - the approximate duration of this session is 25 minutes (Stage 3).

Intervention code [1]

Diagnosis / Prognosis

Comparator / control treatment

The control group participants will undergo the same three-stage procedure (neurological examination, physiotherapy examination measurements on force platforms) as children with autistic spectrum disorder.

Control group

Active

Outcomes

Primary outcome [1]

This is a composite outcome. The following will be determined:
-D1 – time from exit from stability state until the foot resting on the other platform
-D2– time from raising the foot from the first platform until gaining stability on the other platform
-double-support period (DSP) – foot contact with both platforms
-Transit time (Phase 2) – time from exit from stability state until gaining post-transit stability; the sum of D1 + DSP + D2
-Step length – distance between double-support site on each platform
This outcome will be assessed using AMTI platform and Matlab software.

Timepoint [1]

the day of examination

Secondary outcome [1]

-Center of Pressure (COP) displacement, ie., mean COP, path and velocity of COP signal
This outcome will be assessed using AMTI platform and Matlab software.

Timepoint [1]

The day of examination.

Secondary outcome [2]

The measurements of rambling (RM) trajectory :
-Range, path length, root mean square, standard deviation , velocity,
This outcome will assessed using AMTI platform and Matlab software.
This outcome will be assessed during quiet standing, step initiation and lateral weight shifting trials.

Timepoint [2]

The day of examination.

Secondary outcome [3]

The measurements of trembling (TR) trajectory
-range, path length, root mean square, standard deviation, and velocity.
This outcome will assessed using AMTI platform and Matlab software.
This outcome will be assessed during quiet standing, step initiation and lateral weight shifting trials.

Timepoint [3]

The day of examination.

Eligibility

Key inclusion criteria

The experimental group will comprise children at the age of 3-12 years with autistic spectrum disorder identified on neurological and physiotherapy examinations.
The control group will comprise children aged 3 to 12 years with no postural defects on neurological and physiotherapy examinations, no history of postural control or movement deficits.

Minimum age

3 Years

Maximum age

12 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

- genetic disorders
- progressive encephalopathy
- congenital abnormalities of the central nervous system
- infantile cerebral palsy
- no consent of the child and / or parents / guard to participate in the study.

Study design

Purpose

Screening

Duration

Cross-sectional

Selection

Case control

Timing

Prospective

Statistical methods / analysis

Determination of sample size

We assum the probability of a type I error a = 0.05, target power of 1-beta = 0.80 and a 25% minimum significant difference between the means of parameters studied. The resultant minimum sample size is 15 patients. The target sample size is 30; 2 additional participants will be recruited to account for dropouts. The study participants will be randomly assigned to 2 groups. Data analysis will be performed with Statistica, version 10.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

28/02/2022

Actual

28/02/2022

Date of last participant enrolment

Anticipated

31/05/2022

Actual

15/06/2022

Date of last data collection

Anticipated

10/06/2022

Actual

21/06/2022

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Poland

State/province [1]

Funding & Sponsors

Funding source category [1]

University

Name [1]

The Jerzy Kukuczka Academy of Physical Education

Address [1]

72a Mikolowska Street
40-065 Katowice

Country [1]

Poland

Funding source category [2]

University

Name [2]

Medical University of Silesia

Address [2]

18 Medyków Street
40-752 Katowice

Country [2]

Poland

Funding source category [3]

Other

Name [3]

Persevere – Child Development Support Center

Address [3]

Kepowa 56, 40-583, Katowice

Country [3]

Poland

Primary sponsor type

University

Name

The Jerzy Kukuczka Academy of Physical Education

Address

72a Mikolowska Street
40-065 Katowice

Country

Poland

Secondary sponsor category [1]

Other

Name [1]

Persevere – Child Development Support Center

Address [1]

Kepowa 56, 40-583, Katowice

Country [1]

Poland

Secondary sponsor category [2]

Other

Name [2]

Medical University of Silesia

Address [2]

18 Medyków Street
40-752 Katowice

Country [2]

Poland

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Komisja Bioetyczna Slaskiego Uniwersytetu Medycznego w Katowicach

Ethics committee address [1]

Poniatowskiego 15, 40-055 Katowice

Ethics committee country [1]

Poland

Date submitted for ethics approval [1]

Approval date [1]

19/05/2020

Ethics approval number [1]

PCN/0022/KB1/31/20

Summary

Brief summary

Postural control plays a fundamental role in motor behaviour. Hence it is important to identify all postural control deficits that could have a negative impact on further motor development of a child. When assessing postural control of young children, pediatricians and/or physiotherapists mainly use subjective measures including function tests. The need to find methods ensuring the measurement objectivity is therefore indisputable. 
The main aim of the study is an assessment of postural control in children with autistic spectrum disorder and in healthy children. Candidates will be qualified to participate in the study based on neurological and physiotherapy examinations. Step initiation will be performed on force platforms under various conditions, ie., with and without an obstacle, stepping up onto a platform situated at a higher level, stepping down onto a platform situated on a lower level.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Grzegorz Juras

Address

The Jerzy Kukuczka Academy of Physical Education
Institute of Sports Science
72A Mikolowska Street
40-065 Katowice

Country

Poland

Phone

+48 32 207 54 47

Fax

[email protected]

Contact person for public queries

Name

Magdalena Stania

Address

The Jerzy Kukuczka Academy of Physical Education
Institute of Sports Science
72A Mikolowska Street
40-065 Katowice

Country

Poland

Phone

+48694979640

Fax

[email protected]

Contact person for scientific queries

Name

Magdalena Stania

Address

The Jerzy Kukuczka Academy of Physical Education
Institute of Sports Science
72A Mikolowska Street
40-065 Katowice

Country

Poland

Phone

+48694979640

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
10198	Ethical approval					381184-(Uploaded-08-01-2021-00-26-51)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Modulation of center-of-pressure signal in children on the autism spectrum: A case-control study.	2023	https://dx.doi.org/10.1016/j.gaitpost.2023.04.018

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically