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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] 303120 0
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 320216 0
Condition category
Condition code
Mental Health 318154 318154 0 0
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] 319418 0
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] 326143 0
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] 326143 0
the day of examination
Secondary outcome [1] 390238 0
-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] 390238 0
The day of examination.
Secondary outcome [2] 390289 0
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] 390289 0
The day of examination.
Secondary outcome [3] 399396 0
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] 399396 0
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
30
Accrual to date
Final
32
Recruitment outside Australia
Country [1] 23361 0
Poland
State/province [1] 23361 0

Funding & Sponsors
Funding source category [1] 307526 0
University
Name [1] 307526 0
The Jerzy Kukuczka Academy of Physical Education
Country [1] 307526 0
Poland
Funding source category [2] 307527 0
University
Name [2] 307527 0
Medical University of Silesia
Country [2] 307527 0
Poland
Funding source category [3] 307528 0
Other
Name [3] 307528 0
Persevere – Child Development Support Center
Country [3] 307528 0
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] 308205 0
Other
Name [1] 308205 0
Persevere – Child Development Support Center
Address [1] 308205 0
Kepowa 56, 40-583, Katowice
Country [1] 308205 0
Poland
Secondary sponsor category [2] 308206 0
Other
Name [2] 308206 0
Medical University of Silesia
Address [2] 308206 0
18 Medyków Street
40-752 Katowice
Country [2] 308206 0
Poland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307593 0
Komisja Bioetyczna Slaskiego Uniwersytetu Medycznego w Katowicach
Ethics committee address [1] 307593 0
Ethics committee country [1] 307593 0
Poland
Date submitted for ethics approval [1] 307593 0
Approval date [1] 307593 0
19/05/2020
Ethics approval number [1] 307593 0
PCN/0022/KB1/31/20

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

Contacts
Principal investigator
Name 107794 0
Prof Grzegorz Juras
Address 107794 0
The Jerzy Kukuczka Academy of Physical Education
Institute of Sports Science
72A Mikolowska Street
40-065 Katowice
Country 107794 0
Poland
Phone 107794 0
+48 32 207 54 47
Fax 107794 0
Email 107794 0
g.juras@awf.katowice.pl
Contact person for public queries
Name 107795 0
Magdalena Stania
Address 107795 0
The Jerzy Kukuczka Academy of Physical Education
Institute of Sports Science
72A Mikolowska Street
40-065 Katowice
Country 107795 0
Poland
Phone 107795 0
+48694979640
Fax 107795 0
Email 107795 0
m.stania@awf.katowice.pl
Contact person for scientific queries
Name 107796 0
Magdalena Stania
Address 107796 0
The Jerzy Kukuczka Academy of Physical Education
Institute of Sports Science
72A Mikolowska Street
40-065 Katowice
Country 107796 0
Poland
Phone 107796 0
+48694979640
Fax 107796 0
Email 107796 0
m.stania@awf.katowice.pl

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10198Ethical 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
SourceTitleYear of PublicationDOI
EmbaseModulation of center-of-pressure signal in children on the autism spectrum: A case-control study.2023https://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.