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Trial registered on ANZCTR


Registration number
ACTRN12617001068358
Ethics application status
Approved
Date submitted
26/06/2017
Date registered
21/07/2017
Date last updated
20/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Step initation in children with typical development and children with faulty posture
Scientific title
Posturographic assessment of step initation in children with typical development and children with faulty posture
Secondary ID [1] 292282 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
children with faulty posture 303799 0
Condition category
Condition code
Musculoskeletal 303168 303168 0 0
Other muscular and skeletal disorders
Neurological 303367 303367 0 0
Other neurological 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 step initiation in children aged 5-6 years. Step initiation will be studied in children with faulty posture who had been diagnosed with neurodevelopmental disorders during infancy (experimental group) and in healthy children with no history of postural control or movement deficits.
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 faulty posture) or control group (healthy children).
The third stage will be step initiation 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.

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 assessment on another day - the approximate duration of this session is  20 minutes (Stage 3).
Intervention code [1] 298454 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 faulty postures.
Control group
Active

Outcomes
Primary outcome [1] 302539 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] 302539 0
the day of examination
Secondary outcome [1] 336341 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] 336341 0
the day of examination

Eligibility
Key inclusion criteria
The experimental group will comprise children with faulty posture identified on neurological and physiotherapy examinations, who were diagnosed with neurodevelopmental disorders during infancy and were given physiotherapy in the first year of their lives.
The following postural deformities will be included in the experimental group: shoulder and scapular asymmetry, abnormal curvatures of the spine, incorrect knee alignment, foot arch deformity, foot deformity and abnormalities in the antigravity mechanism (low muscle tone, muscle tone asymmetry).
The control group will comprise nursery school children aged 5 to 6 years with no postural defects on neurological and physiotherapy examinations, no history of postural control or movement deficits and no physiotherapy interventions in the first year of their lives.
Minimum age
5 Years
Maximum age
6 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 / guardians 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 18 patients. The target sample size is 36; 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
24/07/2017
Actual
24/07/2017
Date of last participant enrolment
Anticipated
31/07/2017
Actual
4/08/2017
Date of last data collection
Anticipated
31/07/2017
Actual
4/08/2017
Sample size
Target
36
Accrual to date
Final
38
Recruitment outside Australia
Country [1] 9017 0
Poland
State/province [1] 9017 0

Funding & Sponsors
Funding source category [1] 296824 0
University
Name [1] 296824 0
The Jerzy Kukuczka Academy of Physical Education
Country [1] 296824 0
Poland
Funding source category [2] 296996 0
University
Name [2] 296996 0
Medical University of Silesia
Country [2] 296996 0
Poland
Primary sponsor type
University
Name
Medical University of Silesia
Address
18 Medyków street
40-752 Katowice
Country
Poland
Secondary sponsor category [1] 295813 0
University
Name [1] 295813 0
Jerzy Kukuczka Academy of Physical Education
Address [1] 295813 0
72A Mikolowska Street
40-001 Katowice
Country [1] 295813 0
Poland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298059 0
Ethics Committee of Medical University of Silesia
Ethics committee address [1] 298059 0
Ethics committee country [1] 298059 0
Poland
Date submitted for ethics approval [1] 298059 0
Approval date [1] 298059 0
24/05/2016
Ethics approval number [1] 298059 0
KNW/0022/KB1/54/16

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

Contacts
Principal investigator
Name 75854 0
Prof Juras Grzegorz
Address 75854 0
The Jerzy Kukuczka Academy of Physical Education
Department of Human Motor Behaviour
72A Mikolowska Street
40-001 Katowice
Country 75854 0
Poland
Phone 75854 0
+322075447
Fax 75854 0
Email 75854 0
g.juras@awf.katowice.pl
Contact person for public queries
Name 75855 0
Alina Sarat-Spek
Address 75855 0
The Independent Public Clinical Hospital no. 6 of the Medical University of Silesia in Katowice
John Paul II Upper Silesian Child Health Centre
40-752 Katowice
16 Medyków Street
Country 75855 0
Poland
Phone 75855 0
+48609792267
Fax 75855 0
Email 75855 0
alutka.sarat@gmail.com
Contact person for scientific queries
Name 75856 0
Stania Magdalena
Address 75856 0
Department of Physical Therapy, The Jerzy Kukuczka Academy of Physical Education, Mikolowska 72, 40-065 Katowice, Poland
Country 75856 0
Poland
Phone 75856 0
+48694979640
Fax 75856 0
Email 75856 0
alutka.sarat@gmail.com

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 AIStep-Initiation Deficits in Children with Faulty Posture Diagnosed with Neurodevelopmental Disorders during Infancy2017https://doi.org/10.3389/fped.2017.00239
N.B. These documents automatically identified may not have been verified by the study sponsor.