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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ANZCTR
Last refreshed on: 20 August 2018
Main ID:  ACTRN12617001068358
Date of registration: 21/07/2017
Prospective Registration: Yes
Primary sponsor: Medical University of Silesia
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
Date of first enrolment: 24/07/2017
Target sample size: 36
Recruitment status: Completed
URL:  http://www.anzctr.org.au/ACTRN12617001068358.aspx
Study type:  Observational
Study design:   
Phase: 
Countries of recruitment
Contacts
Key inclusion & exclusion criteria
Health Condition(s) or Problem(s) studied
children with faulty posture
Intervention(s)
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).
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
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