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Autism Spectrum DisorderPCASDNCT02584972

Postural Control During Walking and Standing Among Children With Autism Spectrum Disorder

An observational study of Autism Spectrum Disorder, run by Soroka University Medical Center at 2 sites in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Lately, many researchers have found that Children with autism spectrum disorder (ASD) are most likely to have gross motor deficiencies such as lack of coordination in gait and balance. Read more about this study

Who is it for?
Ages 6 to 12 years
Conditions the study is for
Autism Spectrum Disorder
How many people
40 participants
Where
2 sitesIsrael
Study dates
Nov 2015to Oct 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: children with autism spectrum disorder

Who may be able to join

  • children with autism spectrum disorder
  • 6-12 years old
  • able to walk independently

Who cannot join

  • ASD children who were diagnosed with neurological, orthopedic, or psychiatric diagnoses according to DSM-IV criteria that can affect motor control and postural stability;
  • cerebral palsy; - neuropathic diseases;
  • limb fracture;
  • head trauma during the previous year;
  • who had an IQ score below the normal range (<70), as assessed by the Wechsler Intelligence Scale for Children - Revised (Wisc-R) administered by a child psychologist.

Trial locations and contacts

2 sites in 1 country.

Israel2 sites
  • Ben-guion University of the Negev,

    Beersheba, 84105

  • Soroka University Medical Center

    Beersheba

Other trials in Israel

About this study

Lately, many researchers have found that Children with autism spectrum disorder (ASD) are most likely to have gross motor deficiencies such as lack of coordination in gait and balance. Much has been researched on etiology and motor learning, but only very few researches have examined and analyzed quantitatively gait and balance in ASD. The aim of this research is to analyze quantitatively balance, gait and balance during perturbation in children with ASD and to compare with typically developed children (TD). A group of 20 children diagnosed with ASD and a control group of 20 TD children will be recruited and tested in the laboratory with well-established measures of gait and balance function. They will be instructed to stand as still as possible on a force plate with different task conditions : (1) standing with the eyes open (EO) - standing upright viewing an "X" displayed on a screen 3 meters in front of them; (2) eyes closed (EC) - same as (1) with the eyes closed and covered by blindfolds (i.e. no visual information). (3) Same as 1 standing on foam (i.e., conflicting proprioceptive information). Gait will be measured using the narrow base walk test, modified for clinical use. Participants will be asked to walk within a narrow path 6 meters long . The statistical analysis will include Independent T-tests to compare the ASD and controls with respect to different characteristics. General Linear Model (GLM) will be used by applying a separate model where the dependent variables will be the average values of the postural stability or gait stability parameters (continuous) and the independent variables were categorical by the group and task condition.

Read the detailed description

Study protocol The study group will be consisted of 30 ASD children (6-12 years old) who were diagnosed with ASD recruited in the Pediatric Neurology clinic at Soroka Medical Center, Beer-Sheva, Israel, and ASD centers. A convenience sample of 30 age-gender matched healthy control children (6-12 years old) will be recruited using ads and flayer in Beer-Sheva and area. Children's parents will sign the informed consent, in accordance with procedures approved by the Helsinki Ethics Committee in Soroka Medical Center. As part of the initial assessment all children including the control group subjects will undergo a complete neuro-developmental and motor screening evaluation by an experienced pediatric neurologist using the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) diagnostic criteria Children with autism have to meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria. ASD participants will have to communicate enough in order to cooperate and understand orders. Exclusion criteria are: ASD children who were diagnosed with neurological, orthopedic, or psychiatric diagnoses according to DSM-IV criteria that can affect motor control and postural stability; cerebral palsy; neuropathic diseases; limb fracture; head trauma during the previous year; use of any medication other than MPH during the study period; and who had an IQ score below the normal range (<70), as assessed by the Wechsler Intelligence Scale for Children - Revised (Wisc-R) administered by a child psychologist.

Recruitment procedure ASD participants will be recruited in the children neurology department at Soroka Medical center. Control group subjects will be recruited from the community using personal contacts using ads and flayer. The PI of this project (Prof. Zamir) will not be involved in the recruitment procedure of the children's under his clinical practice.

Outcome Assessments: Postural stability Protocol The assessment procedure will be made in the ediatric Neurology clinic at Soroka Medical Center, Beer-Sheva, the parents will sign of the informed consent than the participant will be instructed to stand upright as still as possible on the force platform with the feet positioned as close as possible (heels and toes touching). A total of five 30-second quiet-standing trials will be obtained from each participant instructed to stand as still as they possibly can in two task conditions. Two minute rest break will be provided between two task conditions and thirty seconds rest breaks between the trials. The two task conditions are: (1) standing with the eyes open (EO) - standing upright viewing an "X" displayed on a screen 3 meters in front of them; (2) eyes closed (EC) - same as (1) with the eyes closed and covered by blindfolds (i.e. no visual information). (3) Same as 1 standing on foam (i.e., conflicting proprioceptive information). Balance measurements will be collected with a Kistler 9287 single force platform (Kistler Instrument Corp., Winterthur, Switzerland) that measures the time-varying displacement of the Center of pressure (CoP). The force platform data will be sampled at a frequency of 100 Hz and stored on a hard disk for later processing. Four well-established parameters of postural stability will be extracted using automatic code written in Matlab (Math Works Inc., Cambridge, MA, USA): 1) Mediolateral CoP range (mm) (ML-sway Range); 2) Anterioposterior CoP range (mm) (AP-sway Range); 3) Mean velocity of CoP sway (mm/sec); 4) Sway area (mm2) - the elliptical area of the CoP points. Lower postural stability scores indicate higher levels of postural control. Also four parameters of SDA were extracted using automatic code written in Matlab: 1) short-term diffusion coefficients in mm2s-1 (Drs); 2) long-term diffusion coefficients in mm2s-1 (Drl); 3) the Critical Time in sec (Ctr); and 4) Critical Displacement in cm (Cdr). These parameters will be computed for each subject's trials, and then averaged for each set of 5 trials to obtain an average value for each parameter and for each subject, in each experimental condition.

Gait stability protocol After a 10-minute break, gait will be measured using the narrow base walk test, modified for clinical use. Participants will be asked to walk within a narrow path (6 meters long) first without and then with a concurrent cognitive task (ST- and DT), always in the same order. The test incorporates measurement of lateral instability during gait. The width of the narrow path will be normalized to 50% of the distance between the participant's anterior superior iliac spines + the width of the subject's shoe. This produces a similar challenge for individuals with different body morphologies. The narrow path will be outlined by two narrow six meter black mattresses on the walking surface; the participants will be instructed to walk within the path without stepping on the black mattresses. All trials will be videotaped using a video-camera that was placed 2 meters in front of the walking path and 1.5 meters high to detect trial time and step errors during the test. Step error is defined as every step where the subject's shoes step outside the narrow path, touching the black mattresses outlining the sides of the narrow base walkway. test-re-test agreement of NBWT found to be high for all variables; ICC(1,2) 0.77-0.92 in ST and 0.78-0.92 in DT (unpublished data).

Being tested
no intervention required
Keywords
Postural control, Gait, Children, Autism Spectrum Disorder
Medical subject headings
Autism Spectrum Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • no intervention requiredOther

    no intervention required

Study groups in NCT02584972
Study groupRoleWhat they receive
children with Autism Spectrum Disorderno intervention required
Receives: Other: no intervention required
heathy childrenno intervention required
Receives: Other: no intervention required

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. postural stability measures

    Measured: baseline

Secondary outcomes (1)
  1. 6 meter Narrow Path Walking Test

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2015 (estimated)
  2. Study startNov 2015
  3. Primary completionOct 2017
  4. Study completionOct 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02584972
Sponsor's protocol ID
Sor 274-13 CTIL
Acronym
PCASD
Status last verified
Jul 2021
First submitted
18 Oct 2015
Last updated
30 Jul 2021
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Autism Spectrum Disorder, run by Soroka University Medical Center at 2 sites in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

postural stability measures (time frame: baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2021.

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