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.
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
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).
- Conditions
- Autism Spectrum Disorder
- 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 group | Role | What they receive |
|---|---|---|
| children with Autism Spectrum Disorder | no intervention required Receives: Other: no intervention required | |
| heathy children | no intervention required Receives: Other: no intervention required |
What is being measured
The primary outcome is the main question the study is designed to answer.
postural stability measures
Measured: baseline
Secondary outcomes (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.
- First posted23 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Itshak Melzer, Soroka University Medical Center
- Investigators
- Itshak Melzer, Phd, Principal investigator, Ben-Gurion University of the Negev
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postural Control During Walking and Standing Among Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT02584972
- Acronym / sponsor ID
- PCASD / Sor 274-13 CTIL
- Conditions
- Autism Spectrum Disorder
- Keywords
- Postural control, Gait, Children, Autism Spectrum Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 23 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| children with Autism Spectrum Disorder | – | Other: no intervention requiredno intervention required |
| heathy children | – | Other: no intervention requiredno intervention required |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children with autism spectrum disorder
Key inclusion criteria (3 listed)
- children with autism spectrum disorder
- 6-12 years old
- able to walk independently
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no intervention requiredno intervention required | Other | children with Autism Spectrum Disorder, heathy children |
Primary outcome
postural stability measures
Time frame: baseline
1 secondary outcome
6 meter Narrow Path Walking Test
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Itshak Melzer, Phd principal investigator
Ben-Gurion University of the Negev
2 sites in 1 country: see every site and its status.
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.