Autism Spectrum DisorderNCT05650489
Autistic Features in Relation to Motor Function and Quality of Life in Children With an Autism Spectrum Disorder
An observational study of Autism Spectrum Disorder, run by Cairo University at 1 site in Egypt.
Trial summary
Although motor limitations are not currently considered a as clinical manifestation of autism spectrum disorder, should not be ignored due to their high incidence and considerable influence on life quality functional activity Read more about this study
- Who is it for?
- Ages 3 to 5 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- assessment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2020to 20 Mar 2023
- 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 3 to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Sample size calculation was performed using G power on the correlation between childhood autism rating scale and Quality of life for Spearman's rank correlation coefficient (rs) because it was the main outcome variable in the present study. a pilot study was performed on 5 patients and showed the correlation value was (r= 0.447226 and p<0.001; and a large effect size (f= 0.447226). On the basis of the results of the pilot study (a minimum sample size of 34 patients was calculated. A sample size was increased to 34 patients, but the number will be increased to 40 to show appropriate results) a minimum sample size of 34 patients was calculated. A sample size was increased to 34 patients, but it was increased to 40 to show appropriate results.
Who may be able to join
- Both sex,
- age ranges from 3 to 5 years,
- mild to moderate autistic features according to childhood autism rating scale ,
- were able to sit alone independently
Who cannot join
- Significant visual or auditory defects,
- history of cerebral palsy or psychiatric disorder (e.g attention deficit hyperactivity disorder)
Trial locations and contacts
1 site in 1 country.
About this study
Although motor limitations are not currently considered a as clinical manifestation of autism spectrum disorder, should not be ignored due to their high incidence and considerable influence on life quality functional activity
- Conditions
- Autism Spectrum Disorder
- Being tested
- assessment
- Keywords
- Autism, Motor function, quality of life, autistic features
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assessmentOther
correlation between Autistic features, motor function and quality of life
What is being measured
The primary outcome is the main question the study is designed to answer.
Autism Index
Gilliam autism rating scale:
Items on the developmental subscale address behaviors and milestones in the first 36 months of life. Items on the first three behavioral subscales are rated on a four point like scale ranging from Never Observed (0) to Frequently Observed (3). After completing it, the examiner calculated the total raw scores then converted into scaled scores and percentile ranks according to the examiner's manual. Higher scaled scores on a subscale represent severe autistic behavior. Finally, the total scaled scores were calculated to measure the autism index according to the examiner's manual. The higher the autism index, the higher the probability the individual has autism and the more severe the autistic behavior
Measured: baseline assessment
Motor Development
The Peabody Developmental Motor Scales-Second Edition:
The gross motor function domain will be assessed in the current study. The gross motor function domains contain four subtests. Reflexes, Stationary ,Locomotion and Object Manipulation .
Grading and Scoring of the PDMS-2 The therapist will ask the child to do a specific item and observes how the child is doing the task. Items are scored as 2, 1 or 0.
0 = child cannot or will not attempt an item or the attempt does not indicate that the specific skill is emerging
- child's performance shows a clear resemblance to item mastery criteria but does not fully meet the criteria or there are signs of an emerging skill
- child performs item according to the criteria specified for mastering the skill
Measured: baseline assessment
Pediatric Quality of life Inventory Scale
Pediatric Quality of life Inventory Scale:
The Arabic version will be used to assess quality of life. It contains questions about child's physical, emotional, social, and school functioning in the past 7 days. Parents/ child self-administered the quality of life after introductory instructions from the administrator. On the quality of life Generic Core Scales, for ease of interpretability, items are 22 reversed scored and linearly transformed to a 0-100 scale, so that higher scores indicate better Health-Related quality of Life. To reverse score, transform the 0-4 scale items to 0-100 as follows: 0-100, 1=75, 2= 50, 3= 25 and 4= 0. Finally, the Scale Score for each dimension and Total Scale Score were calculated
Measured: baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start15 Apr 2020
- Primary completion20 Mar 2023
- Study completion20 Mar 2023
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.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Mahmoud Abd-elmonem, Cairo University
- Investigators
- Eman s Albadry, B.S.C, Principal investigator, Cairo university, faculty of physical therapyAmr A OTHMAN, Principal investigator, Sohag UniversityMAI E ABBASS, Study chair, Cairo university, faculty of physical therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05650489
- Sponsor's protocol ID
- autism spectrum disorder
- Status last verified
- Nov 2023
- First submitted
- 6 Dec 2022
- Last updated
- 15 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autistic Features in Relation to Motor Function and Quality of Life in Children With an Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT05650489
- Acronym / sponsor ID
- autism spectrum disorder
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism, Motor function, quality of life, autistic features
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 20 Mar 2023 (actual)
- Study completion
- 20 Mar 2023 (actual)
- First posted
- 14 Dec 2022 (actual)
- 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.
Although motor limitations are not currently considered a as clinical manifestation of autism spectrum disorder, should not be ignored due to their high incidence and considerable influence on life quality functional activity
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Sample size calculation was performed using G power on the correlation between childhood autism rating scale and Quality of life for Spearman's rank correlation coefficient (rs) because it was the main outcome variable in the present study. a pilot study was performed on 5 patients and showed the correlation value was (r= 0.447226 and p<0.001; and a large effect size (f= 0.447226). On the basis of the results of the pilot study (a minimum sample size of 34 patients was calculated. A sample size was increased to 34 patients, but the number will be increased to 40 to show appropriate results) a minimum sample size of 34 patients was calculated. A sample size was increased to 34 patients, but it was increased to 40 to show appropriate results.
Key inclusion criteria (4 listed)
- Both sex,
- age ranges from 3 to 5 years,
- mild to moderate autistic features according to childhood autism rating scale ,
- were able to sit alone independently
Key exclusion criteria (2 listed)
- Significant visual or auditory defects,
- history of cerebral palsy or psychiatric disorder (e.g attention deficit hyperactivity disorder)
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 |
|---|---|---|
| assessmentcorrelation between Autistic features, motor function and quality of life | Other | – |
Primary outcome
Autism Index
Time frame: baseline assessment
Gilliam autism rating scale: Items on the developmental subscale address behaviors and milestones in the first 36 months of life. Items on the first three behavioral subscales are rated on a four point like scale ranging from Never Observed (0) to Frequently Observed (3). After completing it, the examiner calculated the total raw scores then converted into scaled scores and percentile ranks according to the examiner's manual. Higher scaled scores on a subscale represent severe autistic behavior. Finally, the total scaled scores were calculated to measure the autism index according to the examiner's manual. The higher the autism index, the higher the probability the individual has autism and the more severe the autistic behavior
Motor Development
Time frame: baseline assessment
The Peabody Developmental Motor Scales-Second Edition: The gross motor function domain will be assessed in the current study. The gross motor function domains contain four subtests. Reflexes, Stationary ,Locomotion and Object Manipulation . Grading and Scoring of the PDMS-2 The therapist will ask the child to do a specific item and observes how the child is doing the task. Items are scored as 2, 1 or 0. 0 = child cannot or will not attempt an item or the attempt does not indicate that the specific skill is emerging * child's performance shows a clear resemblance to item mastery criteria but does not fully meet the criteria or there are signs of an emerging skill * child performs item according to the criteria specified for mastering the skill
Pediatric Quality of life Inventory Scale
Time frame: baseline assessment
Pediatric Quality of life Inventory Scale: The Arabic version will be used to assess quality of life. It contains questions about child's physical, emotional, social, and school functioning in the past 7 days. Parents/ child self-administered the quality of life after introductory instructions from the administrator. On the quality of life Generic Core Scales, for ease of interpretability, items are 22 reversed scored and linearly transformed to a 0-100 scale, so that higher scores indicate better Health-Related quality of Life. To reverse score, transform the 0-4 scale items to 0-100 as follows: 0-100, 1=75, 2= 50, 3= 25 and 4= 0. Finally, the Scale Score for each dimension and Total Scale Score were calculated
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 15 Nov 2023.
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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.
Eman s Albadry, B.S.C principal investigator
Cairo university, faculty of physical therapy
Amr A OTHMAN principal investigator
Sohag University
MAI E ABBASS study chair
Cairo university, faculty of physical therapy
1 site 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 Cairo University at 1 site in Egypt.
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 4 inclusion and 2 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 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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?
Autism Index (time frame: baseline assessment). The study lists 3 primary outcomes in all. 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 15 Nov 2023.