Autism Spectrum DisorderNCT04696133
Sensory Integration Versus Fine Motor Intervention in Children With Autism
A study testing fine motor skills and sensory integration in people with Autism Spectrum Disorder, run by Cairo University at 1 site in Egypt.
Trial summary
Clinically, infants with Autism spectrum often display gross motor delays in supine, prone, and sitting skills in their first year of life. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- fine motor skills and sensory integration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2020to 15 Aug 2023
- Phase
- Interventional
- 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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age ranges from 8 to 12 years.
- Mild to moderate autistic features
Who cannot join
- Significant visual or auditory defects.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Therapeutic Outcomes of Sensory Integration Versus Fine Motor Intervention on Autistic Features and Fine Motor Skills in Children With Autism: A Randomized Controlled Trial
Clinically, infants with Autism spectrum often display gross motor delays in supine, prone, and sitting skills in their first year of life.
- Conditions
- Autism Spectrum Disorder
- Being tested
- fine motor skills, sensory integration
- Keywords
- Autism Spectrum Disorder, Quality of life, sensory integration, fine motor skills
- 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.
fine motor skillsOther
stretching and strengthening exercises in addition to exercises to enhance fine motor skills
sensory integrationOther
- Tactile stimulation
- Proprioceptive stimulation
| Study group | Role | What they receive |
|---|---|---|
| conventional training | Experimental | children received fine motor exercises Receives: Other: fine motor skills |
| sensory integration training | Experimental | Children received designed sensory integration program Receives: Other: sensory integration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gilliam autism rating scale
higher the autism index, indicate the probability the individual has autism
Measured: 3 months
Secondary outcomes (1)
Bruininks-Oseretsky Test Of Motor Proficiency
Fine manual control domain will be assessed in the current study. Gender specific norms were used for scoring as the scale's authors report these as being more accurate than combined gender norms
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start15 Mar 2020
- Primary completion15 May 2022
- Study completion15 Aug 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- 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
- Emam H El-Negamy, professor, Study chair, Cairo Universitykamilia saad, Study director, Cairo Universitydalia galal, Principal investigator, Cairo university, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04696133
- Sponsor's protocol ID
- Autism spectrum
- Status last verified
- Mar 2024
- First submitted
- 3 Jan 2021
- Last updated
- 8 Mar 2024
- 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 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Outcomes of Sensory Integration Versus Fine Motor Intervention on Autistic Features and Fine Motor Skills in Children With Autism: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04696133
- Acronym / sponsor ID
- Autism spectrum
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Spectrum Disorder, Quality of life, sensory integration, fine motor skills
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Mar 2020 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 6 Jan 2021 (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.
Clinically, infants with Autism spectrum often display gross motor delays in supine, prone, and sitting skills in their first year of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional training | Experimental | Other: fine motor skillschildren received fine motor exercises |
| sensory integration training | Experimental | Other: sensory integrationChildren received designed sensory integration program |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age ranges from 8 to 12 years.
- Mild to moderate autistic features
Key exclusion criteria (1 listed)
- Significant visual or auditory defects.
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 |
|---|---|---|
| fine motor skillsstretching and strengthening exercises in addition to exercises to enhance fine motor skills | Other | conventional training |
| sensory integration* Tactile stimulation * Proprioceptive stimulation | Other | sensory integration training |
Primary outcome
Gilliam autism rating scale
Time frame: 3 months
higher the autism index, indicate the probability the individual has autism
1 secondary outcome
Bruininks-Oseretsky Test Of Motor Proficiency
Time frame: 3 months
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 8 Mar 2024.
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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.
Emam H El-Negamy, professor study chair
Cairo University
kamilia saad study director
Cairo University
dalia galal principal investigator
Cairo university, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fine motor skills and sensory integration in people with 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 2 inclusion and 1 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 8 Mar 2024. 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?
Gilliam autism rating scale (time frame: 3 months). 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 8 Mar 2024.