Down SyndromeNCT07785011
Effect of Sensory Integration on Gross and Balance on Children With Down Syndrome
A study testing BALANCE AND SENSORY INTEGRATION in people with Down Syndrome, run by Raheel Sanad at 1 site in Egypt.
Trial summary
To investigate the effect of sensory integration on gross motor function in children with Down syndrome. To investigate the effect of sensory integration on balance in children with Down syndrome. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Down Syndrome
- What is being tested?
- BALANCE AND SENSORY INTEGRATION
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2025to 15 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Child
Who may be able to join
- All children diagnosed as Down syndrome, according to genetic lab reports.
- Their age ranges from 3to 5 years.
- Both genders will be included.
- They are able to stand alone.
- They are able to follow instructions. Their IQ ranges from 65 to 80, according to Stanford Binet Intelligence Scale).
- They had been referred by sensory integration problems (low registration and seeking behavior).
Who cannot join
- Patients will be excluded from the study if they have any of the following:
- Persistent heart disease.
- Severe cognitive impairments.
- Recent surgical interference in the lower limbs.
- Obese children (BMI > 95).
- Patients with hip subluxation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Abo EL resh hospital
Cairo, 02
raheel sanad, master, 01018263304, raheelsanad90@gmail.com
About this study
Official title: Effect of Sensory Integration on Gross Motor Function and Balance in Children With Down Syndrome
To investigate the effect of sensory integration on gross motor function in children with Down syndrome.
To investigate the effect of sensory integration on balance in children with Down syndrome.
Read the detailed description
This study will be delimited to:
- sixety children with Down syndrome, ranging in age from3 to 5 years.
- Children will be divided randomly into two groups of equal number: Control group (Group A) will receive designed physical therapy program and study group (Group B) will receive the same designed physical therapy exercises in addition to sensory integration program.
- All children will be assessed by Gross Motor Function Measure Scale (GMFM-88) and HUMAC balance system before and after the intervention.
- Conditions
- Down Syndrome
- Being tested
- BALANCE AND SENSORY INTEGRATION
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BALANCE AND SENSORY INTEGRATIONBehavioural
Participants in the controlled group will receive a designed physical therapy program for 60 minutes,three times per week ,for 3 months.
Participants in the study group will receive a designed physical therapy program for 30 minutes followed by a sensory integration program for 30 minutes,three times per week for 3 months. the designed physical therapy will include balance and strengthening exercises on the other hand sensory integration program will include different textured surfaces, vistebular stimulation
| Study group | Role | What they receive |
|---|---|---|
| CONTROLLED GROUP | Experimental | Children in this group will receive designed physical therapy program for 60 minutes, 3 times per week for 3 months Receives: Behavioral: BALANCE AND SENSORY INTEGRATION |
| STUDY GROUP | Experimental | Children in this group will receive the same designed physical therapy exercises for 30 minutes and sensory program for other 30 minutes three times per week for 3 months. Receives: Behavioral: BALANCE AND SENSORY INTEGRATION |
What is being measured
The primary outcome is the main question the study is designed to answer.
balance measured by Stability Score of the Clinical Test of Sensory Interaction on Balance(CTSIB) using HUMAC Balance system
balance will be assessed by the results of stability score of the Clinical Test of Sensory Interaction on Balance (CTSIB ) using HUMAC Balance system the stability score will be recorded at four conditions 1_child stand on stable surface with open eye 2_child stand on stable surface with closed eye 3_ child stand on foam surface with open eye 4_ child stand on foam surface with closed eye
Measured: 3 monthes
Secondary outcomes (1)
gross motor function will be assessed by Gross motor function measurement-88 scale
The motor function skills of all children in the study will be measured by Gross Motor Function Measurement-88 scale which is a criterion based observational measure. Standing and walking dimensions only will be selected to be tested
Measured: 3 monthes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start15 Sep 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participations who meet the eligibility criteria will be allocated by simple randomization via sealed opaque envelopes into two matched groups by an independent person: • Group A (control group): Children in this group will receive designed physical therapy program for 60 minutes, 3 times per week for 3 months Group B (study group): Children in this group will receive the same designed physical therapy exercises for 30 minutes and sensory program for other 30 minutes three times per week for 3 months.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Raheel Sanad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Raheel Sanad, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07785011
- Sponsor's protocol ID
- Raheel _SI_2025
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participations who meet the eligibility criteria will be allocated by simple randomization via sealed opaque envelopes into two matched groups by an independent person: • Group A (control group): Children in this group will receive designed physical therapy program for 60 minutes, 3 times per week for 3 months Group B (study group): Children in this group will receive the same designed physical therapy exercises for 30 minutes and sensory program for other 30 minutes three times per week for 3 months
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sensory Integration on Gross Motor Function and Balance in Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT07785011
- Acronym / sponsor ID
- Raheel _SI_2025
- Conditions
- Down Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Raheel SanadUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 25 Aug 2026 (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.
To investigate the effect of sensory integration on gross motor function in children with Down syndrome.
To investigate the effect of sensory integration on balance in children with Down syndrome.
Detailed description
This study will be delimited to:
- sixety children with Down syndrome, ranging in age from3 to 5 years.
- Children will be divided randomly into two groups of equal number: Control group (Group A) will receive designed physical therapy program and study group (Group B) will receive the same designed physical therapy exercises in addition to sensory integration program.
- All children will be assessed by Gross Motor Function Measure Scale (GMFM-88) and HUMAC balance system before and after the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participations who meet the eligibility criteria will be allocated by simple randomization via sealed opaque envelopes into two matched groups by an independent person: • Group A (control group): Children in this group will receive designed physical therapy program for 60 minutes, 3 times per week for 3 months Group B (study group): Children in this group will receive the same designed physical therapy exercises for 30 minutes and sensory program for other 30 minutes three times per week for 3 months.
| Arm | Type | Receives |
|---|---|---|
| CONTROLLED GROUP | Experimental | Behavioral: BALANCE AND SENSORY INTEGRATIONChildren in this group will receive designed physical therapy program for 60 minutes, 3 times per week for 3 months |
| STUDY GROUP | Experimental | Behavioral: BALANCE AND SENSORY INTEGRATIONChildren in this group will receive the same designed physical therapy exercises for 30 minutes and sensory program for other 30 minutes three times per week for 3 months. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- All children diagnosed as Down syndrome, according to genetic lab reports.
- Their age ranges from 3to 5 years.
- Both genders will be included.
- They are able to stand alone.
- They are able to follow instructions. Their IQ ranges from 65 to 80, according to Stanford Binet Intelligence Scale).
Key exclusion criteria (6 listed)
- Persistent heart disease.
- Severe cognitive impairments.
- Recent surgical interference in the lower limbs.
- Obese children (BMI > 95).
- Patients with hip subluxation.
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 |
|---|---|---|
| BALANCE AND SENSORY INTEGRATIONParticipants in the controlled group will receive a designed physical therapy program for 60 minutes,three times per week ,for 3 months. Participants in the study group will receive a designed physical therapy program for 30 minutes followed by a sensory integration program for 30 minutes,three times per week for 3 months. the designed physical therapy will include balance and strengthening exercises on the other hand sensory integration program will include different textured surfaces, vistebular stimulation | Behavioural | CONTROLLED GROUP, STUDY GROUP |
Primary outcome
balance measured by Stability Score of the Clinical Test of Sensory Interaction on Balance(CTSIB) using HUMAC Balance system
Time frame: 3 monthes
balance will be assessed by the results of stability score of the Clinical Test of Sensory Interaction on Balance (CTSIB ) using HUMAC Balance system the stability score will be recorded at four conditions 1_child stand on stable surface with open eye 2_child stand on stable surface with closed eye 3_ child stand on foam surface with open eye 4_ child stand on foam surface with closed eye
1 secondary outcome
gross motor function will be assessed by Gross motor function measurement-88 scale
Time frame: 3 monthes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: Yes. Participations who meet the eligibility criteria will be allocated by simple randomization via sealed opaque envelopes into two matched groups by an independent person: • Group A (control group): Children in this group will receive designed physical therapy program for 60 minutes, 3 times per week for 3 months Group B (study group): Children in this group will receive the same designed physical therapy exercises for 30 minutes and sensory program for other 30 minutes three times per week for 3 months
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BALANCE AND SENSORY INTEGRATION in people with Down Syndrome, run by Raheel Sanad 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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 25 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact raheel sanad, doctoral (01018263304, raheelsanad90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
balance measured by Stability Score of the Clinical Test of Sensory Interaction on Balance(CTSIB) using HUMAC Balance system (time frame: 3 monthes). 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 25 Aug 2026.