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RecruitingNCT07785011Updated Aug 25, 2026

Effect of Sensory Integration on Gross and Balance on Children With Down Syndrome

An interventional study of BALANCE AND SENSORY INTEGRATION in Down Syndrome, sponsored by Raheel Sanad. Recruiting at 1 site in Egypt. Open to participants aged 3 Years to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-25.

Sponsored by Raheel Sanad · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Sep 2025, registered Aug 2026).
  • Started Sep 2025; still recruiting 1 year 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
3 Years to 5 Years
Sex
All
01

Study 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 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.
02

Conditions studied

  • Down Syndrome

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03

In context

Down Syndrome

438 studies on the registry are indexed under Down Syndrome; 99 are open to participants now.

This study's planned enrollment of 40 is close to the median of 37 across 286 interventional studies indexed under Down Syndrome.

Browse Down Syndrome studies →

Lead sponsor

This is the only study on the registry with Raheel Sanad as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 5 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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).

Exclusion criteria

Exclusion Criteria:

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 ( > 95).
  • Patients with hip subluxation.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    CONTROLLED GROUP

    Children in this group will receive designed physical therapy program for 60 minutes, 3 times per week for 3 months

    Behavioral: BALANCE AND SENSORY INTEGRATION

  • Experimental
    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.

    Behavioral: BALANCE AND SENSORY INTEGRATION

Interventions

  • BehavioralBALANCE AND SENSORY INTEGRATION

    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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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

    Time frame: 3 monthes

07

Study locations

1 of 1 sites recruiting
  • Abo EL resh hospital
    Cairo, 02, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: 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

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

Time frame: 3 monthes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07785011
Lead sponsor
Raheel Sanad
Responsible party
Raheel Sanad (Physiotherapist, Cairo University) — Sponsor-investigator
First posted
Aug 25, 2026
Start date
Sep 15, 2025
Primary completion
Oct 1, 2026 (estimated)
Completion
Oct 15, 2026 (estimated)
Last update
Aug 25, 2026

Study contacts

raheel sanad, doctoral
Contact
raheelsanad90@gmail.com
01018263304

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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