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

August 21, 2026 updated by: Raheel Sanad

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt, 02
        • Recruiting
        • Abo EL resh hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

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
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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 monthes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
gross motor function will be assessed by Gross motor function measurement-88 scale
Time Frame: 3 monthes
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
3 monthes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Raheel Sanad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 15, 2026

Study Registration Dates

First Submitted

August 18, 2026

First Submitted That Met QC Criteria

August 21, 2026

First Posted (Actual)

August 25, 2026

Study Record Updates

Last Update Posted (Actual)

August 25, 2026

Last Update Submitted That Met QC Criteria

August 21, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Raheel _SI_2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan 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

IPD Sharing Time Frame

3 monthes

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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