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

NCT07785011 | Recruiting DMC

• 1 other identifier: Raheel _SI_2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Down Syndrome

Outcome Measures

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

  3 monthes

Secondary Outcomes (1)

• gross motor function will be assessed by Gross motor function measurement-88 scale

  3 monthes

Study Arms (2)

CONTROLLED GROUP

EXPERIMENTAL

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

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.

Behavioral: BALANCE AND SENSORY INTEGRATION

Interventions

BALANCE AND SENSORY INTEGRATION BEHAVIORAL

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

CONTROLLED GROUP; STUDY GROUP

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Raheel Sanad: lead

Study Sites (1)

Abo EL resh hospital

Cairo, 02, Egypt

RECRUITING

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Central Study Contacts

raheel sanad, doctoral

CONTACT

01018263304; raheelsanad90@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physiotherapist

Model Details: 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 Record Dates

• First Submitted: August 18, 2026
• First Posted: August 25, 2026
• Study Start: September 15, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: August 25, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 3 monthes

Locations

EG (1)