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NCT Number: NCT07785011

Effect of Sensory Integration on Gross and Balance on 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.

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Key information

Conditions

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

Age range

3 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

raheel sanad, doctoral

CONTACT

[email protected]

01018263304

Sponsors and collaborators

Lead sponsor

Raheel Sanad

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 25, 2026
Registry last updated
Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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