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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07785011
Enrollment
40
Registered
2026-08-25
Start date
2025-09-15
Completion date
2026-10-15
Last updated
2026-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Down Syndrome

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.

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.

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

Sponsors

Raheel Sanad
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
3 Years to 5 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
balance measured by Stability Score of the Clinical Test of Sensory Interaction on Balance(CTSIB) using HUMAC Balance system3 monthesbalance 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

MeasureTime frameDescription
gross motor function will be assessed by Gross motor function measurement-88 scale3 monthesThe 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

Countries

Egypt

Contacts

CONTACTraheel sanad, doctoral
raheelsanad90@gmail.com01018263304

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 26, 2026