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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05583565
Other study ID # sensory integration
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 14, 2021
Est. completion date February 12, 2022

Study information

Verified date October 2022
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Down syndrome can be characterized by global mental and physical dysfunction or isolated gait, cognition, growth, or sensory disturbances. This study was conducted to investigate the effect of the sensory integration approach on improving balance and motor coordination in children with Down syndrome.


Description:

Thirty children were enrolled in this study and randomly assigned to two groups: Group A received (sensory integration therapy program and training in physical therapy) and received group B (physical therapy training program only). Motor coordination and balance were assessed before and after exercise for all children using Bruininks - Oseretsky Test of Motor Proficiency - 2nd Edition.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date February 12, 2022
Est. primary completion date December 8, 2021
Accepts healthy volunteers No
Gender All
Age group 5 Years to 10 Years
Eligibility Inclusion Criteria: - children with Down syndrome - the ages of five and ten years who can walk - their IQ is more than 75% Exclusion Criteria: - they had a serious neurological disorder (epilepsy), orthopedic problems, upper or lower limb surgery, vision or hearing problems, use of medications that impair behavior or attention, and suffered from advanced intellectual disability

Study Design


Related Conditions & MeSH terms


Intervention

Other:
sensory integration approach
Sensory integration refers to how the nervous system receives messages from multimodal sensory information systems to maintain balance, posture, and balance by monitoring head movement and stabilizing the eyes about the environment
traditional physical therapy program
conventional physiotherapy training programs such as the following: 1)Hand function training by locating the Grading of the hand and training this level until it is well developed to transfer to the next level according to 8 parameters (partner's height-shape-weight-texture -reaction time-speed-accuracy-number of trials). 2) equilibrium training by promoting posture reaction. 3)ADL activity training (nutrition training-dressing training-toilet training). 4) Functional skill training through walking (walking on sand, weight on legs, and Climbing stairs ).

Locations

Country Name City State
Egypt CairoU Giza

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary balance measured by using BOTS scale 6 months
Secondary coordination measured by using BOTS scale 6 months
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