Effect of the Sensory Integration Approach on Balance and Motor Coordination in Children With Down Syndrome

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT05583565

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Down Syndrome	Other: sensory integration approach Other: traditional physical therapy program	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effect of the Sensory Integration Approach on Balance and Motor Coordination in Children With Down Syndrome

Actual Study Start Date :

May 14, 2021

Actual Primary Completion Date :

Dec 8, 2021

Actual Study Completion Date :

Feb 12, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: study group receiving sensory integration approach	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
Active Comparator: control group receiving conventional physical therapy	Other: 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 ).

Arm

Intervention/Treatment

Experimental: study group

receiving sensory integration approach

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

Active Comparator: control group

receiving conventional physical therapy

Other: 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 ).

Outcome Measures

Primary Outcome Measures

balance [6 months]
measured by using BOTS scale

Secondary Outcome Measures

coordination [6 months]
measured by using BOTS scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 10 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CairoU	Giza		Egypt	11432

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shimaa Mohamed Reffat, lecturer at physical therapy faculty, Cairo University

ClinicalTrials.gov Identifier:

NCT05583565

Other Study ID Numbers:

sensory integration

First Posted:

Oct 17, 2022

Last Update Posted:

Oct 17, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Shimaa Mohamed Reffat, lecturer at physical therapy faculty, Cairo University

trisomy 21, Neurodevelopmental disorder

Additional relevant MeSH terms:

Down Syndrome

Syndrome

Study Results

No Results Posted as of Oct 17, 2022