Back to resultsEffect of the Sensory Integration Approach on Balance and Motor Coordination in Children With Down Syndrome
Primary Purpose
Down Syndrome
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
sensory integration approach
traditional physical therapy program
Sponsored by
About this trial
This is an interventional treatment trial for Down Syndrome focused on measuring trisomy 21, Neurodevelopmental disorder
Eligibility Criteria
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
Sites / Locations
- CairoU
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
study group
control group
Arm Description
receiving sensory integration approach
receiving conventional physical therapy
Outcomes
Primary Outcome Measures
balance
measured by using BOTS scale
Secondary Outcome Measures
coordination
measured by using BOTS scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05583565
Brief Title
Effect of the Sensory Integration Approach on Balance and Motor Coordination in Children With Down Syndrome
Official Title
Effect of the Sensory Integration Approach on Balance and Motor Coordination in Children With Down Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
May 14, 2021 (Actual)
Primary Completion Date
December 8, 2021 (Actual)
Study Completion Date
February 12, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Down Syndrome
Keywords
trisomy 21, Neurodevelopmental disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
study group
Arm Type
Experimental
Arm Description
receiving sensory integration approach
Arm Title
control group
Arm Type
Active Comparator
Arm Description
receiving conventional physical therapy
Intervention Type
Other
Intervention Name(s)
sensory integration approach
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
traditional physical therapy program
Intervention Description
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 ).
Primary Outcome Measure Information:
Title
balance
Description
measured by using BOTS scale
Time Frame
6 months
Secondary Outcome Measure Information:
Title
coordination
Description
measured by using BOTS scale
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CairoU
City
Giza
ZIP/Postal Code
11432
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of the Sensory Integration Approach on Balance and Motor Coordination in Children With Down Syndrome
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