NCT05583565

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 14, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 17, 2022

Completed
Last Updated

October 17, 2022

Status Verified

October 1, 2022

Enrollment Period

7 months

First QC Date

August 30, 2022

Last Update Submit

October 12, 2022

Conditions

Keywords

trisomy 21, Neurodevelopmental disorder

Outcome Measures

Primary Outcomes (1)

  • balance

    measured by using BOTS scale

    6 months

Secondary Outcomes (1)

  • coordination

    6 months

Study Arms (2)

study group

EXPERIMENTAL

receiving sensory integration approach

Other: sensory integration approach

control group

ACTIVE COMPARATOR

receiving conventional physical therapy

Other: traditional physical therapy program

Interventions

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

study group

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 ).

control group

Eligibility Criteria

Age5 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • children with Down syndrome
  • the ages of five and ten years who can walk
  • their IQ is more than 75%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CairoU

Giza, 11432, Egypt

Location

MeSH Terms

Conditions

Down SyndromeNeurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, InbornMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer at physical therapy faculty

Study Record Dates

First Submitted

August 30, 2022

First Posted

October 17, 2022

Study Start

May 14, 2021

Primary Completion

December 8, 2021

Study Completion

February 12, 2022

Last Updated

October 17, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations