NCT06036069

Brief Summary

Children had Down syndrome often have impaired balance and postural control and result as less active than their peers that can lead to reduced quality of life and movement skills. Effects of physical activity may be important in preventing falling risk and health consequences in those children

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

September 2, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

October 15, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2024

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2024

Completed
Last Updated

October 13, 2023

Status Verified

October 1, 2023

Enrollment Period

3 months

First QC Date

September 2, 2023

Last Update Submit

October 11, 2023

Conditions

Keywords

Children; Core Stability Exercises; Down Syndrome; Whole Body Vibration

Outcome Measures

Primary Outcomes (1)

  • Biodex Balance System

    it is a reliable and objective assessment in order to quantify dynamic balance

    before intervention and after 12 weeks of intervention

Secondary Outcomes (1)

  • Hand-held dynamometer

    before intervention and after 12 weeks of intervention

Study Arms (3)

Conventional physical therapy group

EXPERIMENTAL

It consisted of 20 children received conventional physical therapy

Other: Conventional physical therapy

Core stability exercises group

EXPERIMENTAL

It consisted of 20 children received conventional physical therapy and core stability exercises

Other: Conventional physical therapy

Whole body vibration

EXPERIMENTAL

It consisted of 20 children received conventional physical therapy and whole body vibration exercises

Other: Conventional physical therapy

Interventions

* Standing with feet together while the therapist was sitting behind and manually locking the child knees. * Step standing with the therapist behind the child. * High step standing and trying to keep balanced. The child stood on exercise mattress. * Single leg stance "unilateral standing" with assistance. The child was standing on exercise mattress. * Standing on a declined surface by using wedge. The child was standing on wedge towards the descending direction. * Standing with manual locking of the knees. * Changing position. * Gait training. * Static and dynamic muscle contraction.

Also known as: Physical therapy program
Conventional physical therapy groupCore stability exercises groupWhole body vibration

Eligibility Criteria

Age10 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Aged between 10 to 16 years.
  • Able to recognize commands given to them.
  • Understand our verbal command and encouragement.
  • Stand and walk independently without repeated falling.

You may not qualify if:

  • Children with any neurological (signs of epilepsy and instability of atlantoaxial joint).
  • Musculoskeletal, or mobility disorders.
  • Cardiac anomalies.
  • Vision or hearing loss.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ragaee Saeed Mahmoud

Giza, Faisal, Egypt

RECRUITING

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Single (outcomes Assessor)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized control study
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

September 2, 2023

First Posted

September 13, 2023

Study Start

October 15, 2023

Primary Completion

January 15, 2024

Study Completion

January 20, 2024

Last Updated

October 13, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations