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Clinical Trials/NCT03983746
NCT03983746
Completed
Not Applicable

Randomized Controlled Trial

Cairo University1 site in 1 country45 target enrollmentJanuary 2, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Physical Therapy
Sponsor
Cairo University
Enrollment
45
Locations
1
Primary Endpoint
Functional Balance
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Introduction: Core stability exercises and treadmill training play a crucial role in physical therapy interventions and have an effect on balance in children with Down syndromes (DS), whether core stability exercises or treadmill training has more effect on improve balance has not been investigated yet. The aim of the study was to investigate the effect of core stability training versus treadmill exercises on balance in children with Down syndrome. Methods: Forty-five children with Down syndrome included in the study. The children aged 4-6 years, and they were equally divided randomly into three groups (A), (B) and (C). Group A received traditional physical therapy intervention strategies to facilitate the balance of participated children. Group (B) received same as the group (A), with additional core stability exercises training. Group (C) received same intervention strategies as group (A) in conjunction with a treadmill exercise program. The children's balance was evaluated using the Berg Balance Scale and the Biodex Balance System. Treatment sessions were for 60 min, thrice a week, for eight consecutive weeks.

Registry
clinicaltrials.gov
Start Date
January 2, 2019
End Date
April 15, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Reham Saeed Alsakhawi

Lecturer, Faculty of Physical Therapy

Cairo University

Eligibility Criteria

Inclusion Criteria

  • Able to recognize commands given to them,
  • Able to understand our verbal command and encouragement, and
  • Able to stand and walk independently without repeated falling

Exclusion Criteria

  • Any neurological or musculoskeletal disorders (signs of epilepsy and instability of atlantoaxial joint),
  • Any mobility disorders
  • Any cardiac anomalies
  • Any vision or hearing loss

Outcomes

Primary Outcomes

Functional Balance

Time Frame: 30 minutes

The Biodex Balance System (BBS) is used to adjust the stability of a suspended circular force plate. The force platform has a maximum of twenty degrees tilt in any direction when completely un-stabilized and determines the stability of participant based on the variance of the platform from the center. The Berg Balance Scale is a clinical assessment of functional balance. It consists of fourteen functional tasks of increasing difficulty, and each scored on a scale ranging from 0 to 4 (task is performed independently=4; unable to complete the task=0). The maximum possible score is fifty-six which indicating no identifiable balance difficulties.

Overall Stability Index

Time Frame: 30 minutes

The Biodex Balance System (BBS) is used to adjust the stability of a suspended circular force plate. The force platform has a maximum of twenty degrees tilt in any direction when completely un-stabilized and determines the stability of participant based on the variance of the platform from the center . The Berg Balance Scale is a clinical assessment of functional balance. It consists of fourteen functional tasks of increasing difficulty, and each scored on a scale ranging from 0 to 4 (task is performed independently=4; unable to complete the task=0). The maximum possible score is fifty-six which indicating no identifiable balance difficulties

Study Sites (1)

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