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Completed

NCT Number: NCT03983746

Effect of Core Stability Exercises and Treadmill Training on Balance in Children With Down Syndrome

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.

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Key information

Conditions

Physical Therapy

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Therapy, Cairo University

Giza, Cairo Governorate, 12111, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

core stability exercises and treadmill training exercises

Device

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.

Other names: traditional physical therapy program

Primary outcomes

  1. 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.

  2. 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

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Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 12, 2019
Registry last updated
Jun 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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