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临床试验/NCT03983746
NCT03983746已完成不适用

Randomized Controlled Trial

Cairo University2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2019年1月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
2
主要终点
Functional Balance

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
4 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

traditional physical therapy program (control group)

Experimental

fifteen children with DS received a traditional exercises program with instructions to the children for 60 minutes aiming to improve posture control and balance

干预措施: core stability exercises and treadmill training exercises (Device)

结局指标

主要结局

Functional Balance

时间窗: 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

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Reham Saeed Alsakhawi

Lecturer, Faculty of Physical Therapy

Cairo University

研究点 (2)

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