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临床试验/CTRI/2024/12/078074
CTRI/2024/12/078074尚未招募不适用

Effect of rhythmic stabilization on gait parameters and Dynamic balance in children with down syndrome

MRIIRS1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年12月23日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
MRIIRS
入组人数
40
试验地点
1
主要终点
1. Cadence,

研究概览

简要总结

This study aims to find out the effect of rhythmic stabilization on gait parameters and dynamic balance in children with Down syndrome.

Children with Down syndrome have altered gait patterns and balance control after even achieving it at a later age due to motor delay. This could be because of poor tone and ligament laxity resulting in delayed milestones. Possibly children can have better dynamic balance control and improved gait pattern after the intervention with rhythmic stabilization (proprioceptive neuromuscular function). It is assumed for improving the spatiotemporal and kinematic gait parameters with an increase in stride length, step length, velocity, and cadence and a decrease in step width. Also, the dynamic balance may improve with an increase in balance scores after intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
4.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • Subjects i.e. children with diagnosed cases of Down syndrome, both male and female will be taken.
  • Children between 4-10 years of age,
  • Consent from parents for the study and video recording,
  • Ability to follow the researchers’ and guardians’ instructions.

排除标准

  • Severe and profound Intellectual disability in Down syndrome children i.e. IQ less than
  • (Right of the Person with Disability act.,
  • Severe and profound Vision or hearing impairment,
  • A major history of disease or surgery or Recent history of any trauma which can hinder mobility and walking,
  • Any musculoskeletal condition hinders mobility and walking (eg: fracture, soft tissue injury),
  • Significant medical or surgical co-morbidities which hinder walking,
  • Uncontrolled seizures disorder and Uncooperative patients.

结局指标

主要结局

1. Cadence,

时间窗: baseline and | after 8 week (post intervention)

2. Velocity,

时间窗: baseline and | after 8 week (post intervention)

3. Stride length,

时间窗: baseline and | after 8 week (post intervention)

4. Step length,

时间窗: baseline and | after 8 week (post intervention)

5. Step width

时间窗: baseline and | after 8 week (post intervention)

Kinematic parameters: Joint angles in the sagittal plane in degree

时间窗: baseline and | after 8 week (post intervention)

1. Hip flexion and extension angles

时间窗: baseline and | after 8 week (post intervention)

2. Knee flexion and extension angles

时间窗: baseline and | after 8 week (post intervention)

3. Ankle dorsiflexion and planterflexion angles

时间窗: baseline and | after 8 week (post intervention)

Balance –

时间窗: baseline and | after 8 week (post intervention)

1. Time up and go test

时间窗: baseline and | after 8 week (post intervention)

2. Time up and down stairs test

时间窗: baseline and | after 8 week (post intervention)

3. Pediatric balance scale

时间窗: baseline and | after 8 week (post intervention)

次要结局

  • NA(NA)

研究者

发起方
MRIIRS
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

NUSRAT JAHAN

MANAV RACHNA INTERNATIONAL INSTITUTE OF RESEARCH AND STUDIES

研究点 (1)

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