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临床试验/CTRI/2024/08/071909
CTRI/2024/08/071909尚未招募不适用

Evaluation of Postural Control in Children with Neuro-motor Disorders with and without visual impairment: A comparative study

MGM School of Physiotherapy1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2024年8月13日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
52
试验地点
1
主要终点
Centre of Pressure (CoP) trajectory in Force plate

研究概览

简要总结

  1. The procedure and purpose of the study will be explained to all the parents.

2. Consent will be obtained from both the child and the parent for the study.

3. After screening for the inclusion and exclusion criteria, the first child who is diagnosed with any Neuro-motor Disorders without any visual impairment will be recruited. This child will form Group A.

  1. The next child will be recruited who is diagnosed with the same type of Neuromotor Disorder along with vision impairment. The child should also match the age, gender, and Body Mass Index of the previous child. This child will form Group B.

5. This procedure will continue till there are 26 children in Group A and Group B each.

6. Postural Control will be assessed for all the children in both groups

Postural Control in the Centre of Pressure (CoP) trajectory in sway will be assessed for all the children in both groups.

For children with visual impairments, alternate visual and verbal tasks will be given and provided with lots of breaks. For braille learners, the expected progression of numeracy, reading, and writing, is not the same as the progression of the same skills in sighted peers. If needed, enlarge reading materials ahead of time off. The copies have high contrast, with photocopies, making sure to present only one page at a time, so that there is no interference from text showing through from the page underne

 Postural Control assessment will include

1.                  Centre of Pressure (CoP) trajectory in Sway which will be analysed by using Matlab software for postural transition for dynamic stability.

2.                  Paediatric Balance test for overall balance.

3.                  Functional reach test

4.                  Timed up and go test for anticipatory and reactive postural control

 The Postural Control assessment data will be analysed by SPSS.

  1. A paired T-test will be used to assess the Age and body weight of the participants within the

group.

  1. Unpaired T-Test will be used to assess the age, and body weight of the participants between two

groups.

  1. For scales and outcome measures, the Wilcoxon sign test will be used for evaluating within the

Same group of participants.

  1. Mann Whitney - U- test will be used for evaluating the scales and outcome measures for the participants between groups.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

年龄范围
7.00 Year(s) 至 14.00 Year(s)(—)
性别
All

入选标准

  • Age group 7-14 years, including both boys and girls
  • Children diagnosed with Neuro-motor disorders.
  • Children with Gross Motor Function Classification System (GMFCS) score between Level
  • Level 3 ( ie. Walking independently to walking with hand held mobility device)
  • Children with impaired vision and disability certificate. (not a normal eyesight and not more than 70%).

排除标准

  • 1.Typically developing children 2.Any muscular impairment involving Spine, Lower extremity and Upper extremity, congenital malformation of physical order. 3.Children with hearing impairments 4.Children with severe cognitive deficit (no understanding of the simple orders of the test) • Children with visual acuity to 3/60 (0.05).

结局指标

主要结局

Centre of Pressure (CoP) trajectory in Force plate

时间窗: 20-30 minutes

次要结局

  • Pediatric Balance Scale(15-20 minutes)
  • Time Up and Go test(5 minutes)
  • Functional reach test(5 minutes)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Laxmi Simanlal

MGM School of Physiotherapy

研究点 (1)

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