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临床试验/NCT07733570
NCT07733570尚未招募不适用

Effects of Sensory Integration Therapy on Functional Mobility ,Balance and Gait Symmetry in Children With Spastic Hemiplegic CP :A Randomized Trial

Riphah International University0 个研究点目标入组 32 人开始时间: 2026年8月22日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
32
主要终点
Edinburgh visual gait score

研究概览

简要总结

The Goal of this Clinical Trial is to learn if a treatmnet called Sensory Integration Therapy (SIT) can Improve walking,Balance and movemnet in children with a type of cerebral palsy called spastic hemiplegic Cerebral Palsy .This Condition affects one side of body and make walking uneven.The study will include children between 5-12 year old .

The main Question this study aims to answer are :

Does adding SIT to regular physical therapy improve How symmetrically children walk? Does adding SIT to regular physical therapy improve balance and daily movements skills,compared with regular/conventional Physical Therapy Alone.

Researches will compare two group of children to see if SIT + Conventional Physical Therapy work better then Convential Physical therapy alone .

Participant will be palaced into one of two groups by chance one group will recieive SIT alone with COnventional PT,the other group will recieve Conventional Therapy Alone only.

Attend Therapy session 3 time a week for 8 week Be tested before and after the 8 week using simple movement and balence tests,including a walking assessment done By video .

详细描述

This study is a randomized controlled trial evaluating whether Sensory Integration Therapy (SIT), when combined with conventional physiotherapy, produces greater improvements in gait symmetry, functional mobility, and balance than conventional physiotherapy alone in children aged 5-12 years with spastic hemiplegic cerebral palsy (CP).

Thirty-two participants will be recruited using non-probability consecutive sampling and then randomly allocated into two equal groups. Group A (experimental) will receive SIT (25 minutes) followed by conventional physiotherapy (20 minutes) per session. Group B (control) will receive conventional physiotherapy alone (45 minutes) per session. Both groups will attend 3 sessions per week for 8 weeks. Treatment content will progress in complexity over four two-week blocks, moving from foundational sensory and mobility activities to advanced, community-level functional tasks.

Outcomes will be assessed using three standardized tools: the Gross Motor Function Measure (GMFM-88), the Pediatric Balance Scale (PBS), and the Edinburgh Visual Gait Score (EVGS), a video-based observational gait analysis tool particularly suited to detecting asymmetry between the affected and unaffected limbs in hemiplegic CP. Assessments will be conducted at baseline and following the intervention period.

This study addresses a gap in the literature, as most prior research on SIT in CP has focused on spastic diplegic subtypes, with comparatively little evidence specific to spastic hemiplegic CP or to gait symmetry as a primary outcome. Data will be analyzed using SPSS, with a mixed-design repeated-measures ANOVA used to evaluate the effects of time, group, and the group-by-time interaction, followed by post hoc analysis where indicated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
5 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 5-12 years diagnosed with spastic hemiplegic CP
  • GMFCS level I-III
  • able to follow simple commands

排除标准

  • Severe cognitive impairment
  • recent orthopedic surgery
  • uncontrolled seizures.

结局指标

主要结局

Edinburgh visual gait score

时间窗: 8 week

EVGS developed by Read and colleagues ,is an observational tool that evaluate gait quality in children with CP across 17 parameters and 6 body segment with score from 0-34 per limb ,where lower scores indicate near normal gait and higher score reflect greater abnormality.. It show Excellent reliability ICC of 0.947(95%) with a Cronbach's alpha value of 0.936,with minimal detectable change of 4.78 to 6.0 points.The EVGS showed good construct validity with a negative correlation with the GMFM-66 (r = -0.50 to -0.70), it also show moderate agreement 52% to 73%, with 3D gait analysis ,supporting criterion validity. In hemiplegic CP, useful for assessing gait symmetry between limbs.The maximum total Score per extermity is 34, the lower then maximum indicate less gait deviation.

次要结局

  • Gross Motor Function Measure -88(GMFM-88)(8 week)
  • Pediatric Balance Scale (PBS)(8 week)

研究者

申办方类型
Other
责任方
Sponsor

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