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临床试验/NCT05775315
NCT05775315已完成不适用

Additional Effects of Visual Feedback Along With Action Observation Therapy on Balance, Mobility and Cognition in Cerebral Palsy

Riphah International University2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2022年9月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
Timed 10-meter walk test

研究概览

简要总结

the study aims to find the effectiveness of visual feedback along with action observation therapy in cerebral palsy. the effect of AOT on mobility, cognition and balance of the targeted population will be the intrest of the researcher

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 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Without visual impairment and visual field defects
  • Mini-Mental state examination for Children (MMC) score >25
  • GMFCS (gross motor function classification system) I-III
  • Children with Modified Ashworth Scale (MAS) less than 2

排除标准

  • Unable to walk
  • Children with severe co-morbidities

结局指标

主要结局

Timed 10-meter walk test

时间窗: 12 weeks

The test can be used to measure the gait ability and speed. The acceleration area 2.5m and deceleration area 2.5m can be marked on the ground as start and end point for the test. Participants are asked to walk for 15 minutes on comfortable flat floor at a comfortable speed and then the walking speed is recorded through stopwatch over 10 m between these points. The mean value of the three trials was used and expressed as m/s(14).

Mini Mental State Exam

时间窗: 12 weeks

It is a cognitive screening task and scoring system for 3 to 14 years old child (25). It is presented by 11 questions involving five basic cognitive abilities i.e. attention-concentration, orientation, registration, recall and language and constructive ability. The possible score range is from 0 to 37, from which 17 or lower score indicating as moderate to severe cognitive impairment of children.

Gross Motor Function Classification Scale (GMFCS)

时间窗: 12 weeks

Gross Motor Function measure (GMFM) is the valid and standard observational instrument to measure change in gross motor function in CP children. The tool consists of 66 items with 5 dimensions. These dimensions are the major motor functions i.e. supine/rolling, sitting, crawling/kneeling, standing and walking/running/jumping. Each task is rated according to the scoring guidelines i.e. higher score indicated better gross motor function. Each GMFM item is graded on 4-point scale i.e. 0 for unable to initiate the task, 1 for able to initiate the task, 2 for able to perform the task partially and 3 for able to perform the task completely. At the end these score summed up into total score. The component B,C,D and E of GMFCS will be used in this study respectively.

Pediatric Balance Scale (PBS)

时间窗: 12 weeks

PBS is a modified form of Berg Balance Scale (BSS) which was developed for balance measurement in CP child. It can be performed without specialized equipment and is easy to administrate. It includes 14 items with 5-level grading to assess the functional activities that child must safely and independently form at home, community, activities including sitting balance, sit to stand/stand to sit, transfer, stepping, reaching forward, reaching to floor, turning and stepping on and off at elevated surface. Each activity is rated according to scale from 0 to 4 i.e. 0 for unable to perform and 4 for able to perform without difficulty.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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