跳至主要内容
临床试验/NCT04925102
NCT04925102Unknown不适用

Prediction of Recovery in Spastic Cerebral Palsy.

Riphah International University1 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2021年6月14日最近更新:
适应症

试验速览

阶段
不适用
入组人数
125
试验地点
1
主要终点
Modified Ashworth scale

研究概览

简要总结

Until now, for children with cerebral palsy (CP) , diagnostic and some prognostic predictive machine learning studies have been conducted, but prognostic studies targeted specific milestone according to specific gross motor function measure (GMFCS) levels; such as walking and running predictors at GMFCS II and III and GMFCS II respectively, and not covered specific types of cerebral palsy. Predictions studies were limited by the lack of specificity of child and family characteristics was not taken into the account prospectively.

It is therefore the utmost need to support clinical decision making by predicting the recovery in spastic cerebral palsy. Recovery predictive factors can play an important role for this purpose. Thus, this study aims to predict the recovery in spastic cerebral palsy according to all GMFCS level by means of a prediction index/model.

详细描述

Spasticity is often considered as the main cause of functional limitation in cerebral palsy (CP) children. The main feature of cerebral palsy is the impaired development of gross motor functions in children. Gross motor functions are considered as an indicator of the overall prognosis of cerebral palsy as these are closely associated with other impairments in the cerebral palsy child such as auditory, cognitive or visual impairments. The gross motor function measure (GMFM) tool is most widely used to assess motor function, severity and treatment response of children with cerebral palsy. The five levels of GMFCS have been widely employed in cerebral palsy children less than 12 years of age with the focus on sitting and walking abilities of the child. Literature confirmed the importance of addressing the gross and fine motor skills in cerebral palsy children. Childhood factors that predict the participation of young adults with cerebral palsy in domestic life include; intellectual disability, low manual ability, limited motor capacity and epilepsy. Moreover, CP child primary and secondary impairments, co-morbidities, their adaptive behaviour, family, rehabilitation services all are determinants of changes in the gross motor ability of the child and their participation in daily routine activities. Thus, all these determinants need to be considered while planning the intervention for a cerebral palsy child and at the time outcome evaluation as well. Good prognostic predictors for ambulation in cerebral palsy children were identified through meta-analysis of observational studies which includes; independent sitting at 2 years of age, epilepsy, absence of intellectual disability and visual impairment. Machine learning (ML) approaches have been increasingly used in cerebral palsy research. Jing Zhang et al identified GMFCS and intellectual capacity as associated factors of self-care activity development, it was also mentioned that GMFCS has a role in mobility activities development. A predictive machine learning model was developed to highlight the factors associated with intellectual disability in the cerebral palsy population of the teenager, with the sensitivity, specificity and average accuracy of 78%. The result of this model confirmed the significant association of gross motor function, poor manual abilities and epilepsy with profound intellectual disability.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Cerebral palsy children with positive score 1 on items 3 and 4 of Hypertonia Assessment Tool (HAT).
  • Spastic cerebral palsy children with any functional ability level(Gross Motor Function Classification System (GMFCS) levels I-V)

排除标准

  • Children of any other type of cerebral palsy
  • Not willing to participate

结局指标

主要结局

Modified Ashworth scale

时间窗: 12 weeks

Modified Ashworth scale (MAS) is used for the assessment of spasticity. Muscle tone is quantified in MAS by the assessment of the resistance of the spastic muscles. It is similar to Ashworth but adds a 1+ scoring category to indicate resistance through less than half of the movement. Score range from 0-4, with 6 choices. 0 indicates, no increase in the muscle tone and 4 indicates rigidity of the affected part. Up to 12 weeks

Gross motor function measure

时间窗: 12 Weeks

The Gross Motor Function Measure (GMFM) is used to assess change in gross motor function in children with cerebral palsy aged 5 months to 16 years of age. The original GMFM version has 88 items each scored on a 4-point ordinal scale of 0 to 3, where 0 indicates that the child does not initiate the task; 1 indicates that the child initiates the task (completes \< 10% of the activity); 2 indicates that the child partially completes the task (completes from 10 to 99% of the activity), and 3 indicates that the child completes the task (100%). Up to 12 weeks

Functional Independence Measure for Children

时间窗: 12 weeks

Functional Independence Measure (FIM) is an 18-item, 7-level ordinal scale instrument that measures a child's consistent performance in essential daily functional skills. FIM is categorized into 2 main functional streams: "Dependent" (i.e; requires helper: scores 1-5) and "Independent" (i.e; requires no helper: scores 6-7). Scores 1 (total assistance) and 2 (maximal assistance) belonged to the "Complete Dependence" category. Scores 3 (moderate assistance), 4 (minimal contact assistance), and 5 (supervision or set-up) belonged to the "Modified Dependence" category. Scores 6 (modified independence) and 7 (complete independence) belonged to the "Independent" category. Up to 12 weeks

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 (1)

Loading locations...

相似试验