Effects of Therapeutic Dosing Through Enriched Environment on Gross Motor Function and Spasticity in Spastic Quadriplegic Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Gross Motor Function
研究概览
简要总结
This study focuses on how enriched environment along with the traditional physical therapy improves the gross motor function in spastic quadriplegic cerebral palsy children. And how much dosing is required to gain that clinically significant improvement.
详细描述
There is still a blurred area regarding dosage parameter in cerebral palsy rehabilitation. This study is focused primarily on the fact that level appropriate selection of time, type, frequency, and intensity of intervention (sensory and motor) plays a very vital role in developing gross motor functions. Secondly it is very important to establish the impact of enriched environmental inputs and foster parent capacity as an early intervention taking into account cerebral palsy (CP) specific positioning and handling along with level appropriate sensory inputs.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 7 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age Group between 7 months to 5 years.
- •Spastic Quadriplegia
- •Gross Motor Function Classification System (GMFCS) level IV and V
- •Modified Ashworth Scale (MAS): level 2
- •Both Gender
排除标准
- •History of fits
- •Medications
- •Dislocation and fracture
- •Visual/Auditory Impairment
- •Patients taking therapy from multiple places
研究组 & 干预措施
Group A
Intervention Given: Enriched Environment (age-appropriate) + NDT + Therapeutic Dosing
干预措施: Enriched Environment (Other)
Group B
Traditional Physical Therapy consisting of NDT
干预措施: Traditional Physcial Therapy (Other)
结局指标
主要结局
Gross Motor Function
时间窗: 5 months
To check the improvement in gross motor function on Gross Motor Functional Measure scale of spastic quadriplegic cerebral palsy children. The scoring system of this scale is divided into five dimensions of gross motor function:(a) lying and rolling, (b) sitting, (c) crawling and kneeling, (d) standing, and (e) walking, running and jumping. The scoring is done on four points: 0=does not initiate 1. = initiates 2. = partially completes 3. = completes Higher scores mean better outcome whereas low scores show little to no improvement in gross motor function.
次要结局
- Spasticity(5 months)