To compare the efficacy of Serial Casting and Botulinum Toxin A in Spastic Equinus in Children with Cerebral Palsy: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- 1) Passive Range of Motion (in degrees) of Ankle Dorsiflexion in Affected foot
研究概览
简要总结
Cerebral Palsy is a broad diagnosis which includes various disorders affecting the child’s ability to maintain posture and balance.
Spasticity is defined as an increase in muscle tone which is velocity dependent. It occurs due to damage to the pyramidal system in motor cortex in brain. Conservative strategies like physical therapy, occupational therapy, orthotics, and casting have a major role in improving motor abilities. Casting acts as a tone inhibitor which has show improvements in passive and active ankle dorsiflexion range of motion; however, equinus may occur again .Gastrocnemius insufficiency is the main factor in causing equinus gait which hampers the ambulation of children . The tone inhibiting ankle foot orthosis have not revealed much changes in equinus gait correction . An understanding of the maturity of gait is important in further management of spastic equinus gait. Based on results of previous studies, botulinum toxin and casting are two treatment modalities which have shown favorable outcomes for improvement in reduction of spasticity in equinus foot. There is a need of further research in understanding the efficacy of botulinum toxin A and serial casting in spastic equinus gait.
Rationale of the Study-There are no standard guidelines regarding treatment choice in spastic equinus. Due to lack of enough robust studies regarding efficacy of Injection Botulinum Toxin A and Serial Casting in improving equinus spasticity and increasing the ROM, there is a need of further research into these treatment modalities, and their appropriate usage. This study aims to compare the efficacy of Injection Botulinum Toxin A and Serial Casting in spastic equinus in children with CP. The findings of this study could aid in developing treatment recommendations when using these two modalities.
Aim- To compare the efficacy of Serial Casting and Injection Botulinum Toxin A in spastic equinus in children with cerebral palsy
Objectives
Primary objective-To assess and compare the changes in Active and Passive Dorsiflexion, between Serial Casting and Injection Botulinum Toxin -A groups
Secondary objective
-
To assess the change in level of Gross Motor Function Classification System (GMFCS)
-
To assess the change in spasticity, using Modified Ashworth Scale (MAS) and Modified Tardieu Scale (MTS)
-
To assess the change in heel to floor height
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 3.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Children with Cerebral Palsy with equinus gait 2)Age group 3-12 years 3)Child should be ambulatory 4)Child should have standing and trunk control 5)Grade II or III spasticity in plantar flexor muscles 6)Child enrolled under various Government Health Schemes like Ayushman Bharat.
排除标准
- •Children having spasticity in Hip Adductors 2)Grade I or I+ spasticity in affected plantar flexor muscles 3)Child with Ataxic Gait 4)Child with bleeding disorder 5)Presence of hip pathology/ bony deformities/ foot deformities/ uncontrolled seizures 6)Non ambulatory child 7)Refusal to take part in the study 8)Poor trunk control.
结局指标
主要结局
1) Passive Range of Motion (in degrees) of Ankle Dorsiflexion in Affected foot
时间窗: Baseline | 4 weeks | 12 weeks
2) Active Range of Motion (in degrees) of Ankle Dorsiflexion in Affected foot
时间窗: Baseline | 4 weeks | 12 weeks
次要结局
- 1) Gross Motor Function Classification System (GMFCS)(2) Modified Ashworth Scale (MAS))
研究者
Vikram Pratihast
All India Institute of Medical Sciences