Feasibility Of Oral Sensorimotor Stimulation And Sequenced Trunk Co-Activation On Oropharyngeal Dysphagia In Children With Spastic Cerebral Palsy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Oral motor skills
研究概览
简要总结
Children with CP encounter swallow and feeding impairments, especially in infancy and childhood with long meal times with late development of oral motor skills resulting in poor growth.
详细描述
this study will be conducted to explore the feasibility of oral sensorimotor stimulation combined with sequenced trunk co-activation on oropharyngeal dysphagia in children with spastic quadriplegic CP.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Months 至 48 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosed as spastic quadrilepgic CP
- •Both genders
- •Aged from 12 to 48 months
- •Scored ≤ 10 on an initial evaluation of Oral Motor Assessment Scale.
- •Having at least a problem of oral motor functions (drooling, swallowing, and/or sucking); independent feeding
- •Grade ≥ 2 spasticity according to the MAS
- •Level IV and V motor function according to the GMFCS-R&E.
- •Partial head and trunk control.
排除标准
- •Gum and/or dental problems
- •Congenital problems of mouth and soft plate
- •Uncontrolled seizures
- •Any metabolic disorders
- •Cardiopulmonary disorders
- •Significant mental problems.
研究组 & 干预措施
conventional physical therapy training
received 90 minutes conventional physical therapy training focused on regaining typical movement, prohibiting abnormal muscle tone, promoting postural reactions and enhancing postural mechanisms.
干预措施: conventional physical therapy training (Other)
oral stimulation
received 30 minutes of oral motor training five days week. The training included oral stimulation (facilitation) conducted before the child's actual meal time. The designed protocol comprised modified perioral and intraoral maneuvers based on Fucile's protocol
干预措施: conventional physical therapy training (Other)
oral stimulation
received 30 minutes of oral motor training five days week. The training included oral stimulation (facilitation) conducted before the child's actual meal time. The designed protocol comprised modified perioral and intraoral maneuvers based on Fucile's protocol
干预措施: oral motor training. (Other)
结局指标
主要结局
Oral motor skills
时间窗: period of the treatment was 4 successive months
The Oral Motor Assessment Scale is a reliable and accurate scale frequently used to assess oral-motor skills in young patients with neurological disorders. It is a useful tool that can be used in assessment and interventional studies. The full assessment takes approximately 20 minutes to be completed for each child giving score as passive (0), sub-functional (1), semi-functional (2) and functional (3) with higher scores represent better oral-motor skills
次要结局
- - Physical growth(period of the treatment was 4 successive months)
- - Gross motor function(period of the treatment was 4 successive months)
- - Segmental trunk control(period of the treatment was 4 successive months)
研究者
Amira M Abd-elmonem, PHD
principle investigator
Cairo University