Effects of Physical Training Following Selective Dorsal Rhizotomy on Trunk Control, Selectivity and Upper Extremity Function of Non-ambulant Children With Bilateral 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
- 90
- 试验地点
- 2
- 主要终点
- Segmental trunk control
研究概览
简要总结
Children with spastic bilateral cerebral palsy are late developers. delayed gross and fine motor development require early intervention to improve the child performance and avoid secondary impairments.
详细描述
increased tone of lower extremity muscles interfere with the child sitting posture and trunk control. delayed sitting and lack of trunk control contribute to the impairments of upper extremity functions.
selective dorsal rhizotomy is a surgical procedure to control increased tone of the lower extremities. Therefore, the current study is carried out to investigate the effects of selective dorsal rhizotomy on trunk control, selectivity and upper extremity function of non-ambulant children with bilateral spastic cerebral palsy
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)
盲法说明
Random allocation of participants will be completed using a random number generator, with the allocation to either the control or selective dorsal rhizotomy group being concealed. The random numbers are generated by the principle physical therapists with every alternate number being marked either "1" or "2." However, the receptionist was blinded to the interventions assigned to group 1 (control group) and group 2 (SDR group). During allocation, every parent/legal guardian is asked to pick up one enclosed envelope from a box containing numbers from 1 to 30. Then, they are allocated to either group 1 or group 2 to minimize the risk of allocation bias.
入排标准
- 年龄范围
- 4 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CP, spastic diplegia
- •4-7 years of age
- •On Level IV-V on Gross Motor Function Classification System
- •Partial trunk control (sitting with support).
排除标准
- •Structural non-reducible deformities or musculoskeletal surgery in the lower extremities in the past 12 months
- •Ankle clonus
- •Exaggerated deep tendon reflex in the legs
- •Babinski sign;
- •Moderate to severe signs of dystonia, athetosis or ataxia.
研究组 & 干预措施
control group
control group
干预措施: physical therapy excercises (Other)
SDR-group
selective dorsal rhizotomy
干预措施: selective dorsal rhizotomy (Other)
control group
control group
干预措施: Standard Orthotic Management (Other)
SDR-group
selective dorsal rhizotomy
干预措施: physical therapy excercises (Other)
SDR-group
selective dorsal rhizotomy
干预措施: Standard Orthotic Management (Other)
结局指标
主要结局
Segmental trunk control
时间窗: period of the treatment was 4 successive months
The Segmental Assessment of Trunk Control is applied to assess upright trunk postural control in sitting position based on subdividing the trunk into 6 segments. The head/trunk control is acquired segment by segment if upright sitting posture can be maintained under three conditions including: static control at static position, active control while the child moves the head and/or arm and reactive control after external perturbation.The trunk segments according to the scale include: head/neck, thoracic (upper, mid and lower) and lumbar (upper and lower) segments. It is an ordinal scale with a grade 1 to 7 is assigned for each segment with the score 7 indicates that the infant can't retain independent sitting (no hand support). A score of 8 is given as full trunk control is gained.
Gross motor function
时间窗: period of the treatment was 4 successive months
The gross motor function measure-88 is a valid and reliable criterion referenced instrument; is currently used to evaluate the motor function over time in individuals with cerebral palsy.
次要结局
- upper extremity function(period of the treatment was 4 successive months)
研究者
Amira Mahmoud Abd-elmonem
Assist Prof. Physiacl therapy for pediatric department, faculty of physical therapy , Cairo university
Cairo University