Effects of Neuromuscular Electrical Stimulation With and Without Dynamic Bracing on Lower Extremity Spasticity and Quality of Movement in Children With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Modified Ashworth Scale
研究概览
简要总结
The study aims at comparing Neuromuscular electrical Stimulation with and without dynamic bracing on spasticity and movement quality of lower limb in Children with Cerebral Palsy
详细描述
Cerebral palsy (CP) is a lifelong motor impairment caused by an early brain injury and affects 2-3 per 1,000 live births. It is a complex medical condition that negatively impacts cognition, language, sensations, movement, and gait patterns. It is normally carried out using a comprehensive approach that incorporates numerous approaches targeted at minimizing symptoms and improving functional outcomes.
NMES (Neuromuscular and Muscular Electrical Stimulation) is an instrument that provides electrical impulses to nerves, causing muscles to contract, while dynamic bracing use muscle power to pre-compress soft tissue to produce the high forces required to control specific pathological diseases.
The hip adductors, the knee flexor muscles, and the ankle and foot muscles (gastrocnemius and soleus may experience increased tone, causing the ankles to be held in a plantar-flexed (pointed downward) position) are targeted with NMES in the lower extremity to reduce the spasticity & improve the quality of movement in CP children. Investigating how combining NMES with dynamic bracing benefits lumbar disc bulge patients adds to the growing body of evidence supporting multimodal treatment.
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
- Double (Participant, Outcomes Assessor)
盲法说明
participants and outcome assessors will be kept blind about the intervention which the patients will be receiving
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 5 to 12 years.
- •Able to walk with or without an assistive device. Classification as level I-II on the Gross Motor Functional Classification System (GMFCS).
- •Able to stand with or without support for 1 minute.
- •Classification as levels I-III on the Manual Ability Classification System (MACS); and the ability to follow and accept verbal instructions.
- •Muscle tone scored ≥2, according to Modified Ashworth Scale.
排除标准
- •Orthopedic Surgical intervention (e.g. tendon lengthening in lower limb) within the previous 12 months
- •Treatment with botulinum toxin in the calf muscles within the previous 6 months
- •Presence of structural deformities at the lower limbs and trunk, or instability in the ankle joint, which could compromise the child's safety and performance of the motor task
- •Severe affective or psychiatric impairments;
- •Serious vision or hearing problems
- •Any neurological impairment (epilepsy or any other disease that would interfere with physical activity)
结局指标
主要结局
Modified Ashworth Scale
时间窗: baseline and 6 weeks
The scale is used to measure spasticity minimum score is 0 and maximum score is 4
Observable Movement Quality Scale
时间窗: baseline and 6 weeks
it is used assess the movement quality in children Minimum Score: 0 (indicating the poorest movement quality) and maximum is 24
Physicians Rating Scale
时间窗: baseline and 6 weeks
it is used to objectively documenting the hip, knee, ankle and foot changes in children with CP. Minimum Score: 0 (indicating no impairment or lowest severity) and Maximum score is 7
次要结局
未报告次要终点