Effect of Radial Extracorporeal Shock Wave and Peripheral Magnetic Stimulation on Upper Limb in Children With Spastic Hemiplegia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Change of the muscle tone of the wrist flexors
研究概览
简要总结
Hypotheses:
There will be an effect of radial extracorporeal shock wave therapy and peripheral magnetic stimulation on the following parameters, in children with spastic hemiplegia:
- Wrist flexors spasticity.
- Wrist joint range of motion.
- Hand grip muscles strength.
- Sensorimotor function of wrist and hand.
详细描述
Significance of the study:
Reducing muscle hypertonia or spasticity in order to regain independent mobility is an essential goal of a physiotherapeutical treatment in neuro-rehabilitation. The rapid normalization of the muscle tone is a criterion that can crucially influence the outcome of future rehabilitation or in training programs.
Purposes of the study:
To evaluate the effect of radial extracorporeal shock wave therapy and peripheral magnetic stimulation on the following parameters, in Children with Spastic Hemiplegia:
- Wrist flexors spasticity.
- Wrist joint range of motion.
- Hand grip muscles strength.
- Sensorimotor function of wrist and hand.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Spastic hemiplegic children will be included in this study.
- •The children ages will be ranged from 6-10 years chronologically.
- •Children will have wrist flexors degree of spasticity ranged from +1 to 2 on Modified Ashworth Scale.
- •The children will have Level III to Level IV according to the Manual Ability Classification System.
- •All children will be medically stable.
- •Children take their anti-spasticity medications.
- •All children will be able to follow instructions.
排除标准
- •• History of recent nonunion fracture of the upper extremities.
- •Neurological or orthopedic surgery in the upper extremities in the last 12 months before the study.
- •Received Botulinum toxin A injections in the last six months.
- •Fixed contractures and deformities.
- •Patients with a self-contained medical implant such as: a metal plate along the spastic limbs, pacemaker, cochlear implant, and so on.
- •Children with cognitive dysfunction.
- •Poor skin integrity.
结局指标
主要结局
Change of the muscle tone of the wrist flexors
时间窗: at the beginning and after eight weeks of the intervention
The muscle tone of the wrist flexors will be assessed with The Modified Tardieu Scale (MTS) . This test is done in the supine position, with head in midline, and is measured at 3 different velocities (V1, V2, and V3). V1: as slow as possible (slower than the natural drop of the limb segment under gravity. V2: speed of limb segment falling under gravity. V3: as fast as possible faster than the rate of the natural drop of the limb segment under gravity. Measuring R1 (the fast velocity movement of the wrist through the full ROM to determine the point of catch in the ROM), R2 (the passive ROM), and R2-R1 (dynamic component of spasticity).
次要结局
- Change of wrist extension range of motion (ROM)(at the beginning and after eight weeks of the intervention.)
- Change of handgrip strength(at the beginning and after eight weeks of the intervention.)
- Change of Functionality of wrist and hand(at the beginning and after eight weeks of the intervention.)
研究者
Hany Abdelaziz Saad
Principal investigator
Cairo University