Effect of Low Level Laser Therapy on Hamstring Muscle Tightness and Calf Muscle Spasticity in Cerebral Palsy Children.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- poplital angle test
研究概览
简要总结
Background :Spasticity is a motor disorder in children with cerebral palsy (CP) Cp is a non progress lesion in unmature brain lead to a group of chronic disorders that affect movement and posture development, may be accompanied by epilepsy, secondary musculoskeletal problems, deformaties and disturbances of sensation, perception, cognition, communication, and behavior Few studies demonstrate effectiveness of laser therapies in spasticity in cp.
Methodology : This study is randomize control trail aimes to evaluate the effect of low-level laser therapy (LLLT) on the spasticity of hamstring and calf muscle in children with CP over 12 session of intermittent laser exposures. Muscle tone , gross motor function, rang of motion (rom ) and poplital angle will evaluate before and after laser irradiation in 30 children with CP both geneder aged between two to six years old diaplegic clidren , exclusion children who take botox or done surgery . Muscles will irradiated with low-intensity diode laser pulses of 808-nm wavelength three times per week over one month follow up for one month.
详细描述
This is a randomized controlled study, in which the 30 children with diaplegic randomly divide into control and study groups by excel sheat on computer, each group include 15child. Each child will receive laser at a frequency of three sessions per week for 12 session, in addition to conventional physiotherapy program, while the control group have 15 child will receive conventional physiotherapy. Four variables will choose to detect the effect of laser therapy: (1) muscle tone, (2) range of motion (ROM) , (3) gross movement,(4) poplital angle assessment . These values will recorde in both groups before starting treatment and after the treatment period and after one month of stop treatment .
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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 (Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •spastic diaplegic children aged between 2 to 6years have spastic hamstring and calf muscle .
排除标准
- •for post-operative children , children who take botox, children with contracture or fixed deformity
研究组 & 干预措施
low level laser , physiotherapy
Instrumentation Diode laser device will use for biostimulation of the muscle fiber . The device has a wavelength of 808 nm and a power output 0-250 mW. parameters of laser : Wavelength 808 nm Power output 100 mW Spot size 0.0314 cm2 Power density 3,18 W/cm2 Treatment time per point 40 s Energy density per point 4,77 J/cm2 Energy per point 4 J 12 sessions for one month with traditional physiotherapy ( stretching , strenghthing exercises , trunk control , balance training , standing exercises , gait training .)
干预措施: low level laser therapy (Device)
physiotherapy
traditional physiotherapy ( stretching , strenghthing exercises , trunk control , balance training , standing exercises , gait training ) for one hour
干预措施: low level laser therapy (Device)
结局指标
主要结局
poplital angle test
时间窗: 2 months
clinical test
rom by Goniometer
时间窗: 2 months
clinical assessment
Modified Ashworth scale
时间窗: 2 months
scale to assets muscle tone
Modified Ashworth scale
时间窗: one month of treatment
scale to assets muscle tone
rom by Goniometer
时间窗: one month of treatment
clinical assessment
poplital angle test
时间窗: one month of treatment
clinical test
次要结局
- gross motor(2 months)
- gross motor(one month of treatment)
研究者
basma ragab
physiotherapist
National Institute of Laser Enhanced Sciences