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临床试验/NCT03771599
NCT03771599Unknown不适用

The Effects of Traditional Massage on Spasticity and Activity of Children(2 to 10 Years) With Cerebral Palsy

Isra University2 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2016年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
86
试验地点
2
主要终点
Modified Ashworth scale

研究概览

简要总结

The study has been conducted to see the effects of traditional massage on spasticity and activity of children with cerebral palsy (CP). It is a randomized controlled trial having two groups, control and intervention. Both groups received routine physical therapy treatment comprising stretching of tight muscles, strengthening of weak muscles, positioning and handling. Intervention group also received traditional massage in addition to routine physical therapy. Caregivers were trained to perform routine physical therapy treatment and traditional massage at home. Data was collected using a structured questionnaire, Modified Ashworth Scale (MAS), Gross Motor Function Classification System (GMFCS), Gross Motor Function Measure (GMFM) and CPChild Caregiver Priorities & Child Health Index of Life with Disabilities at baseline, after 06 weeks and 12 weeks of intervention.

详细描述

Physical therapy is an important component of rehabilitation regimen which is commonly used in the management of children with CP. Massage is also used as a complimentary alternative medicine (CAM). It has many types being practiced across the globe. Traditional massage is a type of massage being practiced in a specific society and has its own way of execution. It does not need professional education, training and certification so do not have any financial burden on the caregivers. As Pakistan is a poor country with low socio-economic status, so such measures of management which involve less financial burden on caregivers need to be investigated.

In this RCT, traditional massage was performed on the participants in the supine lying position. Each upper and lower limb was massaged for five minutes with gentle rubbing in proximal to distal direction. Five minutes massage was also provided at front and back of trunk area each in center to periphery direction. This type of traditional massage is practiced in Pakistan population which is somewhat different to Swedish massage. In few previous studies effect of Swedish massage on spastic CP has been investigated with conflicting level of evidence. However no study has been conducted in Pakistan to see the effects of traditional massage on children with 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

outcome assessor was kept blind about group identification of the participants before assessments at baseline, after 06 weeks and 12 weeks of intervention.

入排标准

年龄范围
2 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Child should have diagnosis of spastic cerebral palsy (hemiplegic and diplegic types only).

排除标准

  • Children having moderate to severe contractures.
  • Children having moderate to severe mental retardation and with multiple disabilities.
  • Children with Attention Deficit Hyperactive Disorder (ADHD), uncontrolled seizures and behavioral disorders

研究组 & 干预措施

Control group

Active Comparator

Routine physical therapy

[Time Frame: Twelve weeks]

干预措施: Control group (Other)

Intervention group

Experimental

Traditional massage + Routine physical therapy

[Time Frame: Twelve weeks]

干预措施: Intervention Group (Other)

结局指标

主要结局

Modified Ashworth scale

时间窗: Twelve weeks

* 0 = No increase in muscle tone * 1 = Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension * 1+ = Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the Range Of Motion (ROM) * 2 = More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved * 3 = Considerable increase in muscle tone, passive movement difficult. * 4 = Affected part(s) rigid in flexion or extension

次要结局

  • Gross motor Function Measure(Twelve weeks)
  • CPCHILD ( Caregiver Priorities & child health index of life with Disabilities(Twelve weeks)
  • Gross Motor Function Classification System(Twelve weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Qamar Mehmood

Senior Physiotherapist & Head of Physiotherapy Department NIRM

Isra University

研究点 (2)

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