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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Cerebral Palsy, Spastic, Diplegic

Intervention / Treatment
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* Other: Intervention Group
* Other: Control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Child should have diagnosis of spastic cerebral palsy (hemiplegic and diplegic types only). Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: It is a RCT with two groups, control and intervention. Both groups received routine physical therapy five days a week for a period of three months. Intervention group also received traditional massage for thirty minutes before start of the routine physical therapy. Data was collected at baseline, after 06 weeks and 12 weeks of intervention
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>Routine physical therapy [Time Frame: Twelve weeks] | Other: Control group<br>* Routine physical therapy comprising stretching of tight muscles ( stretch each muscle for five times with hold time of twenty seconds), Strengthening of weak muscles (perform resisted exercises ten times for each weak muscle), positioning ( how to make sitting and standing postures at home). This whole regimen was to be practiced fives times a week for a period of twelve weeks.<br>* Other names: Routine Physical Therapy;|
| Experimental: Intervention group<br>Traditional massage + Routine physical therapy [Time Frame: Twelve weeks] | Other: Intervention Group<br>* Traditional massage of thirty minutes duration ( five minutes of massage was provided to all four limbs, front and back of trunk area) prior to routine physical therapy. Routine physical therapy comprising stretching of tight muscles ( stretch each muscle for five times with hold time of twenty seconds), Strengthening of weak muscles (perform resisted exercises ten times for each weak muscle), positioning ( how to make sitting and standing postures at home). This whole regimen was to be practiced fives times a week for a period of twelve weeks.<br>* Other names: Routine physical therapy and Traditional massage;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Ashworth scale | 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 | Twelve weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gross motor Function Measure | to see the gross motor ability having total of 88 items to be checked in 05 different domain Lying and Rolling (total score 51), Sitting (Total score 60), Crawling and Kneeling( total 42), standing (total 39), walking running jumping (total 72) | Twelve weeks | 
| Gross Motor Function Classification System | It has five levels I to V showing the mobility level. Level I to III represent ambulatory status while IV and V represent Non- ambulatory status | Twelve weeks | 
| CPCHILD ( Caregiver Priorities & child health index of life with Disabilities | to see the quality of life of children with cerebral palsy. It has 09 sections to be completed representing different states related to quality of life. | Twelve weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cerebral palsy, traditional massage, spasticity, children