Clinical trial NCT03771599: The Effects of Traditional Massage on Spasticity and Activity of Children(2 to 10 Years) With Cerebral Palsy
Official title: The Effects of Traditional Massage on Spasticity and Activity of Children(2 to 10 Years) With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy, Spastic, Diplegic
Keywords: cerebral palsy, traditional massage, spasticity, children
Lead sponsor: Isra University
Sponsor class: OTHER
First posted: 2018-12-11
Enrollment: 86
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Modified Ashworth scale
timeFrame: Twelve weeks
Secondary outcomes:
measure: Gross motor Function Measure
timeFrame: Twelve weeks
measure: Gross Motor Function Classification System
timeFrame: Twelve weeks
measure: CPCHILD ( Caregiver Priorities & child health index of life with Disabilities
timeFrame: Twelve weeks
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Isra University
state: Federal
Study officials:
References:
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