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

December 11, 2018 updated by: Qamar Mehmood, Isra University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Federal
      • Islamabad, Federal, Pakistan, 44000
        • Recruiting
        • Isra University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group

Routine physical therapy

[Time Frame: Twelve weeks]
Other: Control group
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.
Other Names:
  • Routine Physical Therapy
Experimental: Intervention group

Traditional massage + Routine physical therapy

[Time Frame: Twelve weeks]
Other: Intervention Group

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.

Other Names:
  • Routine physical therapy and Traditional massage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Ashworth scale
Time Frame: 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
Twelve weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gross motor Function Measure
Time Frame: Twelve weeks
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
Time Frame: Twelve weeks
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
Time Frame: Twelve weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Isra University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Anticipated)

January 30, 2019

Study Completion (Anticipated)

February 15, 2019

Study Registration Dates

First Submitted

December 8, 2018

First Submitted That Met QC Criteria

December 8, 2018

First Posted (Actual)

December 11, 2018

Study Record Updates

Last Update Posted (Actual)

December 13, 2018

Last Update Submitted That Met QC Criteria

December 11, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIRS-IUISB/PHD/002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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