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

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ClinicalTrials.gov Identifier: NCT03771599
Recruitment Status : Unknown
Verified December 2018 by Qamar Mehmood, Isra University.
Recruitment status was:  Recruiting
First Posted : December 11, 2018
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
Qamar Mehmood, Isra University

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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy, Spastic, Diplegic Other: Intervention Group Other: Control group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: Single (Outcomes Assessor)
Masking Description: outcome assessor was kept blind about group identification of the participants before assessments at baseline, after 06 weeks and 12 weeks of intervention.
Primary Purpose: Treatment
Official Title: The Effects of Traditional Massage on Spasticity and Activity of Children(2 to 10 Years) With Cerebral Palsy
Actual Study Start Date : September 1, 2016
Estimated Primary Completion Date : January 30, 2019
Estimated Study Completion Date : February 15, 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Routine physical therapy and Traditional massage




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)

  2. 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

  3. 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.



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Ages Eligible for Study:   2 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03771599


Contacts
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Contact: Qamar Mehmood, PHD* +923335151063 qamarpt@yahoo.com

Locations
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Pakistan
Isra University Recruiting
Islamabad, Federal, Pakistan, 44000
Contact: Qamar Mehmood, PHD*    +923335151063    qamarpt@yahoo.com   
Sponsors and Collaborators
Isra University
Publications:

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Responsible Party: Qamar Mehmood, Senior Physiotherapist & Head of Physiotherapy Department NIRM, Isra University
ClinicalTrials.gov Identifier: NCT03771599    
Other Study ID Numbers: IIRS-IUISB/PHD/002
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Qamar Mehmood, Isra University:
cerebral palsy, traditional massage, spasticity, children
Additional relevant MeSH terms:
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Muscle Spasticity
Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations