The Effects of Traditional Massage on Spasticity and Activity of Children(2 to 10 Years) With Cerebral Palsy
Primary Purpose
Cerebral Palsy, Spastic, Diplegic
Status
Unknown status
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Intervention Group
Control group
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy, Spastic, Diplegic focused on measuring cerebral palsy, traditional massage, spasticity, children
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
Sites / Locations
- Isra UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control group
Intervention group
Arm Description
Routine physical therapy [Time Frame: Twelve weeks]
Traditional massage + Routine physical therapy [Time Frame: Twelve weeks]
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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)
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03771599
Brief Title
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
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2016 (Actual)
Primary Completion Date
January 30, 2019 (Anticipated)
Study Completion Date
February 15, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isra University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Spastic, Diplegic
Keywords
cerebral palsy, traditional massage, spasticity, children
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
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.
Allocation
Randomized
Enrollment
86 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Routine physical therapy
[Time Frame: Twelve weeks]
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Traditional massage + Routine physical therapy
[Time Frame: Twelve weeks]
Intervention Type
Other
Intervention Name(s)
Intervention Group
Other Intervention Name(s)
Routine physical therapy and Traditional massage
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control group
Other Intervention Name(s)
Routine Physical Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Modified Ashworth scale
Description
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
Time Frame
Twelve weeks
Secondary Outcome Measure Information:
Title
Gross motor Function Measure
Description
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)
Time Frame
Twelve weeks
Title
Gross Motor Function Classification System
Description
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
Time Frame
Twelve weeks
Title
CPCHILD ( Caregiver Priorities & child health index of life with Disabilities
Description
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.
Time Frame
Twelve weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qamar Mehmood, PHD*
Phone
+923335151063
Email
qamarpt@yahoo.com
Facility Information:
Facility Name
Isra University
City
Islamabad
State/Province
Federal
ZIP/Postal Code
44000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qamar Mehmood, PHD*
Phone
+923335151063
Email
qamarpt@yahoo.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
12600249
Citation
Reddihough DS, Collins KJ. The epidemiology and causes of cerebral palsy. Aust J Physiother. 2003;49(1):7-12. doi: 10.1016/s0004-9514(14)60183-5.
Results Reference
background
PubMed Identifier
21273041
Citation
Kirby RS, Wingate MS, Van Naarden Braun K, Doernberg NS, Arneson CL, Benedict RE, Mulvihill B, Durkin MS, Fitzgerald RT, Maenner MJ, Patz JA, Yeargin-Allsopp M. Prevalence and functioning of children with cerebral palsy in four areas of the United States in 2006: a report from the Autism and Developmental Disabilities Monitoring Network. Res Dev Disabil. 2011 Mar-Apr;32(2):462-9. doi: 10.1016/j.ridd.2010.12.042. Epub 2011 Jan 26.
Results Reference
background
PubMed Identifier
16437058
Citation
Bhasin TK, Brocksen S, Avchen RN, Van Naarden Braun K. Prevalence of four developmental disabilities among children aged 8 years--Metropolitan Atlanta Developmental Disabilities Surveillance Program, 1996 and 2000. MMWR Surveill Summ. 2006 Jan 27;55(1):1-9. Erratum In: MMWR Morb Mortal Wkly Rep. 2006 Feb 3;55(4):105-6.
Results Reference
background
PubMed Identifier
17370477
Citation
Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14. Erratum In: Dev Med Child Neurol. 2007 Jun;49(6):480.
Results Reference
background
PubMed Identifier
16765723
Citation
Paneth N, Hong T, Korzeniewski S. The descriptive epidemiology of cerebral palsy. Clin Perinatol. 2006 Jun;33(2):251-67. doi: 10.1016/j.clp.2006.03.011.
Results Reference
background
PubMed Identifier
23672634
Citation
Reddihough DS, Jiang B, Lanigan A, Reid SM, Walstab JE, Davis E. Social outcomes of young adults with cerebral palsy. J Intellect Dev Disabil. 2013 Sep;38(3):215-22. doi: 10.3109/13668250.2013.788690. Epub 2013 May 14.
Results Reference
background
PubMed Identifier
2415788
Citation
Goodman M, Rothberg AD, Houston-McMillan JE, Cooper PA, Cartwright JD, van der Velde MA. Effect of early neurodevelopmental therapy in normal and at-risk survivors of neonatal intensive care. Lancet. 1985 Dec 14;2(8468):1327-30. doi: 10.1016/s0140-6736(85)92626-1.
Results Reference
background
PubMed Identifier
12785436
Citation
Hurvitz EA, Leonard C, Ayyangar R, Nelson VS. Complementary and alternative medicine use in families of children with cerebral palsy. Dev Med Child Neurol. 2003 Jun;45(6):364-70. doi: 10.1017/s0012162203000707.
Results Reference
background
PubMed Identifier
23962350
Citation
Novak I, McIntyre S, Morgan C, Campbell L, Dark L, Morton N, Stumbles E, Wilson SA, Goldsmith S. A systematic review of interventions for children with cerebral palsy: state of the evidence. Dev Med Child Neurol. 2013 Oct;55(10):885-910. doi: 10.1111/dmcn.12246. Epub 2013 Aug 21.
Results Reference
background
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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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