<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03771599</url>
  </required_header>
  <id_info>
    <org_study_id>IIRS-IUISB/PHD/002</org_study_id>
    <nct_id>NCT03771599</nct_id>
  </id_info>
  <brief_title>The Effects of Traditional Massage on Spasticity and Activity of Children(2 to 10 Years) With Cerebral Palsy</brief_title>
  <official_title>The Effects of Traditional Massage on Spasticity and Activity of Children(2 to 10 Years) With Cerebral Palsy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Isra University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Isra University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study has been conducted to see the effects of traditional massage on spasticity and&#xD;
      activity of children with cerebral palsy (CP). It is a randomized controlled trial having two&#xD;
      groups, control and intervention. Both groups received routine physical therapy treatment&#xD;
      comprising stretching of tight muscles, strengthening of weak muscles, positioning and&#xD;
      handling. Intervention group also received traditional massage in addition to routine&#xD;
      physical therapy. Caregivers were trained to perform routine physical therapy treatment and&#xD;
      traditional massage at home. Data was collected using a structured questionnaire, Modified&#xD;
      Ashworth Scale (MAS), Gross Motor Function Classification System (GMFCS), Gross Motor&#xD;
      Function Measure (GMFM) and CPChild Caregiver Priorities &amp; Child Health Index of Life with&#xD;
      Disabilities at baseline, after 06 weeks and 12 weeks of intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Physical therapy is an important component of rehabilitation regimen which is commonly used&#xD;
      in the management of children with CP. Massage is also used as a complimentary alternative&#xD;
      medicine (CAM). It has many types being practiced across the globe. Traditional massage is a&#xD;
      type of massage being practiced in a specific society and has its own way of execution. It&#xD;
      does not need professional education, training and certification so do not have any financial&#xD;
      burden on the caregivers. As Pakistan is a poor country with low socio-economic status, so&#xD;
      such measures of management which involve less financial burden on caregivers need to be&#xD;
      investigated.&#xD;
&#xD;
      In this RCT, traditional massage was performed on the participants in the supine lying&#xD;
      position. Each upper and lower limb was massaged for five minutes with gentle rubbing in&#xD;
      proximal to distal direction. Five minutes massage was also provided at front and back of&#xD;
      trunk area each in center to periphery direction. This type of traditional massage is&#xD;
      practiced in Pakistan population which is somewhat different to Swedish massage. In few&#xD;
      previous studies effect of Swedish massage on spastic CP has been investigated with&#xD;
      conflicting level of evidence. However no study has been conducted in Pakistan to see the&#xD;
      effects of traditional massage on children with cerebral palsy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 1, 2016</start_date>
  <completion_date type="Anticipated">February 15, 2019</completion_date>
  <primary_completion_date type="Anticipated">January 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <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</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <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.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Modified Ashworth scale</measure>
    <time_frame>Twelve weeks</time_frame>
    <description>0 = No increase in muscle tone&#xD;
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&#xD;
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)&#xD;
2 = More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved&#xD;
3 = Considerable increase in muscle tone, passive movement difficult.&#xD;
4 = Affected part(s) rigid in flexion or extension</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gross motor Function Measure</measure>
    <time_frame>Twelve weeks</time_frame>
    <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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gross Motor Function Classification System</measure>
    <time_frame>Twelve weeks</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CPCHILD ( Caregiver Priorities &amp; child health index of life with Disabilities</measure>
    <time_frame>Twelve weeks</time_frame>
    <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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">86</enrollment>
  <condition>Cerebral Palsy, Spastic, Diplegic</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Routine physical therapy&#xD;
[Time Frame: Twelve weeks]</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Traditional massage + Routine physical therapy&#xD;
[Time Frame: Twelve weeks]</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Intervention Group</intervention_name>
    <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.&#xD;
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.</description>
    <arm_group_label>Intervention group</arm_group_label>
    <other_name>Routine physical therapy and Traditional massage</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control group</intervention_name>
    <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.</description>
    <arm_group_label>Control group</arm_group_label>
    <other_name>Routine Physical Therapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Child should have diagnosis of spastic cerebral palsy (hemiplegic and diplegic types&#xD;
             only).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children having moderate to severe contractures.&#xD;
&#xD;
          -  Children having moderate to severe mental retardation and with multiple disabilities.&#xD;
&#xD;
          -  Children with Attention Deficit Hyperactive Disorder (ADHD), uncontrolled seizures and&#xD;
             behavioral disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Qamar Mehmood, PHD*</last_name>
    <phone>+923335151063</phone>
    <email>qamarpt@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Isra University</name>
      <address>
        <city>Islamabad</city>
        <state>Federal</state>
        <zip>44000</zip>
        <country>Pakistan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Qamar Mehmood, PHD*</last_name>
      <phone>+923335151063</phone>
      <email>qamarpt@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>12600249</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>21273041</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>16437058</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>17370477</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>16765723</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>23672634</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>2415788</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>12785436</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>23962350</PMID>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 8, 2018</study_first_submitted>
  <study_first_submitted_qc>December 8, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>December 11, 2018</last_update_submitted>
  <last_update_submitted_qc>December 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 13, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Isra University</investigator_affiliation>
    <investigator_full_name>Qamar Mehmood</investigator_full_name>
    <investigator_title>Senior Physiotherapist &amp; Head of Physiotherapy Department NIRM</investigator_title>
  </responsible_party>
  <keyword>cerebral palsy, traditional massage, spasticity, children</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Spasticity</mesh_term>
    <mesh_term>Paralysis</mesh_term>
    <mesh_term>Cerebral Palsy</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03771599
org study id: IIRS-IUISB/PHD/002
nct id: NCT03771599
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
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
primary purpose: Treatment
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.
measure: Modified Ashworth scale
time frame: Twelve weeks
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
measure: Gross motor Function Measure
time frame: Twelve weeks
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)
measure: Gross Motor Function Classification System
time frame: Twelve weeks
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
measure: CPCHILD ( Caregiver Priorities & child health index of life with Disabilities
time frame: Twelve weeks
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.
arm group label: Control group
arm group type: Active Comparator
description: Routine physical therapy
[Time Frame: Twelve weeks]
arm group label: Intervention group
arm group type: Experimental
description: Traditional massage + Routine physical therapy
[Time Frame: Twelve weeks]
intervention type: Other
intervention name: Intervention Group
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.
arm group label: Intervention group
other name: Routine physical therapy and Traditional massage
intervention type: Other
intervention name: Control group
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.
arm group label: Control group
other name: Routine Physical Therapy
criteria: 
gender: All
minimum age: 2 Years
maximum age: 10 Years
healthy volunteers: No
last name: Qamar Mehmood, PHD*
phone: +923335151063
email: qamarpt@yahoo.com
facility: 
status: Recruiting
contact: 
country: Pakistan
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.
PMID: 12600249
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.
PMID: 21273041
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.
PMID: 16437058
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.
PMID: 17370477
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.
PMID: 16765723
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.
PMID: 23672634
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.
PMID: 2415788
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.
PMID: 12785436
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.
PMID: 23962350
responsible party type: Principal Investigator
investigator affiliation: Isra University
investigator full name: Qamar Mehmood
investigator title: Senior Physiotherapist & Head of Physiotherapy Department NIRM
mesh term: Muscle Spasticity
mesh term: Paralysis
mesh term: Cerebral Palsy