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Therapeutic Potential of Myofascial Structural Integration in Children With Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT01815814
Recruitment Status : Completed
First Posted : March 21, 2013
Last Update Posted : July 8, 2015
Sponsor:
Collaborator:
The Gerber Foundation
Information provided by (Responsible Party):
Heidi M. Feldman, Stanford University

Study Description
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Brief Summary:

The investigators hypothesize that children with spastic cerebral palsy will show greater improvements in gross motor function, associated developmental skills and growth after the 3 months of myofascial structural integration treatment, a form of deep massage, than they showed after a 3- or 6-month pre-treatment waiting period.

The investigators further hypothesize that children with spastic CP will maintain their gains in gross motor function for ≥ 3 months after completion of MSI treatment.


Condition or disease Intervention/treatment Phase
Spastic Cerebral Palsy Other: Rolfing / Myofascial Structural Integration Not Applicable

Detailed Description:
  • The investigators will talk to you by telephone to determine if your child is eligible for the study.
  • The study lasts for a total of 12 months with the massage treatment period lasting 12 weeks.
  • The study entails a total of 10 sessions of Myofascial Structural Integration therapy over the 12-week period. Each session will last one hour.
  • The child will have an evaluation of motor functions and development on enrollment and at three-month intervals for a total of 5 evaluations.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Therapeutic Potential of Myofascial Structural Integration in Children With Cerebral Palsy
Study Start Date : November 2011
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Rolfing After 3-Month Wait
The children in this arm receive the therapy (rolfing / myofascial structural integration) 3 months after they start the study.
 Other: Rolfing / Myofascial Structural Integration
Rolfing is similar to deep massage. It is also known as "myofascial structural integration."
Rolfing After 6-Month Wait
The children in this arm receive the therapy (rolfing / myofascial structural integration) 6 months after they start the study.
 Other: Rolfing / Myofascial Structural Integration
Rolfing is similar to deep massage. It is also known as "myofascial structural integration."


Outcome Measures
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Primary Outcome Measures :
  1. Change in Gross Motor Function Measure Score [ Time Frame: at Enrollment and every 3 months thereafter for up to 12 months ]

Secondary Outcome Measures :
  1. Change in GAITRite Mat Measures [ Time Frame: at Enrollment and every 3 months thereafter for up to 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   1 Year to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children from 1 up to, but not including, 7 years of age
  • Children having the diagnosis of spastic cerebral palsy
  • Children who have spasticity in one or both upper or lower limbs
  • Children who are classified as either Gross Motor Function Classification System (GMFCS) level 2, 3 or 4 or Manual Ability Classification System (MACS) level 2, 3, 4 or 5

Exclusion Criteria:

  • Children with active seizure disorders
  • Children taking more than one medication to control their seizures
  • Children with severe health problems that could be exacerbated by the treatment (such as severe chronic lung disease)
  • Children who have undergone surgical treatments or botulinum injections within 6 months of entering the study
  • Children who have planned surgical interventions during the studies time course
  • Children with sensory, cognitive or language deficits which would affect their ability to understand directions necessary for assessment.
Contacts and Locations
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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): NCT01815814


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
The Gerber Foundation
Investigators
Principal Investigator: Heidi M Feldman, MD, PhD Stanford University
More Information
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Additional Information:
Click here for more information about this study  This link exits the ClinicalTrials.gov site

Publications:
Hansen AB, Price KS, Feldman HM. Myofascial structural integraton: A promising complementary therapy for young children with spastic cerebral palsy. Journal of Evidence-Based Complementary and Alternative Medicine 17: 131-135, 2012

Responsible Party: Heidi M. Feldman, Ballinger-Swindells Professor of Developmental and Behavioral Pediatrics, Stanford University
ClinicalTrials.gov Identifier: NCT01815814     History of Changes
Other Study ID Numbers: 104644
16807 ( Other Identifier: Stanford University )
First Posted: March 21, 2013    Key Record Dates
Last Update Posted: July 8, 2015
Last Verified: May 2015

Keywords provided by Heidi M. Feldman, Stanford University:
spasticity
cerebral palsy
hemiplegia
hemiparesis
 diplegia
paraplegia
quadriplegia
quadriparesis

Additional relevant MeSH terms:
Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
 Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases