Therapeutic Potential of Myofascial Structural Integration in Children With Cerebral Palsy

This study is currently recruiting participants.
Verified July 2013 by Stanford University
Sponsor:
Collaborator:
The Gerber Foundation
Information provided by (Responsible Party):
Heidi M. Feldman, Stanford University
ClinicalTrials.gov Identifier:
NCT01815814
First received: March 19, 2013
Last updated: July 12, 2013
Last verified: July 2013
  Purpose

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 Intervention
Spastic Cerebral Palsy
Other: Rolfing / Myofascial Structural Integration

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Therapeutic Potential of Myofascial Structural Integration in Children With Cerebral Palsy

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Change from Baseline on the Gross Motor Function Measure at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline on the Gross Motor Function Measure at 9 months [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Change from Baseline on the Gross Motor Function Measure at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: November 2011
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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."

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.
  Eligibility

Ages Eligible for Study:   1 Year to 3 Years
Genders Eligible for Study:   Both
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)23 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01815814

Contacts
Contact: Elizabeth C Loi, BA (650) 498-7690 eloi@stanford.edu

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Principal Investigator: Heidi M Feldman, MD, PhD         
Sponsors and Collaborators
Stanford University
The Gerber Foundation
Investigators
Principal Investigator: Heidi M Feldman, MD, PhD Stanford University
  More Information

Additional Information:
No publications provided

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
Study First Received: March 19, 2013
Last Updated: July 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
spasticity
cerebral palsy
hemiplegia
hemiparesis
diplegia
paraplegia
quadriplegia
quadriparesis

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

ClinicalTrials.gov processed this record on April 16, 2014