Therapeutic Potential of Myofascial Structural Integration in Children With Cerebral Palsy

This study is ongoing, but not recruiting participants.
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: August 2, 2014
Last verified: August 2014
  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 Study Completion Date: August 2015
Estimated Primary Completion Date: August 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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: August 2, 2014
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 August 26, 2014