Therapeutic Potential of Myofascial Structural Integration in Children With Cerebral Palsy

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

Study Description

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

• 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

Arms and Interventions

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

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

• 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

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:

Click here for more information about this study 

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
• Other Study ID Numbers: 104644; 16807 ( Other Identifier: Stanford University )
• First Posted: March 21, 2013
• 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; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases