Therapeutic Potential of Myofascial Structural Integration in Children With Cerebral Palsy

July 4, 2015 updated by: Heidi M. Feldman, Stanford University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 3 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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."
OTHER: 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."

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Gross Motor Function Measure Score
Time Frame: at Enrollment and every 3 months thereafter for up to 12 months
at Enrollment and every 3 months thereafter for up to 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in GAITRite Mat Measures
Time Frame: at Enrollment and every 3 months thereafter for up to 12 months
at Enrollment and every 3 months thereafter for up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

The Gerber Foundation

Investigators

  • Principal Investigator: Heidi M Feldman, MD, PhD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (ACTUAL)

November 1, 2014

Study Completion (ACTUAL)

November 1, 2014

Study Registration Dates

First Submitted

March 19, 2013

First Submitted That Met QC Criteria

March 19, 2013

First Posted (ESTIMATE)

March 21, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

July 8, 2015

Last Update Submitted That Met QC Criteria

July 4, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 104644
  • 16807 (OTHER: Stanford University)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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