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Therapeutic Potential of Myofascial Structural Integration in Children With Cerebral Palsy

Primary Purpose

Spastic Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Rolfing / Myofascial Structural Integration
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spastic Cerebral Palsy focused on measuring spasticity, cerebral palsy, hemiplegia, hemiparesis, diplegia, paraplegia, quadriplegia, quadriparesis

Eligibility Criteria

1 Year - 3 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Rolfing After 3-Month Wait

Rolfing After 6-Month Wait

Arm Description

The children in this arm receive the therapy (rolfing / myofascial structural integration) 3 months after they start the study.

The children in this arm receive the therapy (rolfing / myofascial structural integration) 6 months after they start the study.

Outcomes

Primary Outcome Measures

Change in Gross Motor Function Measure Score

Secondary Outcome Measures

Change in GAITRite Mat Measures

Full Information

First Posted
March 19, 2013
Last Updated
July 4, 2015
Sponsor
Stanford University
Collaborators
The Gerber Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01815814
Brief Title
Therapeutic Potential of Myofascial Structural Integration in Children With Cerebral Palsy
Official Title
Therapeutic Potential of Myofascial Structural Integration in Children With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
The Gerber Foundation

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spastic Cerebral Palsy
Keywords
spasticity, cerebral palsy, hemiplegia, hemiparesis, diplegia, paraplegia, quadriplegia, quadriparesis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rolfing After 3-Month Wait
Arm Type
Experimental
Arm Description
The children in this arm receive the therapy (rolfing / myofascial structural integration) 3 months after they start the study.
Arm Title
Rolfing After 6-Month Wait
Arm Type
Other
Arm Description
The children in this arm receive the therapy (rolfing / myofascial structural integration) 6 months after they start the study.
Intervention Type
Other
Intervention Name(s)
Rolfing / Myofascial Structural Integration
Intervention Description
Rolfing is similar to deep massage. It is also known as "myofascial structural integration."
Primary Outcome Measure Information:
Title
Change in Gross Motor Function Measure Score
Time Frame
at Enrollment and every 3 months thereafter for up to 12 months
Secondary Outcome Measure Information:
Title
Change in GAITRite Mat Measures
Time Frame
at Enrollment and every 3 months thereafter for up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heidi M Feldman, MD, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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
Results Reference
background
Links:
URL
http://dbpresearch.stanford.edu
Description
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Therapeutic Potential of Myofascial Structural Integration in Children With Cerebral Palsy

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