Therapeutic Potential of Myofascial Structural Integration in Children With Cerebral Palsy

NCT ID: NCT01815814

Last Updated: 2015-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2014-11-30

Brief Summary

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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

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* 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.

Conditions

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Spastic Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Rolfing After 3-Month Wait

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

Group Type EXPERIMENTAL

Rolfing / Myofascial Structural Integration

Intervention Type OTHER

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.

Group Type OTHER

Rolfing / Myofascial Structural Integration

Intervention Type OTHER

Rolfing is similar to deep massage. It is also known as "myofascial structural integration."

Interventions

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Rolfing / Myofascial Structural Integration

Rolfing is similar to deep massage. It is also known as "myofascial structural integration."

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Gerber Foundation

OTHER

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Heidi M. Feldman

Ballinger-Swindells Professor of Developmental and Behavioral Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Heidi M Feldman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

References

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Hansen AB, Price KS, Loi EC, Buysse CA, Jaramillo TM, Pico EL, Feldman HM. Gait changes following myofascial structural integration (Rolfing) observed in 2 children with cerebral palsy. J Evid Based Complementary Altern Med. 2014 Oct;19(4):297-300. doi: 10.1177/2156587214540466. Epub 2014 Jul 2.

Reference Type BACKGROUND
PMID: 24989994 (View on PubMed)

Related Links

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http://dbpresearch.stanford.edu

Click here for more information about this study

Other Identifiers

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16807

Identifier Type: OTHER

Identifier Source: secondary_id

104644

Identifier Type: -

Identifier Source: org_study_id

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