NCT01815814

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 21, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

July 8, 2015

Status Verified

May 1, 2015

Enrollment Period

3 years

First QC Date

March 19, 2013

Last Update Submit

July 4, 2015

Conditions

Spastic Cerebral Palsy

Keywords

spasticitycerebral palsyhemiplegiahemiparesisdiplegiaparaplegiaquadriplegiaquadriparesis

Outcome Measures

Primary Outcomes (1)

  • Change in Gross Motor Function Measure Score

    at Enrollment and every 3 months thereafter for up to 12 months

Secondary Outcomes (1)

  • Change in GAITRite Mat Measures

    at Enrollment and every 3 months thereafter for up to 12 months

Study Arms (2)

Rolfing After 3-Month Wait

EXPERIMENTAL

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 After 6-Month Wait

OTHER

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

Other: Rolfing / Myofascial Structural Integration

Interventions

Rolfing / Myofascial Structural IntegrationOTHER

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

Rolfing After 3-Month WaitRolfing After 6-Month Wait

Eligibility Criteria

Age1 Year - 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

  • 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.

    PMID: 24989994BACKGROUND

Related Links

MeSH Terms

Conditions

Cerebral PalsyMuscle SpasticityHemiplegiaParesisParaplegiaQuadriplegia

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsParalysis

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Heidi M Feldman, MD, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ballinger-Swindells Professor of Developmental and Behavioral Pediatrics

Study Record Dates

First Submitted

March 19, 2013

First Posted

March 21, 2013

Study Start

November 1, 2011

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

July 8, 2015

Record last verified: 2015-05

Locations

US(1)