Clinical trial NCT01815814: 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
Overall status: COMPLETED
Phase: NA
Conditions: Spastic Cerebral Palsy
Keywords: spasticity
cerebral palsy
hemiplegia
hemiparesis
diplegia
paraplegia
quadriplegia
quadriparesis
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: The Gerber Foundation
First posted: 2013-03-21
Enrollment: 38
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Gross Motor Function Measure Score
timeFrame: at Enrollment and every 3 months thereafter for up to 12 months
Secondary outcomes:
measure: Change in GAITRite Mat Measures
timeFrame: at Enrollment and every 3 months thereafter for up to 12 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Heidi M Feldman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.