Therapeutic Potential of Myofascial Structural Integration in Children With Cerebral Palsy

Not Applicable

Completed

• Conditions: Spastic Cerebral Palsy
• Interventions: Other: Rolfing / Myofascial Structural Integration

• Registration Number: NCT01815814
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2013-03-19
• Study First Submitted QC: 2013-03-19
• Study First Posted: 2013-03-21
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2015-05
• Last Update Submitted: 2015-07-04
• Last Update Posted: 2015-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rolfing After 3-Month Wait	Rolfing / Myofascial Structural Integration	The children in this arm receive the therapy (rolfing / myofascial structural integration) 3 months after they start the study.
Rolfing After 6-Month Wait	Rolfing / Myofascial Structural Integration	The children in this arm receive the therapy (rolfing / myofascial structural integration) 6 months after they start the study.

Primary Outcome Measures

Name	Time	Method
Change in Gross Motor Function Measure Score	at Enrollment and every 3 months thereafter for up to 12 months

Secondary Outcome Measures

Name	Time	Method
Change in GAITRite Mat Measures	at Enrollment and every 3 months thereafter for up to 12 months

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States