Therapeutic Potential of Myofascial Structural Integration in Children With Cerebral Palsy

Spastic Cerebral Palsy Clinical Trial

Official title:

Therapeutic Potential of Myofascial Structural Integration in Children With Cerebral Palsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01815814
• Other study ID #: 104644
• Secondary ID: 16807
• Status: Completed
• Phase: N/A
• First received: March 19, 2013
• Last updated: July 4, 2015
• Start date: November 2011
• Est. completion date: November 2014

Study information

• Verified date: May 2015
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 3 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy
• Spastic Cerebral Palsy

Intervention

Other:
• Rolfing / Myofascial Structural Integration
Rolfing is similar to deep massage. It is also known as "myofascial structural integration."

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	The Gerber Foundation

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Gross Motor Function Measure Score		at Enrollment and every 3 months thereafter for up to 12 months	No
Secondary	Change in GAITRite Mat Measures		at Enrollment and every 3 months thereafter for up to 12 months	No

External Links

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