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OpenTrials
Completed

NCT Number: NCT01815814

Therapeutic Potential of Myofascial Structural Integration in Children With Cerebral Palsy

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.

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Key information

Conditions

Spastic Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Hemiplegia Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Paralysis Paraplegia Paresis Pathological Conditions, Signs and Symptoms Quadriplegia Signs and Symptoms

Age range

1 year–3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rolfing / Myofascial Structural Integration

Other

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

Primary outcomes

  1. Change in Gross Motor Function Measure Score

    Time frame: at Enrollment and every 3 months thereafter for up to 12 months

Secondary outcomes

  1. Change in GAITRite Mat Measures

    Time frame: at Enrollment and every 3 months thereafter for up to 12 months

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • The Gerber Foundation

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Mar 21, 2013
Registry last updated
Jul 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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