NCT01815814
Completed
Not Applicable
Therapeutic Potential of Myofascial Structural Integration in Children With Cerebral Palsy
ConditionsSpastic Cerebral Palsy
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Stanford University
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Change in Gross Motor Function Measure Score
Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 1 Year to 3 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Change in Gross Motor Function Measure Score
Time Frame: at Enrollment and every 3 months thereafter for up to 12 months
Secondary Outcomes
- Change in GAITRite Mat Measures(at Enrollment and every 3 months thereafter for up to 12 months)
Investigators
Heidi M. Feldman
Ballinger-Swindells Professor of Developmental and Behavioral Pediatrics
Stanford University
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 2
Does Reducing Spasticity Permit an Increase in Strength?Spastic Diplegic Cerebral PalsyNCT00255073University of Southern California10
Completed
Not Applicable
Myofascial Stretch With And Without Functional Massage In Children With Cerebral PalsyCerebral Palsy, Functional Massage, Myofacial StretchNCT05392335Riphah International University22
Completed
Not Applicable
Photo Biostimulation and Spasticity in Cerebral PalsyCerebral PalsyCerebral Palsy, SpasticNCT05912959University of Hail54
Completed
Not Applicable
Comparative Effects of Myofascial Stretch and Contract-relax in Children With Spastic cpCerebral PalsyNCT06292507Riphah International University22
Completed
Not Applicable
Muscle Spasticity Reduction in Children With Cerebral Palsy by Means of HippotherapyNeuromuscular Diseases in ChildrenCerebral Palsy, SpasticSpasticity, MuscleNCT03212846University of Cadiz50