Therapeutic Potential of Myofascial Structural Integration in Children With Cerebral Palsy (NCT01815814) | Clinical Trial Compass
CompletedNot Applicable
Therapeutic Potential of Myofascial Structural Integration in Children With Cerebral Palsy
United States38 participantsStarted 2011-11
Plain-language 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.
Who can participate
Age range
1 Year – 3 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Gross Motor Function Measure Score
Timeframe: at Enrollment and every 3 months thereafter for up to 12 months