Offered by: Nemours
Location: Orlando, Fla.
What is the trial about?
This study is being done to determine if a more intense series of physical and occupational therapies is more effective in helping young children with cerebral palsy improve their motor function than is the current standard of care.
Who can participate?
Children, between the ages of 12 months and 36 months who have been diagnosed by a pediatric neurologist or rehabilitation specialist with spastic cerebral palsy with a level of severity of I, II or III based on the Gross Motor Functional Classification System and whose motor dysfunction occurred during pregnancy or within 1 year after birth, may participate in the study.
What is involved?
This study will last 48 weeks. The children enrolled will be randomly (like the toss of a coin) assigned to one of two groups. The children in Group 1 will have 5 visits each week for the first 12 weeks (intense phase) at Nemours Children’s Hospital in Orlando. These visits will consist of 30 minutes of physical therapy and 30 minutes of occupational therapy. Then for the next 36 weeks the children in this group will have one visit each week (standard of care phase) at the same department, and will receive 30 minutes of physical therapy (PT) and 30 minutes of occupational therapy (OT). One visit per week is the standard number of visits children with cerebral palsy normally receive.
The schedule for the children in Group 2 will be reversed. That is, for the first 36 weeks they will receive the two therapies one time each week and for the remaining 12 weeks they will receive the therapies 5 times each week.
In addition to the PT and OT visits, there will be 5 gross motor function evaluations (ability to move and coordinate large muscle groups) using a standard test especially designed for children with cerebral palsy (GMFM-66). These evaluations will be done by your child's treating physical therapist. It will be recorded on video using 2 cameras mounted on 2 different walls to catch your child’s response to the tasks requested by the therapist. The de-identified recording will be downloaded onto a password protected web site. These videos will be scored by another therapist who is unaware of which group your child is in. You will be asked to complete a questionnaire (PEDI) that describes what level you feel your child is at. These evaluations will be repeated 5 times during the course of the 48 weeks: at the beginning of therapies, at the end of the first 12 weeks, after 24 weeks, after 36 weeks and at the end of the study at 48 weeks.
Contact Nemours Clinical Trials
Trial Name: Intense Physiotherapies to Improve Function in Children With Cerebral Palsy