Clinical Research Studies > apples research study: a soft constraint parent-directed therapy for infants and toddlers 9-27 months
APPLES Research Study: A Soft Constraint Parent-Directed Therapy for Infants and Toddlers 9-27 Months
The APPLES Study: APositive Parent-focused training for upper Limb Experience with Sensory-motor feedback
What is the purpose of this study?
The purpose of this study is to evaluate the effectiveness of a soft mitt constraint on a weaker hand and parent-directed interactions on arm function for young children with hemiplegic cerebral palsy (CP).
Infants and young toddlers in this study will use a non-invasive, soft mitt for Constraint Induced Movement Therapy (CIMT), a therapy that is well-tested in older children with CP, along with specific games and activities.
Image: APPLES Study constraint participant crawling in a session with Helen Carey, PT, DHSc, PCS
Some of the participants in this study will have CP, while others will not have motor difficulties.
The study team will test how well a soft mitt used on the more affected hand, along with therapeutic activities taught by physicial therapists (from Nationwide Children's Hospital and The Ohio State University) may help improve motor function for participants with CP.
Children enrolled in this study that do not have CP will only participate in assessment visits and will not use the soft mitt.
Who can participate in this study?
Infants and toddlers between the ages of 9-27 months at the time of enrollment are eligible for this study, after signed parental consent has been completed.
Ages 9 to 27 months at the start of the study
Infants with cerebral palsy who have one side of their body stronger than the other
Infants without cerebral palsy and no other motor difficulties to participate as controls
Caregivers must be willing to have their child with cerebral palsy wear a soft mitt for six (6) hours at a time and provide two (2) daily at-home sessions lasting 15 minutes each. After the mitt is taken off, caregivers will need to play with their child using two-handed toys as much as possible. Training and support by therapists, as well as materials for activities, will be provided to caregivers.
Caregivers must also be willing to come to Nationwide Children's Hospital for assessments, and transportation will be arranged as needed.
What will happen during this study?
There will be several visits during this study:
Participants with cerebral palsy will have assessment and training visits.
Participants without motor difficulties will only have assessment visits.
Assessment appointments will take between 45-60 minutes. During the appointment, research therapists will assess your child using standard movement assessments. A test called "Event-Related Potential (ERP)" will also be performed to measure natural brain electricity and record your infant's brain waves, using soft sensors placed on your child's head with a net, like a shower cap.
At the end of the first assessment visit, therapists will teach caregivers of participants with CP how to do activities at home using the mitts and supplies that we provide.
This study is randomized. This means that young infants and toddlers with CP will be randomly assigned to one of two groups:
For children with CP, participants in both groups will receive the soft mitt constraint intervention.
The difference between the two groups will be the timing of the start of these additional therapy services.
Your child will continue their regular therapy visits regardless of his/her group study assignment and regardless of his/her participation in the study.
In addition to providing materials to caregivers, we will also compensate you for your time.