Stimulation for Perinatal Stroke – Optimizing Recovery Trajectories (SPORT)

Clinical Trials


Summary

Many children with hemiplegic cerebral palsy (CP) have weakness and motor difficulties when using their hemiplegic hand.  We aim to find new ways to improve the hand function for kids with hemiplegic CP. We know from research that Constraint Induced Movement Therapy (CIMT) camps promote use of the hand by limiting the use of the stronger hand by wearing a cast/splint combined with exercises of the hemiplegic hand.  In this research study, we are running a 2-week summer CIMT camp, where we will be exploring whether Transcranial Direct Current Stimulation (tDCS) helps to improve hand function when done in combination with CIMT. tDCS is a device that delivers a safe and very low level of electricity across the surface of the brain. We will also be taking pictures of the brain, to see what changes may happen in the brain when you do CIMT and tDCS.


Researcher(s)

Darcy Fehlings, MDDeryk Beal, PhD, Reg. CASLPO, CCC-SLP, Dr. Adam Kirton (University of Calgary), Dr. Nomazula Dlamini (Hospital for Sick Children, Toronto, ON), Dr. John Anderson (University of Alberta)


Participate in this study

Do you have a child or youth with hemiplegic cerebral palsy (CP)? Would they be interested in participating in a CIMT camp this summer with other kids to help work on moving and using their hemiplegic hand? If so, consider joining this study!


Who can participate

We are looking for children and youth with hemiplegic CP who are:

  • Age 6-18 years old
  • Able to lift their hemiplegic hand above a table and hold onto light objects
  • Do not have any metal in their body, including braces, any metal rods, plates, screws, nails, wire or an electronic implant or device
  • Will not receive:  Orthopedic surgery, constraint therapies, brain stimulation or other types of constraint therapies 6 months prior to the camp, or Botox 4 months prior to the camp

There are a few other things that we need to look for in people interested in participating in this study. If your child is interested, the research coordinator will ask you some more questions to see if this study is an option for your child. 


What's Involved

The study will take place at Holland Bloorview Kids Rehabilitation Hospital and the Hospital for Sick Children in Toronto. This study is a summer camp that uses constraint induced movement or CIMT for short. It includes therapy directed at improving the strength, use and control of your child’s affected hand. There will be 16 kids taking part in the study at Holland Bloorview over the course of two years (2018 and 2019). Eight individuals will take part in the summer of 2018 and another 8 will take part in the summer of 2019. Participants will also have a 50/50 chance of receiving tDCS or a pretend sham version during the CIMT camp. tDCS works by wearing a headband with wires attached to a machine. The headband gives a small amount of electricity (or stimulation) on the head. The tDCS brain stimulation is safe and does not hurt.

Before the camp, participants will come to Holland Bloorview to complete a few tests and activities with a research occupational therapist (OT), who will assess your child’s arm and hand movement and function. This will take about 3-4 hours to complete. Your child will also be given an activity motion watch to wear and will be required to wear the watch for the full 2 weeks of the camp. This watch will monitor all of the activities your child does with their arms and hands. Participants will also need to answer some questions about their motor function goals, how they are feeling and what kind of activities they do at home and school. This will take about 30 minutes to complete. Additionally, your child will have pictures of their brain taken at the Hospital for Sick Children that will take about 1 hour to complete.

During the camp, your child will come to Holland Bloorview each weekday for the summer camp. The camp activities will run from 9am - 4pm each day. The camp will be led by a team of research OTs. During week 1 of the camp, your child will wear a removable soft cast on their dominant arm, for most of the day and will receive one-on-one CIMT motor learning therapy. During week 2 of the camp, your child will receive one-on-one bimanual therapy. The real or sham tDCS will be applied every day of the camp for 30 minutes.

At the end of the camp, your child will answer a short questionnaire on their overall experience of the camp. This will take about 10-15 minutes to complete. Also, your child will return to Holland Bloorview 3 more times to repeat the tests and activities with the research OT that were done before the camp. Furthermore, participants will wear the motion watches for 48 hours in the week following CIMT camp, 2 months after CIMT camp, and 6-months after CIMT camp. Participants will also visit the Hospital for Sick Children 1 week after the camp and 6 months after the camp, to repeat the brain imaging (about 1 hour long), to see if there have been any changes overtime with their brain.


Deadline

May 2019 for the 2019 summer camp.


Interested in participating

If your child is interested in participating in this study or you have additional questions, please contact the study coordinator Daniel Warner at 416-425-6220 ext. 6482 or dwarner@hollandbloorview.ca. Contacting us does not obligate you or your child to participate in the study.


Funding Agency

CHILD-BRIGHT – funded by the Canadian Institutes of Health Research (CIHR)

Learn more about this study