Clinical Trial: Intensive Unimanual (CIMT) and Bimanual Training (HABIT) in Children With Hemiplegia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Intensive Unimanual (CIMT) and Bimanual Training (HABIT) in Children With Hemiplegia

Brief Summary: A randomized control trial examining the relationship between changes in hand function and brain plasticity following intensive therapy. Two treatment approaches are used: constraint-induced movement therapy (CIMT) or Hand-Arm Bimanual Intensive Therapy (HABIT). The protocols have been developed at TC Columbia University to be child friendly and draw upon our extensive experience with constraint-induced movement therapy in children with cerebral palsy. Our center has been providing interventions camps for children with cerebral palsy since 1998. The interventions are performed in a 15 day day-camp setting with several children and at least one interventionist per child. The aim of the intervention is to improve the use of the affected hand and quality of overall movement in a fun, social setting. PARTICIPATION IS FREE. Please check out our website for more information: http://www.tc.edu/centers/cit/

Detailed Summary:

Constraint-induced Movement Therapy and Bimanual training are motor-learning based approaches to engage children in fun activities. This study looks at what areas of the brain are responsible for recovery after intensive training. We are trying to understand how the brain responds to movement training and hope that in the future we can develop new treatments for hemiplegia based on what we learn about the brain in this study.

To study the areas of the brain we will use Magnetic Resonance Imaging (MRI) to take pictures of the brain and Transcranial Magnetic Stimulation (TMS) to determine parts of the brain involved in using the hand. TMS uses a brief magnetic field over the scalp by using a wand that looks like a figure 8. The wand can make brief magnetic fields over a series of spots on your child's head to activate the brain cells under the wand. Non-invasive, single pulse TMS will be used in this study, which is considered minimal risk and tolerable to children. If your child has a recurrent history of seizures after two years of age, he/she might not qualify.


Sponsor: Teachers College, Columbia University

Current Primary Outcome:

  • Jebsen-Taylor Test of Hand Function [ Time Frame: Change from baseline to immediately after intervention ]
  • Assisting Hand Assessment [ Time Frame: Change from baseline to immediately after intervention ]
  • Box and Blocks test [ Time Frame: Change from baseline to immediately after intervention ]


Original Primary Outcome: Same as current

Current Secondary Outcome: Canadian Occupational Performance Measure [ Time Frame: Change from baseline to immediately after intervention ]

Original Secondary Outcome: Same as current

Information By: Teachers College, Columbia University

Dates:
Date Received: September 27, 2016
Date Started: September 2014
Date Completion: December 31, 2020
Last Updated: May 4, 2017
Last Verified: May 2017