Intensive Home-based Bimanual and Lower-limb Training in Young Children With Hemiplegia
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy; Hemiplegia
Study type: Interventional

Summary: 
      A randomized control trial to test the efficacy of a new treatment involving intensive
      home-based bimanual training (Hand-Arm Bimanual Intensive Therapy (HABIT) and intensive
      home-based functional lower-limb training in children with hemiplegia. The protocols have
      been developed at TC Columbia University to be child friendly and draw upon the investigators
      experience since 1998 with intensive movement therapy in children with cerebral palsy. The
      aim is to promote either the use/coordination of movement of the hands or improve lower-limb
      balance, strength, and function. Caregivers will be trained at the investigator center and
      then be asked to do 2 hours per day, 5 days per week, for 9 weeks (90 hours total) of
      activities with their child in their own home. The activities will be supervised by the
      investigators team via computer. Participants do NOT need to live in the New York City area,
      but a one-time weekend visit to the investigators center is required for training. All
      measurement and treatment is performed in the home.

      Participants are randomized to receive either HABIT or lower-limb training. If caregivers
      wish, they may chose to be crossed over at the end of the study and trained to receive the
      other treatment. PARTICIPATION IS FREE. Please check out the investigators website for more
      information: http://www.tc.edu/centers/cit/
    

Detailed description: 
      The investigators are currently recruiting children with hemiplegia between the ages of 2.5
      to 12 years of age to participate in a study examining the effects of extensive practice on
      affected hand/arm use and lower- limb use. This is a research study that will teach
      caregivers how to administer either hand-arm bimanual intensive training (HABIT) or
      lower-limb intensive training in their own home. HABIT aims to improve the use and
      coordination of both arms in daily function, particularly during the performance of bimanual
      activities (i.e. buttoning a shirt, cutting with scissors). Lower-limb intensive training
      aims to improve the quality of lower-limb functioning with a particular focus on functional
      activities (i.e. getting up from a chair, walking, climbing stairs).

      What does participation entail?

        -  Being randomized to learn to provide either intensive lower- or upper-limb activities in
           your own home (training will be provided over a a weekend session at our center)

        -  Getting trained to administer some basic upper- and lower-limb assessments in your own
           home

        -  Completing 90 hours of activities over a period of 9 weeks (2 hrs/day, 5 days/week; does
           not have to be 2 consecutive hours for daily activities)

        -  Videoconferencing online with a project supervisor at least 1 hour per week during
           activities

        -  Learning how to assess your child's motor function for posttesting.

      Can I choose to receive upper or lower extremity training if my child qualifies?

      • Unfortunately not, it must be randomly assigned as each group will be compared to the
      other. However, the investigators can provide training tips after completion of the study.

      What if my child does not qualify?

        -  There may be opportunities at a later date or for another study.

        -  Please contact us at (212)-678-3332 or cpresearch@tc.columbia.edu if you have any
           questions.
    

Intervention name(s): Intensive Home-based Bimanual and Lower-limb Training in Young Children With Hemiplegia
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Spastic; Hemiplegia