Teachers College, Columbia University Center for Cerebral Palsy Research
New York, 10027, United States
NCT Number: NCT02299284
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/
Looking for future studies?
Notify Me2 year–12 year
All sexes
Interventional
Not applicable
New York, 10027, United States
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?
Can I choose to receive upper or lower extremity training if my child qualifies?
What if my child does not qualify?
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Change from baseline to 9 weeks
measure of bimanual hand-use in spontaneous play setting
Time frame: Change from baseline to 9 weeks
measures child's velocity when walking over 10 meters
Time frame: Change from baseline to 6 months
measure of bimanual hand-use in spontaneous play setting
Time frame: Change from baseline to 6 months
measures child's velocity when walking over 10 meters
Teachers College, Columbia University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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