Intensive Home-based Bimanual and Lower-limb Training in Young Children With Hemiplegia
Completed · Not applicable
Conditions studied: Cerebral Palsy
In brief
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/
Key facts
- Study ID
- NCT02299284
- Run by
- Teachers College, Columbia University
- People needed
- 24
- Starts
- 2013-06-01
- Expected to finish
- 2015-06-01
- Last updated by the study team
- 2017-05-09
Who can join
Age: 2 and older, up to 12. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Children between the ages of 2.5 - 12 years with hemiplegia; hemiplegia due to result of prenatal stroke, brain lesion, or malformation (or within the two years of life).
- Children that have the ability to grasp or release objects with the affected hand
- Children who are able to walk independently without the assistance of a device
- Children that have the cognitive capability to follow simple instructions and interact in play activities 2 hours per day with a parent/caregiver.
- Caregivers willing to commit to the entire intervention period of 90 hours over 9 weeks
- Caregivers able to provide one-on-one attention to child during the daily two hours of activities (note: because this is part of a research study, we can only train one caregiver per household)
You may not qualify if…
- Children that have received Botox or are planning any new treatment within 6 mos. of enrollment in the study.
Where it is running
- Teachers College, Columbia University Center for Cerebral Palsy Research — New York, New York, United States
Full record on ClinicalTrials.gov
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