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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/
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?
• 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?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hand-Arm Bimanual Intensive Therapy (HABIT) | Experimental | HABIT, bimanual training, bilateral training, restraint therapy, PT, OT, rehab |
|
| Intensive Functional Lower-Limb Training | Experimental | lower-limb function, strength training, balance, PT, OT, rehab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive Home-based Bimanual and Lower-limb Training in Young Children With Hemiplegia | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assisting Hand Assessment | measure of bimanual hand-use in spontaneous play setting | Change from baseline to 9 weeks |
| 10 Meter walk test | measures child's velocity when walking over 10 meters | Change from baseline to 9 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Assisting Hand Assessment | measure of bimanual hand-use in spontaneous play setting | Change from baseline to 6 months |
| 10 Meter walk test | measures child's velocity when walking over 10 meters |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Gordon, Ph.D. | Teachers College, Columbia University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teachers College, Columbia University Center for Cerebral Palsy Research | New York | New York | 10027 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17044964 | Background | Charles J, Gordon AM. Development of hand-arm bimanual intensive training (HABIT) for improving bimanual coordination in children with hemiplegic cerebral palsy. Dev Med Child Neurol. 2006 Nov;48(11):931-6. doi: 10.1017/S0012162206002039. | |
| 25180530 | Result | Ferre CL, Brandao MB, Hung YC, Carmel JB, Gordon AM. Feasibility of caregiver-directed home-based hand-arm bimanual intensive training: a brief report. Dev Neurorehabil. 2015 Feb;18(1):69-74. doi: 10.3109/17518423.2014.948641. Epub 2014 Sep 2. |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| D009128 | Muscle Spasticity |
| D006429 | Hemiplegia |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Change from baseline to 6 months |
| 17979861 | Result | Gordon AM, Schneider JA, Chinnan A, Charles JR. Efficacy of a hand-arm bimanual intensive therapy (HABIT) in children with hemiplegic cerebral palsy: a randomized control trial. Dev Med Child Neurol. 2007 Nov;49(11):830-8. doi: 10.1111/j.1469-8749.2007.00830.x. |
| 31434537 | Derived | Surana BK, Ferre CL, Dew AP, Brandao M, Gordon AM, Moreau NG. Effectiveness of Lower-Extremity Functional Training (LIFT) in Young Children With Unilateral Spastic Cerebral Palsy: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2019 Oct;33(10):862-872. doi: 10.1177/1545968319868719. Epub 2019 Aug 22. |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010243 | Paralysis |