Intensive Home-based Bimanual and Lower-limb Training in Young Children With Hemiplegia

Cerebral Palsy Clinical Trial

Official title: Intensive Home-based Bimanual and Lower-limb Training in Young Children With Hemiplegia

Status Completed

Clinical Trial 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/

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Cerebral Palsy
• Hemiplegia

• NCT number: NCT02299284
• Study type: Interventional
• Source: Teachers College, Columbia University
• Status: Completed
• Phase: N/A
• Start date: June 2013
• Completion date: June 2015