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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02299284
• Other study ID #: 13-219CR
• Status: Completed
• Phase: N/A
• First received: November 12, 2014
• Last updated: May 4, 2017
• Start date: June 2013
• Est. completion date: June 2015

Study information

• Verified date: May 2017
• Source: Teachers College, Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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/

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• Children that have received Botox or are planning any new treatment within 6 mos. of enrollment in the study.

Related Conditions & MeSH terms

• Cerebral Palsy
• Hemiplegia

Intervention

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

Locations

Country	Name	City	State
United States	Teachers College, Columbia University Center for Cerebral Palsy Research	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Teachers College, Columbia University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. Review. — View Citation

Ferre CL, Brandão 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assisting Hand Assessment	measure of bimanual hand-use in spontaneous play setting	Change from baseline to 9 weeks
Primary	10 Meter walk test	measures child's velocity when walking over 10 meters	Change from baseline to 9 weeks
Secondary	Assisting Hand Assessment	measure of bimanual hand-use in spontaneous play setting	Change from baseline to 6 months
Secondary	10 Meter walk test	measures child's velocity when walking over 10 meters	Change from baseline to 6 months