Intensive Home-based Bimanual and Lower-limb Training in Young Children With Hemiplegia
Primary Purpose
Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intensive Home-based Bimanual and Lower-limb Training in Young Children With Hemiplegia
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring Spastic, Hemiplegia
Eligibility Criteria
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.
Sites / Locations
- Teachers College, Columbia University Center for Cerebral Palsy Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Hand-Arm Bimanual Intensive Therapy (HABIT)
Intensive Functional Lower-Limb Training
Arm Description
HABIT, bimanual training, bilateral training, restraint therapy, PT, OT, rehab
lower-limb function, strength training, balance, PT, OT, rehab
Outcomes
Primary Outcome Measures
Assisting Hand Assessment
measure of bimanual hand-use in spontaneous play setting
10 Meter walk test
measures child's velocity when walking over 10 meters
Secondary Outcome Measures
Assisting Hand Assessment
measure of bimanual hand-use in spontaneous play setting
10 Meter walk test
measures child's velocity when walking over 10 meters
Full Information
NCT ID
NCT02299284
First Posted
November 12, 2014
Last Updated
May 4, 2017
Sponsor
Teachers College, Columbia University
1. Study Identification
Unique Protocol Identification Number
NCT02299284
Brief Title
Intensive Home-based Bimanual and Lower-limb Training in Young Children With Hemiplegia
Official Title
Intensive Home-based Bimanual and Lower-limb Training in Young Children With Hemiplegia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Teachers College, Columbia University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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/
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Spastic, Hemiplegia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hand-Arm Bimanual Intensive Therapy (HABIT)
Arm Type
Experimental
Arm Description
HABIT, bimanual training, bilateral training, restraint therapy, PT, OT, rehab
Arm Title
Intensive Functional Lower-Limb Training
Arm Type
Experimental
Arm Description
lower-limb function, strength training, balance, PT, OT, rehab
Intervention Type
Other
Intervention Name(s)
Intensive Home-based Bimanual and Lower-limb Training in Young Children With Hemiplegia
Primary Outcome Measure Information:
Title
Assisting Hand Assessment
Description
measure of bimanual hand-use in spontaneous play setting
Time Frame
Change from baseline to 9 weeks
Title
10 Meter walk test
Description
measures child's velocity when walking over 10 meters
Time Frame
Change from baseline to 9 weeks
Secondary Outcome Measure Information:
Title
Assisting Hand Assessment
Description
measure of bimanual hand-use in spontaneous play setting
Time Frame
Change from baseline to 6 months
Title
10 Meter walk test
Description
measures child's velocity when walking over 10 meters
Time Frame
Change from baseline to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Gordon, Ph.D.
Organizational Affiliation
Teachers College, Columbia University
Official's Role
Study Director
Facility Information:
Facility Name
Teachers College, Columbia University Center for Cerebral Palsy Research
City
New York
State/Province
New York
ZIP/Postal Code
10027
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17044964
Citation
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.
Results Reference
background
PubMed Identifier
25180530
Citation
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.
Results Reference
result
PubMed Identifier
17979861
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. doi: 10.1111/j.1469-8749.2007.00830.x.
Results Reference
result
PubMed Identifier
31434537
Citation
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.
Results Reference
derived
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Intensive Home-based Bimanual and Lower-limb Training in Young Children With Hemiplegia
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