Intensive Unimanual (CIMT) and Bimanual Training (HABIT) in Children With Hemiplegia
Primary Purpose
Cerebral Palsy, Hemiplegia, Children
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Constraint-induced Movement Therapy
Hand-arm Bimanual Intensive Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring Pediatric, HABIT, CIMT, Cerebral Palsy, Hemiplegia, Children, Therapy
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of unilateral cerebral palsy
Exclusion Criteria:
- Current medical illness unrelated to CP
- Seizure disorder
- Current use of medications know to lower the seizure threshold
- Metallic object(s) in body, other than dental fillings
- Pregnancy
- Claustrophobia
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
CIMT
HABIT
Arm Description
Procedure: Constraint-Induced Movement Therapy 90 hours Other Name: CIT, CI Therapy, restraint therapy, PT, OT, rehab
Procedure: Hand-Arm Bimanual Intensive Therapy (HABIT) 90 hours Other Name: HABIT, bimanual training, bilateral training, restraint therapy, PT, OT, rehab
Outcomes
Primary Outcome Measures
Jebsen-Taylor Test of Hand Function
Assisting Hand Assessment
Box and Blocks test
Secondary Outcome Measures
Canadian Occupational Performance Measure
Full Information
NCT ID
NCT02918890
First Posted
September 27, 2016
Last Updated
December 14, 2021
Sponsor
Teachers College, Columbia University
Collaborators
Burke Medical Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02918890
Brief Title
Intensive Unimanual (CIMT) and Bimanual Training (HABIT) in Children With Hemiplegia
Official Title
Intensive Unimanual (CIMT) and Bimanual Training (HABIT) in Children With Hemiplegia
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
January 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Teachers College, Columbia University
Collaborators
Burke Medical Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A randomized control trial examining the relationship between changes in hand function and brain plasticity following intensive therapy. Two treatment approaches are used: constraint-induced movement therapy (CIMT) or Hand-Arm Bimanual Intensive Therapy (HABIT). The protocols have been developed at TC Columbia University to be child friendly and draw upon our extensive experience with constraint-induced movement therapy in children with cerebral palsy. Our center has been providing interventions camps for children with cerebral palsy since 1998. The interventions are performed in a 15 day day-camp setting with several children and at least one interventionist per child. The aim of the intervention is to improve the use of the affected hand and quality of overall movement in a fun, social setting. PARTICIPATION IS FREE. Please check out our website for more information: http://www.tc.edu/centers/cit/
Detailed Description
Constraint-induced Movement Therapy and Bimanual training are motor-learning based approaches to engage children in fun activities. This study looks at what areas of the brain are responsible for recovery after intensive training. We are trying to understand how the brain responds to movement training and hope that in the future we can develop new treatments for hemiplegia based on what we learn about the brain in this study.
To study the areas of the brain we will use Magnetic Resonance Imaging (MRI) to take pictures of the brain and Transcranial Magnetic Stimulation (TMS) to determine parts of the brain involved in using the hand. TMS uses a brief magnetic field over the scalp by using a wand that looks like a figure 8. The wand can make brief magnetic fields over a series of spots on your child's head to activate the brain cells under the wand. Non-invasive, single pulse TMS will be used in this study, which is considered minimal risk and tolerable to children. If your child has a recurrent history of seizures after two years of age, he/she might not qualify.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Hemiplegia, Children
Keywords
Pediatric, HABIT, CIMT, Cerebral Palsy, Hemiplegia, Children, Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CIMT
Arm Type
Experimental
Arm Description
Procedure: Constraint-Induced Movement Therapy 90 hours Other Name: CIT, CI Therapy, restraint therapy, PT, OT, rehab
Arm Title
HABIT
Arm Type
Experimental
Arm Description
Procedure: Hand-Arm Bimanual Intensive Therapy (HABIT) 90 hours Other Name: HABIT, bimanual training, bilateral training, restraint therapy, PT, OT, rehab
Intervention Type
Other
Intervention Name(s)
Constraint-induced Movement Therapy
Intervention Type
Other
Intervention Name(s)
Hand-arm Bimanual Intensive Therapy
Primary Outcome Measure Information:
Title
Jebsen-Taylor Test of Hand Function
Time Frame
Change from baseline to immediately after intervention
Title
Assisting Hand Assessment
Time Frame
Change from baseline to immediately after intervention
Title
Box and Blocks test
Time Frame
Change from baseline to immediately after intervention
Secondary Outcome Measure Information:
Title
Canadian Occupational Performance Measure
Time Frame
Change from baseline to immediately after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of unilateral cerebral palsy
Exclusion Criteria:
Current medical illness unrelated to CP
Seizure disorder
Current use of medications know to lower the seizure threshold
Metallic object(s) in body, other than dental fillings
Pregnancy
Claustrophobia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Gordon, Ph.D.
Organizational Affiliation
Teachers College, Columbia University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kathleen Friel, Ph.D.
Organizational Affiliation
Burke Neurological Institute
Official's Role
Principal Investigator
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
21950396
Citation
Gordon AM. To constrain or not to constrain, and other stories of intensive upper extremity training for children with unilateral cerebral palsy. Dev Med Child Neurol. 2011 Sep;53 Suppl 4:56-61. doi: 10.1111/j.1469-8749.2011.04066.x.
Results Reference
background
PubMed Identifier
16836774
Citation
Charles JR, Wolf SL, Schneider JA, Gordon AM. Efficacy of a child-friendly form of constraint-induced movement therapy in hemiplegic cerebral palsy: a randomized control trial. Dev Med Child Neurol. 2006 Aug;48(8):635-42. doi: 10.1017/S0012162206001356.
Results Reference
result
PubMed Identifier
16510616
Citation
Gordon AM, Charles J, Wolf SL. Efficacy of constraint-induced movement therapy on involved upper-extremity use in children with hemiplegic cerebral palsy is not age-dependent. Pediatrics. 2006 Mar;117(3):e363-73. doi: 10.1542/peds.2005-1009.
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
21700924
Citation
Gordon AM, Hung YC, Brandao M, Ferre CL, Kuo HC, Friel K, Petra E, Chinnan A, Charles JR. Bimanual training and constraint-induced movement therapy in children with hemiplegic cerebral palsy: a randomized trial. Neurorehabil Neural Repair. 2011 Oct;25(8):692-702. doi: 10.1177/1545968311402508. Epub 2011 Jun 23.
Results Reference
result
PubMed Identifier
34012418
Citation
Friel KM, Ferre CL, Brandao M, Kuo HC, Chin K, Hung YC, Robert MT, Flamand VH, Smorenburg A, Bleyenheuft Y, Carmel JB, Campos T, Gordon AM. Improvements in Upper Extremity Function Following Intensive Training Are Independent of Corticospinal Tract Organization in Children With Unilateral Spastic Cerebral Palsy: A Clinical Randomized Trial. Front Neurol. 2021 May 3;12:660780. doi: 10.3389/fneur.2021.660780. eCollection 2021.
Results Reference
derived
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Intensive Unimanual (CIMT) and Bimanual Training (HABIT) in Children With Hemiplegia
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