Intensive Unimanual (CIMT) and Bimanual Training (HABIT) in Children With Hemiplegia

Sponsor

Teachers College, Columbia University (Other)

Overall Status

Completed

CT.gov ID

NCT02918890

Collaborator

Burke Medical Research Institute (Other)

Enrollment

Location

Arms

Duration (Months)

1.6

Patients Per Site Per Month

Study Details

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/

Condition or Disease	Intervention/Treatment	Phase
Cerebral Palsy Hemiplegia Children	Other: Constraint-induced Movement Therapy Other: Hand-arm Bimanual Intensive Therapy	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

84 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Intensive Unimanual (CIMT) and Bimanual Training (HABIT) in Children With Hemiplegia

Study Start Date :

Sep 1, 2014

Actual Primary Completion Date :

Jan 1, 2019

Actual Study Completion Date :

Jan 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CIMT Procedure: Constraint-Induced Movement Therapy 90 hours Other Name: CIT, CI Therapy, restraint therapy, PT, OT, rehab	Other: Constraint-induced Movement Therapy
Experimental: HABIT Procedure: Hand-Arm Bimanual Intensive Therapy (HABIT) 90 hours Other Name: HABIT, bimanual training, bilateral training, restraint therapy, PT, OT, rehab	Other: Hand-arm Bimanual Intensive Therapy

Arm

Intervention/Treatment

Experimental: CIMT

Procedure: Constraint-Induced Movement Therapy 90 hours Other Name: CIT, CI Therapy, restraint therapy, PT, OT, rehab

Other: Constraint-induced Movement Therapy

Experimental: HABIT

Procedure: Hand-Arm Bimanual Intensive Therapy (HABIT) 90 hours Other Name: HABIT, bimanual training, bilateral training, restraint therapy, PT, OT, rehab

Other: Hand-arm Bimanual Intensive Therapy

Outcome Measures

Primary Outcome Measures

Jebsen-Taylor Test of Hand Function [Change from baseline to immediately after intervention]
Assisting Hand Assessment [Change from baseline to immediately after intervention]
Box and Blocks test [Change from baseline to immediately after intervention]

Secondary Outcome Measures

Canadian Occupational Performance Measure [Change from baseline to immediately after intervention]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Teachers College, Columbia University Center for Cerebral Palsy Research	New York	New York	United States	10027

Sponsors and Collaborators

Teachers College, Columbia University
Burke Medical Research Institute

Investigators

Principal Investigator: Andrew Gordon, Ph.D., Teachers College, Columbia University
Principal Investigator: Kathleen Friel, Ph.D., Burke Neurological Institute