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

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

Sponsors

Lead Sponsor: Teachers College, Columbia University

Collaborator: Burke Medical Research Institute

Source Teachers College, Columbia University
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.

Overall Status Active, not recruiting
Start Date September 2014
Completion Date December 31, 2020
Primary Completion Date August 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
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
Measure Time Frame
Canadian Occupational Performance Measure Change from baseline to immediately after intervention
Enrollment 84
Condition
Intervention

Intervention Type: Other

Intervention Name: Constraint-induced Movement Therapy

Arm Group Label: CIMT

Intervention Type: Other

Intervention Name: Hand-arm Bimanual Intensive Therapy

Arm Group Label: HABIT

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

Gender: All

Minimum Age: 6 Years

Maximum Age: 17 Years

Healthy Volunteers: No

Overall Official
Location
Facility: Teachers College, Columbia University Center for Cerebral Palsy Research
Location Countries

United States

Verification Date

September 2018

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: CIMT

Type: Experimental

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

Label: HABIT

Type: Experimental

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

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov