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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02918890
• Other study ID #: 14-140
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: January 31, 2019

Study information

• Verified date: December 2021
• Source: Teachers College, Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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/

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: January 31, 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Children
• Hemiplegia

Intervention

Other:
• Constraint-induced Movement Therapy

• Hand-arm Bimanual Intensive Therapy

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Teachers College, Columbia University	Burke Medical Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (6)

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

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. — View 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. — View 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): — 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

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Jebsen-Taylor Test of Hand Function		Change from baseline to immediately after intervention
Primary	Assisting Hand Assessment		Change from baseline to immediately after intervention
Primary	Box and Blocks test		Change from baseline to immediately after intervention
Secondary	Canadian Occupational Performance Measure		Change from baseline to immediately after intervention