Clinical trial NCT02918890: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Hemiplegia
Children
Keywords: Pediatric
HABIT
CIMT
Cerebral Palsy
Hemiplegia
Children
Therapy
Lead sponsor: Teachers College, Columbia University
Sponsor class: OTHER
Collaborators: name: Burke Medical Research Institute
First posted: 2016-09-29
Enrollment: 83
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Jebsen-Taylor Test of Hand Function
timeFrame: Baseline (pre-test), within 2 days after treatment (post-test), 6 months after treatment (follow-up)
measure: Assisting Hand Assessment
timeFrame: Baseline (pre-test), within 2 days after treatment (post-test), 6 months after treatment (follow-up)
measure: Box and Blocks Test
timeFrame: Baseline (pre-test), within 2 days after treatment (post-test), 6 months after treatment (follow-up)
Secondary outcomes:
measure: Canadian Occupational Performance Measure
timeFrame: Baseline (pre-test), within 2 days after treatment (post-test), 6 months after treatment (follow-up)
Other outcomes:
Locations:
city: New York
country: United States
facility: Teachers College, Columbia University Center for Cerebral Palsy Research
state: New York
Study officials:
affiliation: Teachers College, Columbia University
name: Andrew Gordon, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Burke Neurological Institute
name: Kathleen Friel, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.