Intensive Unimanual (CIMT) and Bimanual Training (HABIT) in Children With Hemiplegia
- Conditions
- Cerebral PalsyChildrenHemiplegia
- Interventions
- Other: Constraint-induced Movement TherapyOther: Hand-arm Bimanual Intensive Therapy
- Registration Number
- NCT02918890
- Lead Sponsor
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 83
- Diagnosis of unilateral cerebral palsy
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CIMT Constraint-induced Movement Therapy Procedure: Constraint-Induced Movement Therapy 90 hours Other Name: CIT, CI Therapy, restraint therapy, PT, OT, rehab HABIT Hand-arm Bimanual Intensive Therapy Procedure: Hand-Arm Bimanual Intensive Therapy (HABIT) 90 hours Other Name: HABIT, bimanual training, bilateral training, restraint therapy, PT, OT, rehab
- Primary Outcome Measures
Name Time Method Jebsen-Taylor Test of Hand Function Baseline (pre-test), within 2 days after treatment (post-test), 6 months after treatment (follow-up) The JTTHF measures the time taken to complete six unimanual tasks, which include flipping cards, moving small objects, and lifting cans. The total score is the amount of time taken (in seconds) to complete all tasks. A lower score means a better outcome.
Assisting Hand Assessment Baseline (pre-test), within 2 days after treatment (post-test), 6 months after treatment (follow-up) The AHA is a validated test for measuring bimanual hand use in children with UE impairments. The AHA measures the use of the more affected hand in bimanual activities during a play-like testing session. Sessions were videotaped and scored off-site by a blinded evaluator. The AHA has excellent validity, reliability (0.97-0.99) and responsiveness to change. The AHA units were used for the analysis (range 0-100). The smallest detectable difference (SDD) for AHA is an improvement of at least 5 units. A higher score means a better outcome.
Box and Blocks Test Baseline (pre-test), within 2 days after treatment (post-test), 6 months after treatment (follow-up) The BBT measures how many blocks (2.5 cm3) an individual can move from one box, over a barrier, to an adjacent box in 1 min. Both hands were tested. The BBT is valid and reliable for children with CP. A higher score means a better outcome.
- Secondary Outcome Measures
Name Time Method Canadian Occupational Performance Measure Baseline (pre-test), within 2 days after treatment (post-test), 6 months after treatment (follow-up) The COPM is a structured interview in which the individuals are asked to identify up to five functional goals. In this study, parents reported their child's functional goals. Parents rated how well children perform each goal (COPM-Performance), and how satisfied they were with the child's performance (COPM-Satisfaction). The same caregiver was interviewed before and after the intervention. A change of 2 or more points in each scale of COPM is considered a minimum clinically important difference (MCID). The COPM has been validated for parents of children with disabilities. A high score means a better outcome (range 0-10).
Trial Locations
- Locations (1)
Teachers College, Columbia University Center for Cerebral Palsy Research
🇺🇸New York, New York, United States