1. Protocol of changes induced by early Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (e-HABIT-ILE) in pre-school children with bilateral cerebral palsy: a multisite randomized controlled trial
- Author
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Araneda, R., Sizonenko, S. V., Newman, C. J., Dinomais, M., Le Gal, G., Ebner-Karestinos, D., Paradis, J., Klocker, A., Saussez, G., Demas, J., Bailly, R., Bouvier, S., Nowak, E., Guzzetta, A., Riquelme, I., Brochard, S., Bleyenheuft, Y., and UCL - SSS/IONS/COSY - Systems & cognitive Neuroscience
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Male ,030506 rehabilitation ,extremidad superior ,parálisis cerebral ,medicine.medical_treatment ,humanos ,estudios multicéntricos como asunto ,lcsh:RC346-429 ,law.invention ,Study Protocol ,0302 clinical medicine ,Randomized controlled trial ,law ,Multicenter Studies as Topic ,Functional ability ,Child ,Biomechanical changes ,Motor skill ,Randomized Controlled Trials as Topic ,Bilateral cerebral palsy ,ddc:618 ,Rehabilitation ,Intensive training ,ensayos clínicos controlados aleatorizados como asunto ,Cognition ,General Medicine ,Bilateral ,Lower Extremity/physiopathology ,Lower Extremity ,Motor Skills ,Child, Preschool ,extremidad inferior ,Randomized controlled trials ,Female ,0305 other medical science ,Cerebral palsy ,Neuroplasticity ,Canada ,medicine.medical_specialty ,Upper Extremity/physiopathology ,habilidades motoras ,Upper Extremity ,03 medical and health sciences ,Physical medicine and rehabilitation ,modalidades de fisioterapia ,Motor Skills/physiology ,Intensive care ,medicine ,Humans ,Cerebral Palsy/rehabilitation ,Preschool ,Physical Therapy Modalities ,lcsh:Neurology. Diseases of the nervous system ,lactante ,business.industry ,Cerebral Palsy ,Infant ,medicine.disease ,Neurology (clinical) ,business ,030217 neurology & neurosurgery - Abstract
BackgroundCerebral palsy (CP), which is the leading cause of motor disability during childhood, can produce sensory and cognitive impairments at different degrees. Most recent therapeutic interventions for these patients have solely focused on upper extremities (UE), although more than 60% of these patients present lower extremities (LE) deficits. Recently, a new therapeutic concept, Hand-arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE), has been proposed, involving the constant stimulation of UE and LE. Based on motor skill learning principles, HABIT-ILE is delivered in a day-camp setting, promoting voluntary movements for several hours per day during 10 consecutive week days. Interestingly, the effects of this intervention in a large scale of youngsters are yet to be observed. This is of interest due to the lack of knowledge on functional, neuroplastic and biomechanical changes in infants with bilateral CP. The aim of this randomized controlled study is to assess the effects of HABIT-ILE adapted for pre-school children with bilateral CP regarding functional, neuroplastic and biomechanical factors.MethodsThis international, multicentric study will include 50 pre-school children with CP from 12 to 60months of age, comparing the effect of 50h (2weeks) of HABIT-ILE versus regular motor activity and/or customary rehabilitation. HABIT-ILE presents structured activities and functional tasks with continuous increase in difficulty while the child evolves. Assessments will be performed at 3 period times: baseline, two weeks later and 3months later. The primary outcome will be the Gross Motor Function Measure 66. Secondary outcomes will include Both Hands Assessment, Melbourne Assessment-2, Semmes-Weinstein Monofilament Test, algometry assessments, executive function tests, ACTIVLIM-CP questionnaire, Pediatric Evaluation of Disability Inventory (computer adaptative test), Young Children's Participation and Environment Measure, Measure of the Process of Care, Canadian Occupational Performance Measure, neuroimaging and kinematics.DiscussionThe results of this study should highlight the impact of a motor, intensive, goal-directed therapy (HABIT-ILE) in pre-school children at a functional, neuroplastic and biomechanical level. In addition, this changes could demonstrated the impact of this intervention in the developmental curve of each child, improving functional ability, activity and participation in short-, mid- and long-term.Name of the registryEvaluation of Functional, Neuroplastic and Biomechanical Changes Induced by an Intensive, Playful Early-morning Treatment Including Lower Limbs (EARLY-HABIT-ILE) in Preschool Children With Uni and Bilateral Cerebral Palsy (HABIT-ILE).Trial registrationNCT04017871Registration dateJuly 12, 2019., This protocol and trial is funded by La Fondation Paralysie Cerebrale (https://www.fondationparalysiecerebrale.org/).The funding body has reviewed this protocol during the selection process, but after this initial point, the Fondation Paralysie Cerebrale has not participated in the design study and will not participate in data collection, analysis, interpretation data or in writing the manuscript.
- Published
- 2020
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