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

Autor: 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.
Přispěvatelé: UCL - SSS/IONS/COSY - Systems & cognitive Neuroscience
Jazyk: angličtina
Rok vydání: 2020
Předmět:
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
Zdroj: BMC Neurology, Vol 20, Iss 1, Pp 1-10 (2020)
BMC neurology, vol. 20, no. 1, pp. 243
BMC Neurology
BMC Neurology, Vol. 20, no. 1, p. 243 (2020)
BMC Neurology, Vol. 20, No 1 (2020) P. 243
ISSN: 1471-2377
DOI: 10.1186/s12883-020-01820-2
Popis: 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.
Databáze: OpenAIRE
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