Functional, neuroplastic and biomechanical changes induced by early Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (e-HABIT-ILE) in pre-school children with unilateral cerebral palsy: study protocol of a randomized control trial
Abstract Background Cerebral palsy (CP) causes motor, cognitive and sensory impairment at different extents. Many recent rehabilitation developments (therapies) have focused solely on the upper extremities (UE), although the lower extremities (LE) are commonly affected. Hand-arm Bimanual Intensive T...
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| Language: | English |
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BMC
2020-04-01
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| Series: | BMC Neurology |
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| Online Access: | http://link.springer.com/article/10.1186/s12883-020-01705-4 |
| _version_ | 1811222369839087616 |
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| author | R. Araneda S. V. Sizonenko C. J. Newman M. Dinomais G. Le Gal E. Nowak A. Guzzetta I. Riquelme S. Brochard Y. Bleyenheuft Early HABIT-ILE group |
| author_facet | R. Araneda S. V. Sizonenko C. J. Newman M. Dinomais G. Le Gal E. Nowak A. Guzzetta I. Riquelme S. Brochard Y. Bleyenheuft Early HABIT-ILE group |
| author_sort | R. Araneda |
| collection | DOAJ |
| description | Abstract Background Cerebral palsy (CP) causes motor, cognitive and sensory impairment at different extents. Many recent rehabilitation developments (therapies) have focused solely on the upper extremities (UE), although the lower extremities (LE) are commonly affected. Hand-arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) applies the concepts of motor skill learning and intensive training to both the UE and LE. It involves constant stimulation of the UE and LE, for several hours each day over a 2-week period. The effects of HABIT-ILE have never been evaluated in a large sample of young children. Furthermore, understanding of functional, neuroplastic and biomechanical changes in infants with CP is lacking. The aim of this study is to carry out a multi-center randomized controlled trial (RCT) to evaluate the effects of HABIT-ILE in pre-school children with unilateral CP on functional, neuroplastic and biomechanical parameters. Methods This multi-center, 3-country study will include 50 pre-school children with CP aged 1–4 years. The RCT will compare the effect of 50 h (two weeks) of HABIT-ILE versus usual motor activity, including regular rehabilitation. HABIT-ILE will be delivered in a day-camp setting, with structured activities and functional tasks that will be continuously progressed in terms of difficulty. Assessments will be performed at 3 intervals: baseline (T0), two weeks later and 3 months later. Primary outcomes will be the Assisting Hand Assessment; secondary outcomes include the Melbourne Assessment-2, executive function assessments, questionnaires ACTIVLIM-CP, Pediatric Evaluation of Disability Inventory, Young Children’s Participation and Environment Measure, Measure of the Process of Care, Canadian Occupational Performance Measure, as well as neuroimaging and kinematics measures. Discussion We expect that HABIT-ILE will induce functional, neuroplastic and biomechanical changes as a result of the intense, activity-based rehabilitation process and these changes will impact the whole developmental curve of each child, improving functional ability, activity and participation in the short-, mid- and long-term. Name of the registry: Changes Induced by Early HABIT-ILE in Pre-school Children With Uni- and Bilateral Cerebral Palsy (EarlyHABIT-ILE). Trial registration Trial registration number: NCT04020354 -Registration date on the International Clinical Trials Registry Platform (ICTRP): November 20th, 2018; Registration date on NIH Clinical Trials Registry: July 16th, 2019. |
| first_indexed | 2024-04-12T08:14:38Z |
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| id | doaj.art-a0342f77fe2749f1a311cff16c1c7e6f |
| institution | Directory Open Access Journal |
| issn | 1471-2377 |
| language | English |
| last_indexed | 2024-04-12T08:14:38Z |
| publishDate | 2020-04-01 |
| publisher | BMC |
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| series | BMC Neurology |
| spelling | doaj.art-a0342f77fe2749f1a311cff16c1c7e6f2022-12-22T03:40:51ZengBMCBMC Neurology1471-23772020-04-0120111010.1186/s12883-020-01705-4Functional, neuroplastic and biomechanical changes induced by early Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (e-HABIT-ILE) in pre-school children with unilateral cerebral palsy: study protocol of a randomized control trialR. Araneda0S. V. Sizonenko1C. J. Newman2M. Dinomais3G. Le Gal4E. Nowak5A. Guzzetta6I. Riquelme7S. Brochard8Y. Bleyenheuft9Early HABIT-ILE groupInstitute of Neuroscience, Université catholique de LouvainDivision of Child Development and Growth, Department of Pediatrics, University of GenevaPaediatric Neurology and Neurorehabilitation Unit, University Hospital of LausanneCHU Angers, Département de Médecine Physique et de Réadaptions, CHU Angers-CapucinsUniversity Hospital of BrestUniversity Hospital of BrestDepartment of Developmental Neuroscience, IRCCS Fondazione Stella MarisDepartment of Nursing and Physiotherapy and Research Institute on Health Sciences (UINICS-Idisba), University of the Balearic IslandsUniversity Hospital of BrestInstitute of Neuroscience, Université catholique de LouvainAbstract Background Cerebral palsy (CP) causes motor, cognitive and sensory impairment at different extents. Many recent rehabilitation developments (therapies) have focused solely on the upper extremities (UE), although the lower extremities (LE) are commonly affected. Hand-arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) applies the concepts of motor skill learning and intensive training to both the UE and LE. It involves constant stimulation of the UE and LE, for several hours each day over a 2-week period. The effects of HABIT-ILE have never been evaluated in a large sample of young children. Furthermore, understanding of functional, neuroplastic and biomechanical changes in infants with CP is lacking. The aim of this study is to carry out a multi-center randomized controlled trial (RCT) to evaluate the effects of HABIT-ILE in pre-school children with unilateral CP on functional, neuroplastic and biomechanical parameters. Methods This multi-center, 3-country study will include 50 pre-school children with CP aged 1–4 years. The RCT will compare the effect of 50 h (two weeks) of HABIT-ILE versus usual motor activity, including regular rehabilitation. HABIT-ILE will be delivered in a day-camp setting, with structured activities and functional tasks that will be continuously progressed in terms of difficulty. Assessments will be performed at 3 intervals: baseline (T0), two weeks later and 3 months later. Primary outcomes will be the Assisting Hand Assessment; secondary outcomes include the Melbourne Assessment-2, executive function assessments, questionnaires ACTIVLIM-CP, Pediatric Evaluation of Disability Inventory, Young Children’s Participation and Environment Measure, Measure of the Process of Care, Canadian Occupational Performance Measure, as well as neuroimaging and kinematics measures. Discussion We expect that HABIT-ILE will induce functional, neuroplastic and biomechanical changes as a result of the intense, activity-based rehabilitation process and these changes will impact the whole developmental curve of each child, improving functional ability, activity and participation in the short-, mid- and long-term. Name of the registry: Changes Induced by Early HABIT-ILE in Pre-school Children With Uni- and Bilateral Cerebral Palsy (EarlyHABIT-ILE). Trial registration Trial registration number: NCT04020354 -Registration date on the International Clinical Trials Registry Platform (ICTRP): November 20th, 2018; Registration date on NIH Clinical Trials Registry: July 16th, 2019.http://link.springer.com/article/10.1186/s12883-020-01705-4Cerebral palsyIntensive trainingToddlersRandomized controlled trialFunctional changesNeuroplasticity |
| spellingShingle | R. Araneda S. V. Sizonenko C. J. Newman M. Dinomais G. Le Gal E. Nowak A. Guzzetta I. Riquelme S. Brochard Y. Bleyenheuft Early HABIT-ILE group Functional, neuroplastic and biomechanical changes induced by early Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (e-HABIT-ILE) in pre-school children with unilateral cerebral palsy: study protocol of a randomized control trial BMC Neurology Cerebral palsy Intensive training Toddlers Randomized controlled trial Functional changes Neuroplasticity |
| title | Functional, neuroplastic and biomechanical changes induced by early Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (e-HABIT-ILE) in pre-school children with unilateral cerebral palsy: study protocol of a randomized control trial |
| title_full | Functional, neuroplastic and biomechanical changes induced by early Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (e-HABIT-ILE) in pre-school children with unilateral cerebral palsy: study protocol of a randomized control trial |
| title_fullStr | Functional, neuroplastic and biomechanical changes induced by early Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (e-HABIT-ILE) in pre-school children with unilateral cerebral palsy: study protocol of a randomized control trial |
| title_full_unstemmed | Functional, neuroplastic and biomechanical changes induced by early Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (e-HABIT-ILE) in pre-school children with unilateral cerebral palsy: study protocol of a randomized control trial |
| title_short | Functional, neuroplastic and biomechanical changes induced by early Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (e-HABIT-ILE) in pre-school children with unilateral cerebral palsy: study protocol of a randomized control trial |
| title_sort | functional neuroplastic and biomechanical changes induced by early hand arm bimanual intensive therapy including lower extremities e habit ile in pre school children with unilateral cerebral palsy study protocol of a randomized control trial |
| topic | Cerebral palsy Intensive training Toddlers Randomized controlled trial Functional changes Neuroplasticity |
| url | http://link.springer.com/article/10.1186/s12883-020-01705-4 |
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