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 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 preschool children with unilateral CP on functional, neuroplastic and biomechanical parameters.

Early, Intensive, Lower Extremity Rehabilitation Shows Preliminary Efficacy After Perinatal Stroke: Results of a Pilot Randomized Controlled Trial

“…While most of these early interventions target the upper extremities, some have included the lower extremity. 10,11 Here, we show that early, activity-based intervention focused on the lower extremity is feasible and can improve gross motor function.…”

“…In contrast, active treatment approaches for the lower extremity are limited for young children with CP, 7 although some studies combining upper and lower extremity training show promise 9,10 or are underway. 11 Optimizing lower extremity function is especially important now because of the recent reduction in severity of CP among developed countries, resulting in more children with the potential to walk. 12 Current clinical practice for lower extremity function in young children with CP is often passive in nature, typically waiting until clinical signs appear, then focusing on static stretching, the traditional Neural Developmental Therapy (NDT), bracing with ankle-foot orthoses and botulinum toxin injection of spastic muscles, [13][14][15] a "wait-and-see"approach.…”

Early, intensive rehabilitation improves gross motor function after perinatal stroke: results of a randomized controlled trial

“…GAME, HABIT-ILE, small steps, baby-CIMT, baby-bimanual, reviewed in 15,43 ). While most of these early interventions target the upper extremities, some have included the lower extremity 10,11 . Here, we show that early, activity-based intervention focused on the lower extremity can substantially improve gross motor function.…”

“…constraint-induced movement therapy [CIMT] and bimanual training, reviewed in [6][7][8] ). In contrast, active treatment approaches for the lower extremity are limited for young children with CP 7 , although some studies combining upper and lower extremity training show promise 9,10 or are underway 11 . Optimizing lower extremity function is especially important now, because of the recent reduction in severity of CP among developed countries, resulting in more children with the potential to walk 12 .…”

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

“…Children will endure a standardized gradual familiarization program aiming to become comfortable in the MRI environment. The familiarization will include the use of ear-plugs to sleep, particular observation of the child's sleep routine and feeding immediately before the scan in spontaneous sleep process [51,52]. The total time of MRI is estimated to 20 min.…”