Hand-arm Bimanual Intensive Therapy Research Articles

A gamified social robotics platform for intensive therapies in neurorehabilitation

The use of social assistive robots for interactive stimulation has strong potential in neurorehabilitation therapies. It is of particular interest in the case of pediatric patients to promote children’s motivation and adherence, specially when those robots are able of guide gamified activities, as it is the case of NAOTherapist. NAOTherapist is a Social Assistive Robotics (SAR) platform for hands-off rehabilitation based on upper-limb activities, that was originally designed for pediatric patients with Cerebral Palsy (CP) or Obstetric Braxial Plexus Palsy (OBPP). Formerly, it endowed the therapists with tools to perform rehabilitation exercises. This paper proposes the gamification of NAOTherapist in order to incorporate additional characteristics which allow its intensive use in new rehabilitation procedures, such as the Hand-Arm Bimanual Intensive Therapy (HABIT). This intensive therapy setting involves daily activities in several consecutive days, which require a strong engagement of the patients with the therapeutic methods and the acceptation of the NAOTherapist as a rehabilitation system. The gamified system shows very accurate results considering the different aspects defined in the USUS methodology; namely Usability, Social acceptance, User experience and Societal impact.

Changes Induced by Early Hand-Arm Bimanual Intensive Therapy Including Lower Extremities in Young Children With Unilateral Cerebral Palsy

Intensive interventions are provided to young children with unilateral cerebral palsy (UCP), classically focused on the upper extremity despite the frequent impairment of gross motor function. Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) effectively improves manual dexterity and gross motor function in school-aged children. To verify if HABIT-ILE would improve manual abilities in young children with UCP more than usual motor activity. This prospective randomized clinical trial (November 2018 to December 2021), including 2 parallel groups and a 1:1 allocation, recruitment took place at European university hospitals, cerebral palsy specialized centers, and spontaneous applications at 3 sites: Brussels, Belgium; Brest, France; and Pisa, Italy. Matched (age at inclusion, lesion type, cause of cerebral palsy, and affected side) pairs randomization was performed. Young children were assessed at baseline (T0), 2 weeks after baseline (T1), and 3 months after baseline (T2). Health care professionals and assessors of main outcomes were blinded to group allocation. At least 23 young children (in each group) aged 12 to 59 months with spastic/dyskinetic UCP and able to follow instructions were needed. Exclusion criteria included uncontrolled seizures, scheduled botulinum toxin injections, orthopedic surgery scheduled during the 6 months before or during the study period, severe visual/cognitive impairments, or contraindications to magnetic resonance imaging. Two weeks of usual motor activity including usual rehabilitation (control group) vs 2 weeks (50 hours) of HABIT-ILE (HABIT-ILE group). Primary outcome: Assisting Hand Assessment (AHA); secondary outcomes: Gross Motor Function Measure-66 (GMFM-66), Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (PEDI-CAT), and Canadian Occupational Performance Measure (COPM). Of 50 recruited young children (26 girls [52%], median age; 35.3 months for HABIT-ILE group; median age, 32.8 months for control group), 49 were included in the final analyses. Change in AHA score from T0 to T2 was significantly greater in the HABIT-ILE group (adjusted mean score difference [MD], 5.19; 95% CI, 2.84-7.55; P < .001). Changes in GMFM-66 (MD, 4.72; 95% CI, 2.66-6.78), PEDI-CAT daily activities (MD, 1.40; 95% CI, 0.29-2.51), COPM performance (MD, 3.62; 95% CI, 2.91-4.32), and satisfaction (MD, 3.53; 95% CI, 2.70-4.36) scores were greater in the HABIT ILE group. In this clinical trial, early HABIT-ILE was shown to be an effective treatment to improve motor performance in young children with UCP. Moreover, the improvements had an impact on daily life activities of these children. ClinicalTrials.gov Identifier: NCT04020354.

Virtual Reality and Active Video Game Integration within an Intensive Bimanual Therapy Program for Children with Hemiplegia

Aims To describe the nature of custom and non-custom virtual reality and active video game (VR/AVG) implementation within a Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) intervention program for children with hemiplegia. Methods Six children aged 8-11 years participated in a 10-day HABIT-ILE intervention (65 h; 6.5 planned VR/AVG hours). VR/AVG implementation details were recorded daily and summarized with descriptive statistics; active motor engagement was quantified as minutes of active game participation. Post-intervention interviews with interventionists were analyzed with qualitative content analysis. Results On average, participants received 79% of the planned VR/AVG dosage (314/400 planned minutes, range 214–400 min), of which the per-session active motor engagement average was 68% (27 min, SD 12 min). Participation involved equivalent amounts of custom (49%) and non-custom (51%) VR/AVG system use. Material and verbal adaptations facilitated alignment with HABIT-ILE principles. Interventionists identified type of task (gross versus fine motor), children’s perceived motivation, and VR/AVG attributes as factors influencing active motor engagement and alignment with HABIT-ILE principles. Conclusions Describing individual and technological challenges of VR/AVG integration within HABIT-ILE can advance knowledge about VR/AVG use in intensive interventions and identify directions for subsequent research.

Bimanual Movement Characteristics and Real-World Performance Following Hand-Arm Bimanual Intensive Therapy in Children with Unilateral Cerebral Palsy.

The purpose of this study was to quantify characteristics of bimanual movement intensity during 30 h of hand-arm bimanual intensive therapy (HABIT) and bimanual performance (activities and participation) in real-world settings using accelerometers in children with unilateral cerebral palsy (UCP). Twenty-five children with UCP participated in a 30 h HABIT program. Data were collected from bilateral wrist-worn accelerometers during 30 h of HABIT to quantify the movement intensity and three days pre- and post-HABIT to assess real-world performance gains. Movement intensity and performance gains were measured using six standard accelerometer-derived variables. Bimanual capacity (body function and activities) was assessed using standardized hand function tests. We found that accelerometer variables increased significantly during HABIT, indicating increased bimanual symmetry and intensity. Post-HABIT, children demonstrated significant improvements in all accelerometer metrics, reflecting real-world performance gains. Children also achieved significant and clinically relevant changes in hand capacity following HABIT. Therefore, our findings suggest that accelerometers can objectively quantify bimanual movement intensity during HABIT. Moreover, HABIT enhances hand function as well as activities and participation in real-world situations in children with UCP.

Efficacy of integrating a semi-immersive virtual device in the HABIT-ILE intervention for children with unilateral cerebral palsy: a non-inferiority randomized controlled trial

BackgroundThe implementation of virtual devices can facilitate the role of therapists (e.g., patient motivation, intensity of practice) to improve the effectiveness of treatment for children with cerebral palsy. Among existing therapeutic devices, none has been specifically designed to promote the application of principles underlying evidence-based motor skill learning interventions. Consequently, evidence is lacking regarding the effectiveness of virtual-based sessions in motor function rehabilitation with respect to promoting the transfer of motor improvements into daily life activities. We tested the effectiveness of implementing a recently developed virtual device (REAtouch®), specifically designed to enable the application of therapeutic motor skill learning principles, during a Hand Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) intervention.MethodsForty children with unilateral cerebral palsy (5–18 years; MACS I-III; GMFCS I-II) were randomly assigned to a control group or a “REAtouch®” experimental group for a 90-h HABIT-ILE day-camp intervention (two weeks). Children in the REAtouch® group spent nearly half of their one-on-one therapeutic time using the REAtouch®. Participants underwent three testing sessions: the week before (T1), after intervention (T2), and at three months follow-up (T3). The primary outcome was the Assisting Hand Assessment (T3–T1; blinded). Secondary outcomes measured uni-bimanual hand function, stereognosis, gait endurance, daily life abilities, and functional goals. Accelerometers and a manual report of daily activities served to document therapeutic dosage and treatment characteristics. We used one-way RMANOVA to compare the efficacies of the two interventions, and non-inferiority analyses to contrast changes in the “REAtouch®” group versus the “HABIT-ILE” control group.ResultsWe found significant improvements in both groups for most of the outcome measures (p < 0.05). There was significant non-inferiority of changes in the REAtouch® group for upper extremities motor function, functional goals attainment, and abilities in daily life activities (p < 0.05).ConclusionsUse of the REAtouch® device during HABIT-ILE showed non-inferior efficacy compared to the conventional evidence-based HABIT-ILE intervention in children with unilateral cerebral palsy. This study demonstrates the feasibility of using this virtual device in a high dosage camp model, and establishes the possibility of applying the therapeutic principles of motor skill learning during specifically designed virtual-based sessions.Trial registration: Trial registration number: NCT03930836-Registration date on the International Clinical Trials Registry Platform (ICTRP): June 21th, 2018; Registration date on NIH Clinical Trials Registry: April 29th, 2019. First patient enrollment: July 3rd, 2018.

Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) in adults with chronic stroke: protocol of a randomised controlled trial

IntroductionStroke causes multiple deficits including motor, sensitive and cognitive impairments, affecting also individual’s social participation and independence in activities of daily living (ADL) impacting their quality of life. It has...

Evidence-Based, Implementable Motor Rehabilitation Guidelines for Individuals With Cerebral Palsy

Cerebral palsy is a life-long condition that causes heterogeneous motor disorders. Motor rehabilitation interventions must be adapted to the topography of the symptoms, ambulatory capacity, and age of the individual. Current guidelines do not differentiate between the different profiles of individuals with cerebral palsy, which limits their implementation. To develop evidence-based, implementable guidelines for motor rehabilitation interventions for individuals with cerebral palsy according to the age, topography of the cerebral palsy, and ambulatory capacity of the individual and to determine a level of priority for each intervention. We used a mixed methods design that combined a systematic review of the literature on available motor rehabilitation interventions with expert opinions. Based on the French National Authority for Health methodology, recommendations were graded as strong, conditional, or weak. Interventions were then prioritized by the experts according to both the evidence and their own opinions on relevance and implementability to provide a guide for clinicians. All recommendations were approved by experts who were independent from the working group. Strong recommendations as first-line treatments were made for gait training, physical activities, and hand-arm bimanual intensive therapy for all children and adolescents with cerebral palsy. Moderate recommendations were made against passive joint mobilizations, muscle stretching, prolonged stretching with the limb fixed, and neurodevelopmental therapies for all children and adolescents with cerebral palsy. Strong recommendations as first-line treatments were made for gait training for all adults with cerebral palsy and moderate recommendations as moderate importance interventions for strengthening exercises and ankle-foot orthoses for motor impairment of the feet and the ankles. These guidelines, which combine research evidence and expert opinions, could help individuals with cerebral palsy and their families to codetermine rehabilitation goals with health professionals, according to their preferences.

Effect of hand arm bimanual intensive therapy (HABIT) on gross motor functions in upper extremity of spastic CP

To review studies that can examine whether there’s effect of hand arm bimanual intensive training(HABIT) and neurodevelopmental treatment on gross motor function in spastic cerebral palsy. Journal articles published between 2011 and 2021 were secured by searching computerized bibliographical databases. High evidence studies as randomized control trials, systematic reviews and cross sectional studies were included. A total of 30 studies were selected. After analyzing the studies, it was seen that; there is effect of HABIT in upper extremity on gross motor function, functional training , manual dexterity and activities of daily living and NDT was also improved gross motor function, spasticity and strength in upper extremity.

HABIT+tDCS: a study protocol of a randomised controlled trial (RCT) investigating the synergistic efficacy of hand-arm bimanual intensive therapy (HABIT) plus targeted non-invasive brain stimulation to improve upper extremity function in school-age children with unilateral cerebral palsy

IntroductionUnilateral spastic cerebral palsy (USCP) is characterised by movement deficits primarily on one body side. The best available upper extremity (UE) therapies are costly and intensive. Thus, there is an...

Effect of hand arm bimanual intensive therapy on upper limb function in young stroke

Effect of hand arm bimanual intensive therapy on upper limb function in young stroke

Use of a Caregiver Coaching Model for Implementation of Intensive Motor Training for Hemiplegic Cerebral Palsy: A Case Study

Background: There is extensive literature to support the efficacy of both pediatric constraint-induced movement therapy (pCIMT) and hand-arm bimanual intensive therapy (HABIT) for children with hemiplegic cerebral palsy. In addition, there is increasing evidence to support the training of caregivers (parents and other care providers) to carry out therapy interventions in the home. The Family Activity Adaptation Model (FAAM) presents guidelines for parent and caregiver coaching for intensive therapies used in occupational therapy practice.

Intensive Bimanual Intervention for Children Who Have Undergone Hemispherectomy: A Pilot Study.

To conduct a pilot study to assess the feasibility and effectiveness of an intensive bimanual intervention on upper limb function in children who have undergone hemispherectomy. Thirteen children received 90 hours of intensive bimanual training (Hand-Arm Bimanual Intensive Therapy, HABIT). The Jebsen-Taylor Test of Hand Function (JTTHF), Box and Block Test (BBT), Assisting Hand Assessment (AHA), ABILHAND-Kids, and Canadian Occupational Performance Measure (COPM) were assessed by a masked clinician twice before, immediately, and 6 months after treatment. Significant improvements over time were found in the JTTHF, AHA, ABILHAND-Kids, and COPM. Completion of HABIT was feasible for children with hemispherectomy. Improvement of bimanual function and functional goals can be related to the nature of the activities prioritized in HABIT training.

Corpus Callosum Integrity Relates to Improvement of Upper-Extremity Function Following Intensive Rehabilitation in Children With Unilateral Spastic Cerebral Palsy

Background The corpus callosum (CC) plays an important role in upper extremity (UE) function. The impact on UE function in children with unilateral spastic cerebral palsy (USCP) and improvements following intensive interventions remain unknown. Objectives To examine the (1) relationship between UE function and CC integrity and (2) relationship between CC integrity and changes in UE function following intensive interventions. Methods We retrospectively analyzed clinical and neuroimaging data from a sample of convenience of 44 participants (age 9.40 ± 3.10 years) from 2 larger trials. Participants received 90 hours of Hand-Arm Bimanual Intensive Therapy (HABIT) or Constraint-Induced Movement Therapy (CIMT). Unimanual dexterity (Jebsen-Taylor Test of Hand Function [JTTHF]) and bimanual performance (Assisting Hand Assessment [AHA]) were assessed preintervention and postintervention. CC tractography was reconstructed with diffusion tensor imaging (DTI) and segmented into 3 regions (genu, midbody, splenium). Pearson correlations and regression were used to assess the relationship between outcomes and DTI parameters (ie, fractional anisotropy [FA], number of streamlines, and mean, radial, and axial diffusivity). Results Both groups improved in bimanual performance (P < .01). The CIMT group improved in unimanual dexterity (P < .01). Baseline unimanual dexterity and bimanual performance correlated with FA and number of streamlines for most CC regions (P < .05). Following CIMT, pre-post changes in JTTHF were negatively correlated with axial and radial diffusivity of the CC, and AHA with splenium and number of streamlines for the CC, midbody, and splenium (all P < .05). Following HABIT, midbody FA was positively correlated with pre-post AHA changes (r = 0.417; P = .042). Conclusions CC integrity is important for UE function in children with USCP.

Brain activation changes following motor training in children with unilateral cerebral palsy: An fMRI study.

Intensive motor-learning-based interventions have demonstrated efficacy for improving motor function in children with unilateral spastic cerebral palsy (USCP). Although this improvement has been associated mainly with neuroplastic changes in the primary sensori-motor cortices, this plasticity may also involve a wider fronto-parietal network for motor learning. To determine whether hand-arm bimanual intensive therapy including lower extremities (HABIT-ILE) induces brain activation changes in an extensive network for motor skill learning and whether these changes are related to functional changes observed after HABIT-ILE. In total, 25 children with USCP were behaviourally assessed in manual dexterity and everyday activities before and after HABIT-ILE. Functional imagery monitored brain activity while participants manipulated objects using their less-affected, more-affected or both hands. Two random-effects-group analyses performed at the whole-brain level assessed the brain activity network before and after therapy. Three other random-effects-group analyses assessed brain activity changes after therapy. Spearman's correlations were used to evaluate the correlation between behavioural and brain activity changes. The same fronto-parietal network was identified before and after therapy. After the intervention, the more-affected hand manipulation elicited a decrease in activity on the motor cortex of the non-lesional hemisphere and an increase in activity on motor areas of the lesional hemisphere. The less-affected hand manipulation generated a decrease in activity of sensorimotor areas in the non-lesional hemisphere. Both-hands manipulation elicited an increase in activity of both hemispheres. Furthermore, we observed an association between brain activity changes and changes in everyday activity assessments. Brain activation changes were observed in a fronto-parietal network underlying motor skill learning with HABIT-ILE in children with USCP. Two different patterns were observed, probably related to different phases of motor skill learning, representing an increased practice-dependent brain recruitment or a brain activation refinement by more efficient means. CLINICALTRIALS.GOV: NCT01700777 &NCT02667613.

Speech Treatment Effects on Narrative Intelligibility in French-Speaking Children With Dysarthria.

Purpose This study examined the effects of Speech Intelligibility Treatment (SIT) on intelligibility and naturalness of narrative speech produced by francophone children with dysarthria due to cerebral palsy. Method Ten francophone children with dysarthria were randomized to one of two treatments, SIT or Hand-Arm Bimanual Intensive Therapy Including Lower Extremities, a physical therapy (PT) treatment. Both treatments were conducted in a camp setting and were comparable in dosage. The children were recorded pre- and posttreatment producing a story narrative. Intelligibility was measured by means of 60 blinded listeners' orthographic transcription accuracy (percentage of words transcribed correctly). The listeners also rated the children's naturalness on a visual analogue scale. Results A significant pre- to posttreatment increase in intelligibility was found for the SIT group, but not for the PT group, with great individual variability observed among the children. No significant changes were found for naturalness ratings or sound pressure level in the SIT group or the PT group posttreatment. Articulation rate increased in both treatment groups, although not differentially across treatments. Conclusions Findings from this first treatment study on intelligibility in francophone children with dysarthria suggest that SIT shows promise for increasing narrative intelligibility in this population. Acoustic contributors to the increased intelligibility remain to be explored further. Supplemental Material https://doi.org/10.23641/asha.14161943.

Intervention bimanual stimulates the abilities in infants with asymmetry

Abstract Introduction: The cerebral palsy and brachial plexus injury may cause asymmetry in the use of the upper limbs (UL). This condition requires early treatment to reduce the impact of the child's life; therefore, several proposed interventions aim to increase their functional independence. The Constraint-Induced Movement Therapy (CIMT) and Hand-Arm Bimanual Intensive Therapy (HABIT) have been widely considered effective interventions to improve hand function. Objective: Investigate the effects of an intervention protocol based on the CIMT and HABIT theoretical foundations in the stimulation of manual function in infants with the UL asymmetry. Methods: Five infants (6-24 months) participated in the study. To evaluate the motor function of infants we used Pediatric Motor Activity Log (PMAL-R) and Manual Function Evaluation (AMIGO), and to assess the caregiver's perception of the participation of the infant in daily tasks, we used the Pediatric Disability Assessment Inventory (PEDI). All evaluations occurred before, immediately after the intervention, and after four months for follow-up recording, and were analyzed descriptively by Jacobson- Truax method. Results: The results between evaluation and reevaluation demonstrated evolution in all aspects studied. In the PEDI self-care session, an average of 38.6 (±8.4) - 44.2 (±7.4); PEDI Mobility: 28.8 (±20.3) - 36.28 (±21.7); PEDI Social Function: 40.1 (±10.2) - 42.3 (±8.9). The PMAL-R quantity and quality results evidence a highly positive clinical significance in all infants. Conclusion: The application of the modified restriction intervention protocol resulted in reliable and clinically significant changes in all cases.

Identifying mechanisms of change in a magic-themed hand-arm bimanual intensive therapy programme for children with unilateral spastic cerebral palsy: a qualitative study using behaviour change theory

BackgroundThere has been much research into how to promote upper-limb skills to achieve functional independence in children with unilateral spastic cerebral palsy (USCP). One researched intervention is the Breathe Magic programme, which follows the protocol of hand-arm bimanual intensive therapy (HABIT) whilst, incorporating magic tricks to develop children’s motor skills and bimanual skills. However, whilst research has found the programme to be effective, there has been little consideration of how the intervention leads to a positive outcome: what the psychological, social and physical mechanisms of action are.MethodsQualitative semi-structured interviews with 21 children with USCP who participated in the Breathe Magic HABIT intervention, and focus groups with 17 parents and/or carers were undertaken. Analysis was conducted through the lens of the COM-B behaviour change model using a combined deductive framework and inductive thematic analysis. Reliability of coding was confirmed through random extraction and double coding of a portion of responses and the calculation of inter-rater reliability.ResultsBreathe Magic brings about change and positive outcomes by increasing children’s psychological and physical capabilities, providing social opportunities, and enhancing reflective and automatic motivation. Additionally, a number of enablers to engaging in the intervention were identified, particularly under psychological capabilities, social opportunities and both reflective and automatic motivation. Very few barriers were raised; those that were raised were of relatively low frequency of reporting.ConclusionsBy conducting a theory-based qualitative process evaluation, this study demonstrated the mechanisms of change behind the Breathe Magic HABIT intervention for children with USCP. Breathe Magic was found to be a well-structured combination of intended and unintended mechanisms of change. Overall, the success of Breathe Magic was observed through not only its intended mechanisms to enhance hand skills, but also through unintended psychological improvements in children’s hand function, as well as social and motivational benefits resulting from interaction between children and parents.

Hand-arm bimanual intensive therapy and daily functioning of children with bilateral cerebral palsy: a randomized controlled trial.

To examine the efficacy of Hand-Arm Bimanual Intensive Therapy (HABIT) on daily functioning, unimanual dexterity, and bimanual performance of children with bilateral cerebral palsy (CP) compared with customary care. Forty-one children with bilateral CP, aged 4 to 16 years, classified in levels I to III of the Manual Ability Classification System, were randomly assigned to HABIT (90h) (n=21) or to customary care (4.5h) (n=20). Participants' daily functioning (Pediatric Evaluation of Disability Inventory [PEDI], Canadian Occupational Performance Measure [COPM]), unimanual dexterity (Jebsen-Taylor Test of Hand Function, Box and Blocks Test [BBT]), and bimanual performance (Both Hands Assessment) were assessed pre-, post-, and 6months after the intervention. Linear mixed-effects models were used for inferential analysis. Children participating in HABIT showed greater improvements in daily functioning (COPMperformance : =9.50, p<0.01; COPMsatisfaction : =5.07, p<0.05; PEDIfunctional skills : =6.81, p<0.01; PEDIcaregiver assistance : =6.23, p<0.05) and in the dexterity of the dominant hand (BBT: =3.99, p<0.05) compared with children maintaining customary care. Group or time effects did not explain any variance in bimanual performance or in the dexterity of the non-dominant hand. HABIT may be beneficial for children with bilateral CP, with benefits evidenced for daily functioning outcomes. Hand-Arm Bimanual Intensive Therapy (HABIT) improved daily functioning of children with bilateral cerebral palsy (CP). Bimanual performance, measured by the Both Hands Assessment, did not change after HABIT in children with bilateral CP. Children with asymmetric and symmetric hand use exhibited similar improvements after HABIT.

Intensive upper extremity training improved whole body movement control for children with unilateral spastic cerebral palsy

BackgroundChildren with unilateral spastic cerebral palsy (USCP) exhibit impaired bimanual coordination, gait control, and whole body movement control. Intensive upper extremity training has been found to be effective for improving upper extremity function. However, the effectiveness of the intensive upper extremity training on whole body movement control is not known. Research questionThe present study aimed to evaluate the effects of Constraint Induced Movement Therapy (CIMT) and Hand Arm Bimanual Intensive Therapy (HABIT) on bimanual coordination and gait control during a complex whole body task. MethodsSixteen children with congenital hemiplegia (age 6–12 years; GMFCS: I-II, MACS: I-II) were randomly assigned to either CIMT or HABIT for 6 h per day training for 15 days. Children were asked to perform two whole body tasks (walking with and without a tray carrying) while 3-D kinematic analysis was performed before and after training. ResultsAfter training, the HABIT group increased the symmetry in height of their hands during tray carrying (more leveled tray). Both CIMT and HABIT groups decreased the lateral motion of the tray. The CIMT group increased speed and stride length after training in both the walking and tray carrying tasks. Both groups also increased their minimum toe clearance (all p < 0.05). SignificanceTwo types of intensive upper extremity training have provided significant improvements to whole body movement control for children with USCP. Adhering to the specificity of practice concept, HABIT improved bimanual coordination after training during the whole body tray carrying tasks. Given extensive interactions between the upper and lower extremities in real-world activities, future studies should focus on the effects of such combined training.

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

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 60 months of age, comparing the effect of 50 h (2 weeks) 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 3 months 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.