Dataset Information

Changes Induced by Early Hand-Arm Bimanual Intensive Therapy Including Lower Extremities in Young Children With Unilateral Cerebral Palsy: A Randomized Clinical Trial.

ABSTRACT:

Importance

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.

Objective

To verify if HABIT-ILE would improve manual abilities in young children with UCP more than usual motor activity.

Design, setting, and participants

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.

Interventions

Two weeks of usual motor activity including usual rehabilitation (control group) vs 2 weeks (50 hours) of HABIT-ILE (HABIT-ILE group).

Main outcomes and measures

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).

Results

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.

Conclusions and relevance

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.

Trial registration

ClinicalTrials.gov Identifier: NCT04020354.

SUBMITTER: Araneda R

PROVIDER: S-EPMC10628844 | biostudies-literature | 2024 Jan

REPOSITORIES: biostudies-literature

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Changes Induced by Early Hand-Arm Bimanual Intensive Therapy Including Lower Extremities in Young Children With Unilateral Cerebral Palsy: A Randomized Clinical Trial.

Araneda Rodrigo R Ebner-Karestinos Daniela D Paradis Julie J Klöcker Anne A Saussez Geoffroy G Demas Josselin J Bailly Rodolphe R Bouvier Sandra S Carton de Tournai Astrid A Herman Enimie E Souki Aghiles A Le Gal Grégoire G Nowak Emmanuel E Sizonenko Stephane V SV Newman Christopher J CJ Dinomais Mickael M Riquelme Inmaculada I Guzzetta Andrea A Brochard Sylvain S Bleyenheuft Yannick Y

JAMA pediatrics 20240101 1

<h4>Importance</h4>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.<h4>Objective</h4>To verify if HABIT-ILE would improve manual abilities in young children with UCP more than usual motor acti ...[more]

PMID: 37930692

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Project description:ImportanceEarlier detection of cerebral palsy (CP) and the high neuroplastic potential during the first years of life have motivated a search for early interventions to improve children's long-term motor abilities.ObjectiveTo determine the effectiveness of baby Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) to improve motor function in infants with unilateral CP (UCP).Design, setting, and participantsThis parallel group, 1:1, randomized clinical trial was conducted between December 1, 2020, and September 9, 2022, in infants recruited through centers specializing in CP treatment and parents' spontaneous applications. Therapy took place in Brussels, Belgium, from March 8, 2021, through June 17, 2022. Infants were matched in pairs by age and lesion type and randomized to either the treatment or control group. Infants were assessed at baseline (T0) and 1 (T1) and 3 months (T2) follow-up. Inclusion criteria were aged 6 to 18 months at T0 (corrected age if preterm birth), a diagnosis or being at risk of UCP, and the ability to comply with the testing and training procedures. Exclusion criteria were uncontrolled seizures, botulinum toxin injections, orthopedic surgery, or specific intensive therapy within 6 months before and until the end of the study.InterventionInfants in the treatment group received 50 hours of baby HABIT-ILE over 2 weeks, while those in the control group continued their usual motor activities.Main outcomes and measuresThe primary outcome was use of the more affected hand as measured using the Mini-Assisting Hand Assessment (Mini-AHA). Secondary outcomes included Canadian Occupational Performance Measure (COPM) performance and satisfaction scores, Gross Motor Function Measure-66 (GMFM-66) scores, and other motor and functional outcomes. Between-group comparisons were calculated using repeated-measures analysis of variance (2 groups × 3 assessment times). Effect sizes were reported as partial η squared (ηp2) (small, 0.01; medium, 0.06; large, 0.14).ResultsOf the 48 infants entering the study, 46 (mean [SD] age, 13.3 [4.1] months; 27 boys [58%]) were included in the final analyses, with 24 in the treatment group and 22 in the control group. Group × assessment time interactions showed significant improvements that favored the treatment group for the Mini-AHA (mean [SE] difference from T0 to T2, 7.4 [1.4] Mini-AHA units in the treatment group vs 1.9 [1.5] Mini-AHA units in the control group; P = .008; ƞp2 = 0.11) and for both parts of the COPM (mean [SE] difference from T0 to T2, 5.0 [0.4] in the treatment group vs 2.9 [0.4] in the control group; P < .001; ƞp2 = 0.35 for the performance score and 4.4 [0.4] in the treatment group vs 2.1 [0.4] in the control group; P < .001; ƞp2 = 0.33 for the satisfaction score). Although both groups improved in the GMFM-66 (mean [SE] difference from T0 to T2, 6.6% [0.7%] logits in the treatment group vs 5.5% [0.7%] logits in the control group; P < .001; ηp2 = 0.68), there was no significant interaction (P = .43; ηp2 = 0.02).Conclusions and relevanceThis randomized clinical trial demonstrates the feasibility of delivering 50 hours of HABIT-ILE over a 2-week period in infants with UCP. These findings show that the intervention is effective in improving motor abilities, as revealed by an increase in the use of the more affected hand in bimanual tasks and in enhanced reported functional goal outcomes.Trial registrationClinicalTrials.gov Identifier: NCT04698395.

Project description:IntroductionCerebral palsy (CP) is a paediatric disorder with permanent impairment of movement and posture with a prevalence of about 2.11 in 1000 births in the world. Given the therapeutic effect of hand-arm bimanual intensive therapy including lower extremities (HABIT-ILE) in children with CP, a systematic review of the available literature on this topic is warranted. The objective of this study is to systematically review the effectiveness of HABIT-ILE on upper extremity, lower extremity and trunk outcomes within the domains of body functions and structures, activity and participation of the International Classification of Functioning, Disability and Health in children with CP.Methods and analysisThis study will be conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Searches will be conducted in six databases: MEDLINE, PubMed, Cochrane Library, Scopus, OT seeker and Web of Science for available published literature. The grey literature sources will include WorldCat, National Technical Information Service, Agency for Healthcare Research and Quality, Open Grey, WHO and OpenDOAR. Manual searches of citations of included papers will be performed to collect all experimental studies of HABIT-ILE in children with CP. The level of evidence for included articles will be classified according to the level of evidence in the guidelines for systematic reviews on the American Occupational Therapy Association website. Based on the study design of the included articles, the risk of bias will be assessed using the revised Cochrane risk-of-bias tool, the Cochrane Risk Of Bias In Non-randomised Studies - of Interventions tool and the quality assessment tool recommended by the American Occupational Therapy Association. In order to synthesise the data, narrative synthesis will be used, along with meta-analysis, if available.Ethics and disseminationAs this study only reviewed previously published articles, ethical approval was not required. The findings will be published in a peer-reviewed scientific journal.Prospero registration numberCRD42024518179.

Project description: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.

Project description:Hand-arm bimanual intensive therapy (HABIT) enhances upper extremity (UE) function and bimanual coordination in children with unilateral cerebral palsy (UCP). Previous studies assessed immediate improvements in UE function using clinical and self-reported measures, which may not accurately reflect real-world UE performance and their long-term retention effects. Therefore, this study aims to investigate the retention of real-world bimanual performance gains over time following HABIT in children with UCP. Thirty children with UCP, age 6-16 years underwent HABIT (6 hours/day for 5 days). Bimanual performance was assessed using GT9X Link accelerometers, worn on bilateral wrists for 3 days pre-, post-, 3-, and 6-month of HABIT. Accelerometer-derived variables-use ratio (UR), magnitude ratio (MR), bilateral magnitude (BM), median acceleration (MA), and acceleration variability (AV)-quantified bimanual performance during real-world activities. UE function was measured with standardized assessments. A mixed model analysis with repeated measures and paired t-tests analyzed the differences real-world bimanual performance and UE function respectively. There was a significant main effect of time in UR (F = 2.72, p = 0.05), BM (F = 4.36, p = 0.007), and MA (F = 3.68, p = 0.016). Post-hoc analysis (mean differences, 95% confidence interval [CI]) revealed improvements immediately post- compared to pre-HABIT in BM (14.99, 4.35-25.63) and MA (7.46, 2.55-12.36). However, subsequent assessments at 3- and 6-months displayed a regression in these gains, suggesting a lack of retention. A decline was observed at 3 months) and 6 months (BM; 16.94, 6.3-27.4, MA; 6.51, 1.61-11.41) in BM and MA compared to post-HABIT. UE capacity measures also showed improvements (p < 0.05) post-HABIT. Although HABIT initially may enhance performance of real-world bimanual tasks, its benefits diminish within six months, suggesting a need for repeating HABIT every 3-6 months to retain long-term improvements.

Project description: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 registrationNCT04017871 REGISTRATION DATE: July 12, 2019.

Project description: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 been widely recommended to use goal-oriented interventions with a high amount of task-specific repetitions. These interventions are generally focused only on the upper or lower extremities separately, despite the impairments are observed at the whole-body level and ADL are both frequently bimanual and may require moving around. This highlights the need for interventions targeting both upper and lower extremities. This protocol presents the first adaptation of Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) for adults with acquired hemiparesis.Methods and analysisThis randomised controlled trial will include 48 adults with chronic stroke, aged ≥40 years. This study will compare the effect of 50 hours of HABIT-ILE against usual motor activity and regular rehabilitation. HABIT-ILE will be provided in a 2-week, adult's day-camp setting, promoting functional tasks and structured activities. These tasks will continuously progress by increasing their difficulty. Assessed at baseline, 3 weeks after and at 3 months, the primary outcome will be the adults-assisting-hand-assessment stroke; secondary outcomes include behavioural assessments for hand strength and dexterity, a motor learning robotic medical device for quality of bimanual motor control, walking endurance, questionnaires of ADL, stroke impact on participation and self-determined patient-relevant goals, besides neuroimaging measures.Ethics and disseminationThis study has full ethical approval from the Comité d'éthique Hospitalo-Facultaire/Université catholique de Louvain, Brussels (reference number: 2013/01MAR/069) and the local medical Ethical Committee of the CHU UCL Namur-site Godinne. Recommendations of the ethical board and the Belgian law of 7 May 2004, concerning human experiments will be followed. Participants will sign a written informed consent ahead of participation. Findings will be published in peer-reviewed journals and conference presentations.Trial registration numberNCT04664673.

Project description:IntroductionChildren with bilateral cerebral palsy often experience difficulties with posture, gross motor function and manual ability, impacting independence in daily life activities, participation and quality of life (QOL). Hand-Arm Bimanual Intensive Training Including Lower Extremity (HABIT-ILE) is a novel intensive motor intervention integrating upper and lower extremity training. This study aimed to compare HABIT-ILE to usual care in a large randomised controlled trial (RCT) in terms of gross motor function, manual ability, goal attainment, walking endurance, mobility, self-care and QOL. A within-trial cost-utility analysis will be conducted to synthesise costs and benefits of HABIT-ILE compared with usual care.Methods and analysis126 children with bilateral cerebral palsy aged 6-16 years will be recruited across three sites in Australia. Children will be stratified by site and Gross Motor Function Classification System and randomised using concealed allocation to either receiving HABIT-ILE immediately or being waitlisted for 26 weeks. HABIT-ILE will be delivered in groups of 8-12 children, for 6.5 hours per day for 10 days (total 65 hours, 2 weeks). Outcomes will be assessed at baseline, immediately following intervention, and then retention of effects will be tested at 26 weeks. Primary outcomes will be the Gross Motor Function Measure and ABILHAND-Kids. Secondary outcomes will be brain structural integrity, walking endurance, bimanual hand performance, self-care, mobility, performance and satisfaction with individualised goals, and QOL. Analyses will follow standard principles for RCTs using two-group comparisons on all participants on an intention-to-treat basis. Comparisons between groups for primary and secondary outcomes will be conducted using regression models.Ethics and disseminationEthics approval has been granted by the Medical Research Ethics Committee of Children's Health Queensland Hospital and the Health Service Human Research Ethics Committee (HREC/17/QRCH/282) of The University of Queensland (2018000017/HREC/17/QRCH/2820), and The Cerebral Palsy Alliance Ethics Committee (2018_04_01/HREC/17/QRCH/282).Trial registration numberACTRN12618000164291.

Project description:IntroductionCerebral palsy (CP) is highly prevalent in sub-Saharan Africa, where clinically-based studies have shown a considerable over-representation of the severe bilateral subtype. However, children's access to rehabilitation care is limited by many local factors, notably the lacking of rehabilitation services, insufficient knowledge of caregivers and financial constraints. In such a context there is an urgent need for studies of the evidence-based rehabilitation approach. Here, we describe the protocol of a randomised controlled study to investigate the efficacy of Hand-Arm Bimanual Intensive Therapy Including the Lower Extremities (HABIT-ILE) in young children with bilateral CP in Benin Republic, a representative low and middle-income country of western Africa.Methods and analysisForty children with bilateral CP aged between 24 and 59 months and with level III-IV in the gross motor function classification will be randomised to either a high intensity conventional therapy or HABIT-ILE therapy. Both therapies will be delivered as a day-camp model over 2 weeks to a total of 50 hours (5 hours per day). The assessor-blinded primary outcomes will include the gross motor function measure and both hands assessment. Secondary outcomes will be the adapted version of the ACTIVLIM-CP questionnaire, the Canadian Occupational Performance Measure, and a perception of CP interview form. Children will be assessed at baseline, after intervention and at 6-week follow-up. A 2 (group)×3 (test sessions) repeated analysis of variance will evaluate changes after the interventions.Ethics and disseminationThis study has been approved by the ethics committee of the rehabilitation department of the National Teaching Hospital Hubert Koutoukou Maga of Cotonou, Benin (approval decision: N°01-2019/MS/CNHU-HKM/CEI/CUMPR). All participants' parents/caregivers will provide their written informed consent. Data will be managed with confidentiality.Trial registration numberPACTR201911894444879.

Project description:Hand-Arm Bimanual Intensive Therapy (HABIT) promotes hand function using intensive practice of bimanual functional and play tasks. This intervention has shown to be efficacious to improve upper-extremity (UE) function in children with unilateral spastic cerebral palsy (USCP). In addition to UE function deficits, lower-extremity (LE) function and UE-LE coordination are also impaired in children with USCP. Recently, a new intervention has been introduced in which the LE is simultaneously engaged during HABIT (Hand-Arm Bimanual Intensive Therapy Including Lower Extremities; HABIT-ILE). Positive effects of this therapy have been demonstrated for both the UE and LE function in children with USCP. However, it is unknown whether the addition of this constant LE component during a bimanual intensive therapy attenuates UE improvements observed in children with USCP. This retrospective study, based on multiple randomized protocols, aims to compare the UE function improvements in children with USCP after HABIT or HABIT-ILE. This study included 86 children with USCP who received 90 h of either HABIT (n = 42) or HABIT-ILE (n = 44) as participants in previous studies. Children were assessed before, after, and 4-6 months after intervention. Primary outcomes were the ABILHAND-Kids and the Assisting Hand Assessment. Secondary measures included the Jebsen-Taylor Test of Hand Function, the Pediatric Evaluation of Disability Inventory [(PEDI); only the self-care functional ability domain] and the Canadian Occupational Performance Measure (COPM). Data analysis was performed using two-way repeated-measures analysis of variance with repeated measures on test sessions. Both groups showed similar, significant improvements for all tests (test session effect p < 0.001; group × test session interaction p > 0.05) except the PEDI and COPM. Larger improvements on these tests were found for the HABIT-ILE group (test session effect p < 0.001; group × test session interaction p < 0.05). These larger improvements may be explained by the constant simultaneous UE-LE engagement observed during the HABIT-ILE intervention since many daily living activities included in the PEDI and the COPM goals involve the LE and, more specifically, UE-LE coordination. We conclude that UE improvements in children with USCP are not attenuated by simultaneous UE-LE engagement during intensive intervention. In addition, systematic LE engagement during bimanual intensive intervention (HABIT-ILE) leads to larger functional improvements in activities of daily living involving the LE.

Dataset Information

Changes Induced by Early Hand-Arm Bimanual Intensive Therapy Including Lower Extremities in Young Children With Unilateral Cerebral Palsy: A Randomized Clinical Trial.

Importance

Objective

Design, setting, and participants

Interventions

Main outcomes and measures

Results

Conclusions and relevance

Trial registration

Publications

Changes Induced by Early Hand-Arm Bimanual Intensive Therapy Including Lower Extremities in Young Children With Unilateral Cerebral Palsy: A Randomized Clinical Trial.

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