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Combining constraint-induced movement therapy and action-observation training in children with unilateral cerebral palsy: a randomized controlled trial.

ABSTRACT: Upper limb (UL) deficits in children with unilateral cerebral palsy (uCP) have traditionally been targeted with motor execution treatment models, such as modified Constraint-Induced Movement Therapy (mCIMT). However, new approaches based on a neurophysiological model such as Action-Observation Training (AOT) may provide new opportunities for enhanced motor learning. The aim of this study is to describe a randomised controlled trial (RCT) protocol investigating the effects of an intensive treatment model, combining mCIMT and AOT compared to mCIMT alone on UL function in children with uCP. Additionally, the role of neurological factors as potential biomarkers of treatment response will be analysed.An evaluator-blinded RCT will be conducted in 42 children aged between 6 and 12 years. Before randomization, children will be stratified according to their House Functional Classification Scale, age and type of corticospinal tract wiring. A 2-week day-camp will be set up in which children receive intensive mCIMT therapy for 6 hours a day on 9 out of 11 consecutive days (54 h) including AOT or control condition (15 h). During AOT, these children watch video sequences showing goal-directed actions and subsequently execute the observed actions with the more impaired UL. The control group performs the same actions after watching computer games without human motion. The primary outcome measure will be the Assisting Hand Assessment. Secondary outcomes comprise clinical assessments across body function, activity and participation level of the International Classification of Function, Disability and Health. Furthermore, to quantitatively evaluate UL movement patterns, a three-dimensional motion analysis will be conducted. UL function will be assessed at baseline, immediately before and after intervention and at 6 months follow up. Brain imaging comprising structural and functional connectivity measures as well as Transcranial Magnetic Stimulation (TMS) to evaluate corticospinal tract wiring will be acquired before the intervention.This paper describes the methodology of an RCT with two main objectives: (1) to evaluate the added value of AOT to mCIMT on UL outcome in children with uCP and (2) to investigate the role of neurological factors as potential biomarkers of treatment response.NCT03256357 registered on 21st August 2017 (retrospectively registered).

SUBMITTER: Simon-Martinez C

PROVIDER: S-EPMC6069849 | biostudies-other | 2018 Jul

REPOSITORIES: biostudies-other

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Combining constraint-induced movement therapy and action-observation training in children with unilateral cerebral palsy: a randomized controlled trial.

Simon-Martinez Cristina C Mailleux Lisa L Ortibus Els E Fehrenbach Anna A Sgandurra Giuseppina G Cioni Giovanni G Desloovere Kaat K Wenderoth Nicole N Demaerel Philippe P Sunaert Stefan S Molenaers Guy G Feys Hilde H Klingels Katrijn K

BMC pediatrics 20180731 1

<h4>Background</h4>Upper limb (UL) deficits in children with unilateral cerebral palsy (uCP) have traditionally been targeted with motor execution treatment models, such as modified Constraint-Induced Movement Therapy (mCIMT). However, new approaches based on a neurophysiological model such as Action-Observation Training (AOT) may provide new opportunities for enhanced motor learning. The aim of this study is to describe a randomised controlled trial (RCT) protocol investigating the effects of a ...[more]

PMID: 30064396

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Project description:IntroductionConstraint-induced movement therapy (CIMT) improves upper limb (UL) motor execution in unilateral cerebral palsy (uCP). As these children also show motor planning deficits, action-observation training (AOT) might be of additional value. Here, we investigated the combined effect of AOT to CIMT and identified factors influencing treatment response.MethodsA total of 44 children with uCP (mean 9 years 6 months, SD 1 year 10 months) participated in a 9-day camp wearing a splint for 6 h/day and were allocated to the CIMT + AOT (n = 22) and the CIMT + placebo group (n = 22). The CIMT + AOT group received 15 h of AOT (i.e. video-observation) and executed the observed tasks, whilst the CIMT + AOT group watched videos free of biological motion and executed the same tasks. The primary outcome measure was bimanual performance. Secondary outcomes included measures of body function and activity level assessed before (T1), after the intervention (T2), and at 6 months follow-up (T3). Influencing factors included behavioural and neurological characteristics.ResultsAlthough no between-groups differences were found (p > 0.05; η2 = 0-16), the addition of AOT led to higher gains in children with initially poorer bimanual performance (p = 0.02; η2 = 0.14). Both groups improved in all outcome measures after the intervention and retained the gains at follow up (p < 0.01; η2 = 0.02-0.71). Poor sensory function resulted in larger improvements in the total group (p = 0.03; η2 = 0.25) and high amounts of mirror movements tended to result in a better response to the additional AOT training (p = 0.06; η2 = 0.18). Improvements were similar irrespective of the type of brain lesion or corticospinal tract wiring pattern.ConclusionsAdding AOT to CIMT, resulted in a better outcome for children with poor motor function and high amounts of mirror movements. CIMT with or without AOT seems to be more beneficial for children with poor sensory function.Trial registrationRegistered at ClinicalTrials.gov on 22nd August 2017 (ClinicalTrials.gov identifier: NCT03256357).

Project description:Unilateral Cerebral Palsy (UCP), the most frequent form of Cerebral Palsy, usually affects more the upper limb (UL) than the lower limb. Rehabilitation programs are addressed to improve manual abilities and UL use. In recent years, Information and Communication Technology (ICT) has been introduced in rehabilitation to increase treatment opportunities for patients, and also in home-based intervention. Moreover, the discovery of the Mirror Neuron System allowed to insert a new paradigm of treatment that is the Action Observation Training (AOT). The aim of the present study was to investigate the feasibility of a new rehabilitative home-based approach, called Tele-UPCAT (Tele-monitored UPper Limb Children Action Observation Training), based on the principles of AOT, in a group of Italian children and adolescents with UCP. This investigation was to provide information about the possibility of introducing ICT in telerehabilitation field. Twenty-nine children aged 11.73 ± 3.65 years (range 6.00-18.75) with a diagnosis of UCP participated in the study. They carried out 15 days of training based on the AOT paradigm with Tele-UPCAT system while wearing Actigraphs on both wrists. The feasibility of both training and study design and procedures was assessed through nine criteria taken from existent literature and from a questionnaire designed and realized ad hoc for the purpose, based on standard items of usability and acceptability. All feasibility criteria were met: 80% of training sessions were completed in the planned time and no significant technical issues were found. From the questionnaire, total scores were all above 82.15%, while the four sections obtained the following scores: (i) customization of exercises 80.00%; (ii) acceptability at home, 77.50%; (iii) required effort 80.00%; and (iv) suitability of manual and software 95.00%. No differences were found for age and sex. Tele-UPCAT demonstrated to be feasible as a home-based AOT for children and adolescents with UCP. Trial registration NCT03094455.

Project description:Rehabilitation for children with hemiplegic cerebral palsy (HCP) aimed to improve function of the impaired upper limb (UL) uses a wide range of intervention programs. A new rehabilitative approach, called Action-Observation Therapy, based on the recent discovery of mirror neurons, has been used in adult stroke but not in children. The purpose of the present study is to design a randomised controlled trial (RCT) for evaluating the efficacy of Action-Observation Therapy in improving UL activity in children with HCP.The trial is designed according to CONSORT Statement. It is a randomised, evaluator-blinded, match-pair group trial. Children with HCP will be randomised within pairs to either experimental or control group. The experimental group will perform an Action-Observation Therapy, called UP-CAT (Upper Limb-Children Action-Observation Training) in which they will watch video sequences showing goal-directed actions, chosen according to children UL functional level, combined with motor training with their hemiplegic UL. The control group will perform the same tailored actions after watching computer games. A careful revision of psychometric properties of UL outcome measures for children with hemiplegia was performed. Assisting Hand Assessment was chosen as primary measure and, based on its calculation power, a sample size of 12 matched pairs was established. Moreover, Melbourne and ABILHAND-Kids were included as secondary measures. The time line of assessments will be T0 (in the week preceding the onset of the treatment), T1 and T2 (in the week after the end of the treatment and 8 weeks later, respectively). A further assessment will be performed at T3 (24 weeks after T1), to evaluate the retention of effects. In a subgroup of children enrolled in both groups functional Magnetic Resonance Imaging, exploring the mirror system and sensory-motor function, will be performed at T0, T1 and T2.The paper aims to describe the methodology of a RCT for evaluating the efficacy of Action-Observation Therapy in improving UL activity in children with hemiplegia. This study will be the first to test this new type of treatment in childhood. The paper presents the theoretical background, study hypotheses, outcome measures and trial methodology.NCT01016496.

Dataset Information

Combining constraint-induced movement therapy and action-observation training in children with unilateral cerebral palsy: a randomized controlled trial.

Publications

Combining constraint-induced movement therapy and action-observation training in children with unilateral cerebral palsy: a randomized controlled trial.

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