Dataset Information

UP-BEAT (Upper Limb Baby Early Action-observation Training): protocol of two parallel randomised controlled trials of action-observation training for typically developing infants and infants with asymmetric brain lesions.

ABSTRACT:

Introduction

Infants with asymmetric brain lesions are at high risk of developing congenital hemiplegia. Action-observation training (AOT) has been shown to effectively improve upper limb motor function in adults with chronic stroke. AOT is based on action observation, whereby new motor skills can be learnt by observing motor actions. This process is facilitated by the Mirror Neuron System, which matches observed and performed motor actions. This study aims to determine the efficacy of AOT in: (1) influencing the early development of reaching and grasping of typically developing infants and (2) improving the upper limb activity of infants with asymmetric brain lesions.

Methods and analysis

This study design comprises two parallel randomised sham-controlled trials (RCTs) in: (1) typically developing infants (cohort I) and (2) infants with asymmetric brain lesions (eg, arterial stroke, venous infarction, intraventricular haemorrhage or periventricular leukomalacia; cohort II). Cohort II will be identified through a neonatal ultrasound or neonatal MRI. A sham control will be used for both RCTs, taking into consideration that it would be unethical to give no intervention to an at-risk population. Based on a two-tailed t test of two independent means, with a significance (?) level of 0.05, 80% power, predicted effect size of 0.8 and a 90% retention rate, we require 20 participants in each group (total sample of 40) for cohort I. The sample size for cohort II was based on the assumption that the effect size of the proposed training would be similar to that found by Heathcock et al in preterm born infants (n=26) with a mean effect size of 2.4. Given the high effect size, the calculation returned a sample of only four participants per group, on a two-tailed t test, with a significance (?) level of 0.05 and 80% power. As cohort II will consist of two subgroups of lesion type (ie, arterial stroke and venous infarction), we have quadrupled the sample to include 16 participants in each group (total sample of 32). Infants will be randomised to receive either AOT or standard Toy Observation Training (TOT). Both interventions will be of 4 weeks' duration, from the infant's 9th-13th post-term week of age. Three sessions of 5 min each will be performed each day for 6 days/week (total of 6 h over 28 days). Parents of the AOT group will repeatedly show the infant a grasping action on a set of three toys, presented in random order. Parents of the TOT group will show the infant the same set of three toys, in random order, without demonstrating the grasping action. At 14, 16 and 18 weeks, the quantity and quality of reaching and grasping will be measured using the Grasping and Reaching Assessment of Brisbane; symmetry of reaching and grasping will be measured using the Hand Assessment of Infants (HAI) and pressure of grasping for each hand with a customised pressure sensor. At 6 months' corrected age, the primary outcome measures will be the HAI and Bayley Scales of Infant and Toddler Development (third edition; BSID III), to measure cognitive and motor development. At 8 months, HAI and EEG will be used to measure brain activity and cortical coherence. At 12 months, the primary outcome measures will again be HAI and BSID III.

Dissemination

This paper outlines the theoretical basis, study hypotheses and outcome measures for two parallel RCTs comparing the novel intervention Action-observation training with standard TOT in: (1) influencing the early development of reaching and grasping of typically developing infants and (2) improving the upper limb motor activity of infants with asymmetric brain lesions.

Trial registration

ACTRN1261100991910. Web address of trial http://www.ANZCTR.org.au/ACTRN12611000991910.aspx.

SUBMITTER: Guzzetta A

PROVIDER: S-EPMC3586152 | biostudies-literature | 2013

REPOSITORIES: biostudies-literature

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Project description:BackgroundAction observation (AO) is a physical rehabilitation approach that facilitates the occurrence of neural plasticity through the activation of the mirror-neural system, promoting motor recovery in people with stroke.ObjectivesTo assess whether AO enhances upper limb motor function in people with stroke.Search methodsWe searched the Cochrane Stroke Group Trials Register (last searched 18 May 2021), the Cochrane Central Register of Controlled Trials (18 May 2021), MEDLINE (1946 to 18 May 2021), Embase (1974 to 18 May 2021), and five additional databases. We also searched trial registries and reference lists.Selection criteriaRandomized controlled trials (RCTs) of AO alone or associated with physical practice in adults after stroke. The primary outcome was upper limb (arm and hand) motor function. Secondary outcomes included dependence on activities of daily living (ADL), motor performance, cortical activation, quality of life, and adverse effects.Data collection and analysisTwo review authors independently selected trials according to the predefined inclusion criteria, extracted data, assessed risk of bias using RoB 1, and applied the GRADE approach to assess the certainty of the evidence. The reviews authors contacted trial authors for clarification and missing information.Main resultsWe included 16 trials involving 574 individuals. Most trials provided AO followed by the practice of motor actions. Training varied between 1 day and 8 weeks of therapy, 10 to 90 minutes per session. The time of AO ranged from 1 minute to 10 minutes for each motor action, task or movement observed. The total number of motor actions ranged from 1 to 3. Control comparisons included sham observation, physical therapy, and functional activity practice.Primary outcomesAO improved arm function (standardized mean difference (SMD) 0.39, 95% confidence interval (CI) 0.17 to 0.61; 11 trials, 373 participants; low-certainty evidence); and improved hand function (mean difference (MD) 2.76, 95% CI 1.04 to 4.49; 5 trials, 178 participants; low-certainty evidence).Secondary outcomesAO did not improve ADL performance (SMD 0.37, 95% CI -0.34 to 1.08; 7 trials, 302 participants; very low-certainty evidence), or quality of life (MD 5.52, 95% CI -30.74 to 41.78; 2 trials, 30 participants; very low-certainty evidence). We were unable to pool the other secondary outcomes (motor performance and cortical activation). Only two trials reported adverse events without significant adverse effects.Authors' conclusionsThe effects of AO are small for arm function compared to any control group; for hand function the effects are large, but not clinically significant. For both, the certainty of evidence is low. There is no evidence of benefit or detriment from AO on ADL and quality of life of people with stroke; however, the certainty of evidence is very low. As such, our confidence in the effect estimate is limited because it will likely change with future research.

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.

Project description:BackgroundIn the last few years, new noninvasive strategies have emerged as rehabilitative treatments for patients with stroke. Action observation treatment (AOT) is a rehabilitation approach based on the properties of the mirror neuron system with a positive impact on modifying cortical activation patterns and improving the upper limb kinematics. AOT involves the dynamic process of observing purposeful actions with the intention of imitating and then practicing those actions. In recent years, several clinical studies suggested the effectiveness of AOT in patients with stroke to improve motor recovery and autonomy in activities of daily living. However, a deeper knowledge of the behavior of the sensorimotor cortex during AOT seems to be essential.ObjectiveThe aim of this clinical trial, conducted in 2 neurorehabilitation centers and in patients' homes, is to investigate the effectiveness of AOT in patients with stroke, confirming the translational power of a tailored treatment. Particular emphasis will be placed on the predictive value of neurophysiological biomarkers. In addition, the feasibility and impact of a home-based AOT program will be investigated.MethodsA 3-arm, assessor-blinded, randomized controlled trial will be performed by enrolling patients with stroke in the chronic stage. A total of 60 participants will be randomly allocated to receive 15 sessions of AOT with different protocols (AOT at the hospital, AOT at home, and sham AOT), 3 sessions per week. The primary outcome will be assessed using the Fugl-Meyer Assessment-Upper Extremity scores. Secondary outcomes will be clinical, biomechanical, and neurophysiological assessment.ResultsThe study protocol is part of a project (project code GR-2016-02361678) approved and funded by the Italian Ministry of Health. The study began with the recruitment phase in January 2022, and enrollment was expected to end in October 2022. Recruitment is now closed (December 2022). The results of this study are expected to be published in spring 2023. Upon completion of the analyses, we will examine the preliminary effectiveness of the intervention and neurophysiological outcomes.ConclusionsThis study will be used to evaluate the effectiveness of 2 different AOT scenarios (ie, AOT at the hospital and AOT at home) in patients with chronic stroke and to assess the predictive value of neurophysiological biomarkers. Specifically, we will attempt to induce the functional modification of the cortical components by exploiting the features of the mirror neuron system, demonstrating relevant clinical, kinematic, and neurophysiological changes after AOT. With our study, we also want to provide, for the first time in Italy, the AOT home-based program while assessing its feasibility and impact.Trial registrationClinicalTrials.gov NCT04047134; https://clinicaltrials.gov/ct2/show/NCT04047134.International registered report identifier (irrid)DERR1-10.2196/42094.