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Effects of action observation therapy and mirror therapy after stroke on rehabilitation outcomes and neural mechanisms by MEG: study protocol for a randomized controlled trial.

ABSTRACT: Loss of upper-extremity motor function is one of the most debilitating deficits following stroke. Two promising treatment approaches, action observation therapy (AOT) and mirror therapy (MT), aim to enhance motor learning and promote neural reorganization in patients through different afferent inputs and patterns of visual feedback. Both approaches involve different patterns of motor observation, imitation, and execution but share some similar neural bases of the mirror neuron system. AOT and MT used in stroke rehabilitation may confer differential benefits and neural activities that remain to be determined. This clinical trial aims to investigate and compare treatment effects and neural activity changes of AOT and MT with those of the control intervention in patients with subacute stroke.An estimated total of 90 patients with subacute stroke will be recruited for this study. All participants will be randomly assigned to receive AOT, MT, or control intervention for a 3-week training period (15 sessions). Outcome measurements will be taken at baseline, immediately after treatment, and at the 3-month follow-up. For the magnetoencephalography (MEG) study, we anticipate that we will recruit 12 to 15 patients per group. The primary outcome will be the Fugl-Meyer Assessment score. Secondary outcomes will include the modified Rankin Scale, the Box and Block Test, the ABILHAND questionnaire, the Questionnaire Upon Mental Imagery, the Functional Independence Measure, activity monitors, the Stroke Impact Scale version 3.0, and MEG signals.This clinical trial will provide scientific evidence of treatment effects on motor, functional outcomes, and neural activity mechanisms after AOT and MT in patients with subacute stroke. Further application and use of AOT and MT may include telerehabilitation or home-based rehabilitation through web-based or video teaching.ClinicalTrials.gov, ID: NCT02871700 . Registered on 1 August 2016.

SUBMITTER: Shih TY

PROVIDER: S-EPMC5628464 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature

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Effects of action observation therapy and mirror therapy after stroke on rehabilitation outcomes and neural mechanisms by MEG: study protocol for a randomized controlled trial.

Shih Tsai-Yu TY Wu Ching-Yi CY Lin Keh-Chung KC Cheng Chia-Hsiung CH Hsieh Yu-Wei YW Chen Chia-Ling CL Lai Chih-Jou CJ Chen Chih-Chi CC

Trials 20171004 1

<h4>Background</h4>Loss of upper-extremity motor function is one of the most debilitating deficits following stroke. Two promising treatment approaches, action observation therapy (AOT) and mirror therapy (MT), aim to enhance motor learning and promote neural reorganization in patients through different afferent inputs and patterns of visual feedback. Both approaches involve different patterns of motor observation, imitation, and execution but share some similar neural bases of the mirror neuron ...[more]

PMID: 28978349

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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: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.

Project description:BackgroundMotor (re)learning via technology-dependent therapy has the potential to complement traditional therapies available to older adults living with stroke after hospital discharge and increase therapy dose. To date, little is known about the feasibility of technology-dependent therapy in a home setting for this population.ObjectiveTo develop a technology-dependent therapy that provides mental and physical training for older adults with stroke and assess feasibility. Specifically we ask, "Can it work"?DesignSingle group repeated measures.Methods13 participants, aged 18 years and over, were recruited over a six-month period. All participants had mild upper limb impairment following a stoke and were no longer receiving intensive rehabilitation. All participants received 18 days of technology-dependent therapy in their own home. Information was gathered on recruitment and retention, usability, and suitability of outcome measures.Results11 participants completed the study. The recruitment rate (number recruited/number canvassed; 10.7%) suggests 1907 participants would need to be canvassed to recruit the necessary sample size (n = 204) for a definitive trial designed to provide 90% power at 5% level of significance to detect a clinically meaningful difference of 5.7 points on the Action Research Arm Test. The usability of the application was rated as exceptional on the System Usability Scale. Effectiveness cannot be determined from this study; however, there was a trend for improvement in measures of upper limb function and emotional well-being. Limitations. The study was limited by a relatively small sample size and lack of control group.ConclusionsThis study demonstrated proof of concept of a technology-dependent therapy for upper limb rehabilitation following stroke. The data suggest a definitive trial is feasible, additional strategies to improve recruitment should be considered. Outcome measures aligned with the residual motor function of participants are required.

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Effects of action observation therapy and mirror therapy after stroke on rehabilitation outcomes and neural mechanisms by MEG: study protocol for a randomized controlled trial.

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Effects of action observation therapy and mirror therapy after stroke on rehabilitation outcomes and neural mechanisms by MEG: study protocol for a randomized controlled trial.

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