Arm rehabilitation in post stroke subjects: A randomized controlled trial on the efficacy of myoelectrically driven FES applied in a task-oriented approach

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Abstract

Purpose

Motor recovery of persons after stroke may be enhanced by a novel approach where residual muscle activity is facilitated by patient-controlled electrical muscle activation. Myoelectric activity from hemiparetic muscles is then used for continuous control of functional electrical stimulation (MeCFES) of same or synergic muscles to promote restoration of movements during task-oriented therapy (TOT). Use of MeCFES during TOT may help to obtain a larger functional and neurological recovery than otherwise possible.

Study design

Multicenter randomized controlled trial.

Methods

Eighty two acute and chronic stroke victims were recruited through the collaborating facilities and after signing an informed consent were randomized to receive either the experimental (MeCFES assisted TOT (M-TOT) or conventional rehabilitation care including TOT (C-TOT). Both groups received 45 minutes of rehabilitation over 25 sessions. Outcomes were Action Research Arm Test (ARAT), Upper Extremity Fugl-Meyer Assessment (FMA-UE) scores and Disability of the Arm Shoulder and Hand questionnaire.

Results

Sixty eight subjects completed the protocol (Mean age 66.2, range 36.5–88.7, onset months 12.7, range 0.8–19.1) of which 45 were seen at follow up 5 weeks later. There were significant improvements in both groups on ARAT (median improvement: MeCFES TOT group 3.0; C-TOT group 2.0) and FMA-UE (median improvement: M-TOT 4.5; C-TOT 3.5). Considering subacute subjects (time since stroke < 6 months), there was a trend for a larger proportion of improved patients in the M-TOT group following rehabilitation (57.9%) than in the C-TOT group (33.2%) (difference in proportion improved 24.7%; 95% CI -4.0; 48.6), though the study did not meet the planned sample size.

Conclusion

This is the first large multicentre RCT to compare MeCFES assisted TOT with conventional care TOT for the upper extremity. No adverse events or negative outcomes were encountered, thus we conclude that MeCFES can be a safe adjunct to rehabilitation that could promote recovery of upper limb function in persons after stroke, particularly when applied in the subacute phase.

Related collections

Most cited references 35

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Effects of robot-assisted therapy on upper limb recovery after stroke: a systematic review.

Gert Kwakkel, Boudewijn J. Kollen, Hermano Krebs (2007)

The aim of the study was to present a systematic review of studies that investigate the effects of robot-assisted therapy on motor and functional recovery in patients with stroke. A database of articles published up to October 2006 was compiled using the following Medline key words: cerebral vascular accident, cerebral vascular disorders, stroke, paresis, hemiplegia, upper extremity, arm, and robot. References listed in relevant publications were also screened. Studies that satisfied the following selection criteria were included: (1) patients were diagnosed with cerebral vascular accident; (2) effects of robot-assisted therapy for the upper limb were investigated; (3) the outcome was measured in terms of motor and/or functional recovery of the upper paretic limb; and (4) the study was a randomized clinical trial (RCT). For each outcome measure, the estimated effect size (ES) and the summary effect size (SES) expressed in standard deviation units (SDU) were calculated for motor recovery and functional ability (activities of daily living [ADLs]) using fixed and random effect models. Ten studies, involving 218 patients, were included in the synthesis. Their methodological quality ranged from 4 to 8 on a (maximum) 10-point scale. Meta-analysis showed a nonsignificant heterogeneous SES in terms of upper limb motor recovery. Sensitivity analysis of studies involving only shoulder-elbow robotics subsequently demonstrated a significant homogeneous SES for motor recovery of the upper paretic limb. No significant SES was observed for functional ability (ADL). As a result of marked heterogeneity in studies between distal and proximal arm robotics, no overall significant effect in favor of robot-assisted therapy was found in the present meta-analysis. However, subsequent sensitivity analysis showed a significant improvement in upper limb motor function after stroke for upper arm robotics. No significant improvement was found in ADL function. However, the administered ADL scales in the reviewed studies fail to adequately reflect recovery of the paretic upper limb, whereas valid instruments that measure outcome of dexterity of the paretic arm and hand are mostly absent in selected studies. Future research into the effects of robot-assisted therapy should therefore distinguish between upper and lower robotics arm training and concentrate on kinematical analysis to differentiate between genuine upper limb motor recovery and functional recovery due to compensation strategies by proximal control of the trunk and upper limb.

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The intra- and interrater reliability of the action research arm test: a practical test of upper extremity function in patients with stroke.

J H Van der Lee, V De Groot, H Beckerman … (2001)

To determine the intra- and interrater reliability of the Action Research Arm (ARA) test, to assess its ability to detect a minimal clinically important difference (MCID) of 5.7 points, and to identify less reliable test items. Intrarater reliability of the sum scores and of individual items was assessed by comparing (1) the ratings of the laboratory measurements of 20 patients with the ratings of the same measurements recorded on videotape by the original rater, and (2) the repeated ratings of videotaped measurements by the same rater. Interrater reliability was assessed by comparing the ratings of the videotaped measurements of 2 raters. The resulting limits of agreement were compared with the MCID. Stratified sample, based on the intake ARA score, of 20 chronic stroke patients (median age, 62yr; median time since stroke onset, 3.6yr; mean intake ARA score, 29.2). Spearman's rank-order correlation coefficient (Spearman's rho); intraclass correlation coefficient (ICC); mean difference and limits of agreement, based on ARA sum scores; and weighted kappa, based on individual items. All intra- and interrater Spearman's rho and ICC values were higher than .98. The mean difference between ratings was highest for the interrater pair (.75; 95% confidence interval, .02-1.48), suggesting a small systematic difference between raters. Intrarater limits of agreement were -1.66 to 2.26; interrater limits of agreement were -2.35 to 3.85. Median weighted kappas exceeded .92. The high intra- and interrater reliability of the ARA test was confirmed, as was its ability to detect a clinically relevant difference of 5.7 points.

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Measurement of motor recovery after stroke. Outcome assessment and sample size requirements.

Stuart Goldstein, J R Feussner, Rebecca Duncan … (1992)

The purpose of this study was to analyze recovery of motor function in a cohort of patients presenting with an acute occlusion in the carotid distribution. Analysis of recovery patterns is important for estimating patient care needs, establishing therapeutic plans, and estimating sample sizes for clinical intervention trials. We prospectively measured the motor deficits of 104 stroke patients over a 6-month period to identify earliest measures that would predict subsequent motor recovery. Motor function was measured with the Fugl-Meyer Assessment. Fifty-four patients were randomly assigned to a training set for model development; 50 patients were assigned to a test set for model validation. In a second analysis, patients were stratified on basis of time and stroke severity. The sample size required to detect a 50% improvement in residual motor function was calculated for each level of impairment and at three points in time. At baseline the initial Fugl-Meyer motor scores accounted for only half the variance in 6-month motor function (r2 = 0.53, p less than 0.001). After 5 days, both the 5-day motor and sensory scores explained 74% of the variance (p less than 0.001). After 30 days, the 30-day motor score explained 86% of the variance (p less than 0.001). Application of these best models to the test set confirmed the results obtained with the training set. Sample-size calculations revealed that as severity and time since stroke increased, sample sizes required to detect a 50% improvement in residual motor deficits decreased. Most of the variability in motor recovery can be explained by 30 days after stroke. These findings have important implications for clinical practice and research.

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All references

Author and article information

Contributors

Johanna Jonsdottir: Role: ConceptualizationRole: Data curationRole: InvestigationRole: MethodologyRole: Project administrationRole: SupervisionRole: ValidationRole: VisualizationRole: Writing – original draftRole: Writing – review & editing

Rune Thorsen:

ORCID: http://orcid.org/0000-0003-1990-8839

Role: ConceptualizationRole: Data curationRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: Project administrationRole: SoftwareRole: SupervisionRole: ValidationRole: Writing – original draftRole: Writing – review & editing

Irene Aprile: Role: Project administrationRole: ResourcesRole: SupervisionRole: ValidationRole: Visualization

Silvia Galeri: Role: InvestigationRole: ResourcesRole: SupervisionRole: ValidationRole: Visualization

Giovanna Spannocchi: Role: InvestigationRole: ResourcesRole: SupervisionRole: ValidationRole: Visualization

Ettore Beghi: Role: ConceptualizationRole: Data curationRole: Formal analysisRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: VisualizationRole: Writing – original draft

Elisa Bianchi: Role: Data curationRole: Formal analysisRole: ValidationRole: VisualizationRole: Writing – original draft

Angelo Montesano: Role: ResourcesRole: SupervisionRole: ValidationRole: VisualizationRole: Writing – review & editing

Maurizio Ferrarin: Role: ConceptualizationRole: Data curationRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: Project administrationRole: SoftwareRole: VisualizationRole: Writing – original draftRole: Writing – review & editing

Andrea Martinuzzi: Role: Editor

Journal

Journal ID (nlm-ta): PLoS One

Journal ID (iso-abbrev): PLoS ONE

Journal ID (publisher-id): plos

Journal ID (pmc): plosone

Title: PLoS ONE

Publisher: Public Library of Science (San Francisco, CA USA )

ISSN (Electronic): 1932-6203

Publication date (Electronic): 4 December 2017

Publication date Collection: 2017

Volume: 12

Issue: 12

Electronic Location Identifier: e0188642

Affiliations

[1 ] IRCCS Don Gnocchi Foundation Onlus, Milan, Italy

[2 ] IRCCS Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy

IRCCS E. Medea, ITALY

Author notes

Competing Interests: The authors have declared that no competing interests exist.

* E-mail: rthorsen@ 123456dongnocchi.it

Author information

Rune Thorsen http://orcid.org/0000-0003-1990-8839

Article

Publisher ID: PONE-D-17-08901

DOI: 10.1371/journal.pone.0188642

PMC ID: 5714329

PubMed ID: 29200424

SO-VID: 17b75631-afe1-4cf9-ac4e-5067a0883925

License:

This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

History

Date received : 24 March 2017

Date accepted : 19 October 2017

Page count

Figures: 2, Tables: 5, Pages: 16

Funding

Funded by: Lombardy Region

Award ID: Ricerca Independente

Award Recipient : Maurizio Ferrarin

Funded by: Italian Ministry of Health

Award ID: Ricerca Corrente

This project was funded by a research grant from the Italian region Lombardia ‘Regione Lombardia, Ricerca Indipendente’ and the Italian Ministry of Health ‘Ricerca Corrente’.

Custom metadata

Data Availability All relevant data are within the paper and its Supporting Information files.