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Rationale and design of the theRapeutic effects of peroneal nerve functionAl electrical stimuLation for Lower extremitY in patients with convalescent poststroke hemiplegia (RALLY) study: study protocol for a randomised controlled study.

ABSTRACT: INTRODUCTION:Increasing evidence supports the utilisation of functional electrical stimulation (FES) to improve gait following stroke; however, few studies have focused exclusively on its use in the convalescent phase. In addition, its efficacy in patients with a non-Western life style has not been evaluated. METHODS AND ANALYSIS:This is a randomised, controlled, open-label multicentre study, comparing rehabilitation with and without FES. The purpose of our study is to test the hypothesis that the FES system improves walking ability in Japanese patients with hemiplegia during the convalescent phase. Two hundred patients aged 20-85 years who had an initial stroke ≤6 months prior to the enrolment, are in a convalescent phase (after the end of acute phase treatment, within 6 months after the onset of stroke) with functional ambulation classification 3 or 4 and have a hemiplegic gait disorder (drop foot) due to stroke have been recruited from 21 institutions in Japan. The patients are randomised in 1:1 fashion to usual gait rehabilitation or rehabilitation using FES (Walkaide). The trial duration is 8 weeks, and the primary outcome measured will be the change in maximum distance from baseline to the end of the trial, as measured with the 6 min walk test (6-MWT). The 6-MWT is performed barefoot, and the two treatment groups are compared using the analysis of covariance. ETHICS AND DISSEMINATION:This study is conducted in accordance with the principles of the Declaration of Helsinki and the Ethical Guidelines for Medical and Health Research Involving Human Subjects and is approved by the ethics committee of all participating institutions. The published results will be disseminated to all the participants by the study physicians. TRIAL REGISTRATION NUMBER:The University Hospital Medical Information Network-Clinical Studies Registry (UMIN000020604).

SUBMITTER: Matsumoto S

PROVIDER: S-EPMC6886987 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:INTRODUCTION:Acupuncture is safe and effective for improving the motor function of poststroke hemiplegic patients, but there still exists a certain gap between clinical practice and understanding its neural mechanisms. The cerebral functional reconstruction after unilateral motor pathway injury exhibits a bilateral tendency, however current studies seldom pay attention to it. Hence, based on cerebral bilateral connections, the underlying mechanism of acupuncture in stroke rehabilitation remains an area for further research. The results of this study will increase our understanding of acupuncture-induced motor recovery in patients who had suffered a stroke and demonstrate the differences in brain response and clinical assessments. METHODS AND ANALYSIS:This is a single-centre, randomised controlled, paralleled neuroimaging trial, with patients and outcome assessors blinded. Thirty patients who had a stroke with motor dysfunction meeting the inclusion criteria will be randomly assigned (2:1) to receive either 10 sessions true or sham acupoints treatments (five sessions per week for 2 weeks). All the participants will receive conventional standard medical care and rehabilitation. Motor function assessments and neuroimaging scanning will be conducted before and after the entire acupuncture treatment. The clinical and neuroimaging data will be analysed, respectively. The voxel-mirrored homotopic connectivity will be the primary outcome and the primary effect indicator. The secondary outcomes comprise clinical evaluations and neuroimaging assessments, which include Fugl-Meyer Assessment, the National Institutes of Health Stroke Scale, fractional anisotropy and gray matter volume. The Needle Sensation Assessment Scale is an additional outcome. The correlation analysis will be explored between the neuroimaging indicators, clinical motor assessments and needle sensation. ETHICS AND DISSEMINATION:The protocol has been approved by the ethics committee of Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine (DZMEC-KY-2018-04). The results of the neuroimaging trial will be disseminated through peer-reviewed publications and conferences. TRIAL REGISTRATION NUMBER:Chinese Clinical Trials Registry (ChiCTR 1800016263).

Project description:BackgroundPeripheral changes to muscle and motor nerves occur following stroke, which may further impair functional capacity. We investigated whether a year-long use of an implanted peroneal FES system reverses stroke-related changes in muscles and motor nerves in people with foot drop in the chronic phase after supratentorial stroke.MethodsThirteen persons with a chronic stroke (mean age 56.1 years, median Fugl-Meyer Assessment leg score 71%) were included and received an implanted peroneal FES system (ActiGait®). Quantitative muscle ultrasound (QMUS) images were obtained bilaterally from three leg muscles (i.e. tibialis anterior, rectus femoris, gastrocnemius). Echogenicity (muscle ultrasound gray value) and muscle thickness were assessed over a one-year follow-up and compared to age-, sex-, height- and weight-corrected reference values. Compound motor action potentials (CMAPs) and motor evoked potentials (MEPs) were obtained from the tibialis anterior muscle. Generalized estimated equation modeling was used to assess changes in QMUS, CMAPs and MEPs outcomes over the follow-up period.ResultsEchogenicity of the tibialis anterior decreased significantly during the follow-up on the paretic side. Z-scores changed from 0.88 at baseline to - 0.15 after 52 weeks. This was accompanied by a significant increase in muscle thickness on the paretic side, where z-scores changed from - 0.32 at baseline to 0.48 after 52 weeks. Echogenicity of the rectus femoris normalized on both the paretic and non-paretic side (z-scores changed from - 1.09 and - 1.51 to 0.14 and - 0.49, respectively). Amplitudes of CMAP and MEP (normalized to CMAP) were reduced during follow-up, particularly on the paretic side (ΔCMAP = 20% and ΔMEP = 14%).ConclusionsWe show that the structural changes to muscles following stroke are reversible with FES and that these changes might not be limited to electrically stimulated muscles. No evidence for improvement of the motor nerves was found.

Dataset Information

Rationale and design of the theRapeutic effects of peroneal nerve functionAl electrical stimuLation for Lower extremitY in patients with convalescent poststroke hemiplegia (RALLY) study: study protocol for a randomised controlled study.

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