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Synergistic effect of acupuncture and mirror therapy on post-stroke upper limb dysfunction: a study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:Upper limb dysfunction is common after stroke, posing an important challenge for post-stroke rehabilitation. The clinical efficacy of acupuncture for the recovery of post-stroke upper limb function has been previously demonstrated. Mirror therapy (MT) has also been found to be effective. However, the effects of acupuncture and MT have not been systematically compared. This trial aims to elucidate the synergistic effects of acupuncture and MT on upper limb dysfunction after stroke. METHODS:A 2 × 2 factorial randomized controlled trial will be conducted at the rehabilitation hospitals affiliated with Fujian University of Traditional Chinese Medicine. A total of 136 eligible subjects will be randomly divided into acupuncture treatment (AT), MT, combined treatment, and control groups in a 1:1:1:1 ratio. All subjects will receive conventional treatment. The interventions will be performed 5 days per week for 4 weeks. AT, MT, and combined treatment will be performed for 30 min per day (combined treatment: AT 15 min + MT 15 min). The primary outcomes in this study will be the mean change in scores on both the FMA and WMFT from baseline to 4 weeks intervention and at 12 weeks follow-up between the two groups and within groups. The secondary outcomes are the mean change in the scores on the Visual Analogue Scale, Stroke Impact Scale, and modified Barthel index. Medical abstraction of adverse events will be assessed at each visit. DISCUSSION:The results of this trial will demonstrate the synergistic effect of acupuncture and MT on upper limb motor dysfunction after stroke. In addition, whether AT and MT, either combined or alone, are more effective than the conventional treatment in the management of post-stroke upper limb dysfunction will also be determined. TRIAL REGISTRATION:Chinese Clinical Trial Registry: ChiCTR-IOR-17011118 . Registered on April 11, 2017. Version number: 01.2016.09.1.

SUBMITTER: Xu Y

PROVIDER: S-EPMC5984408 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature

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Synergistic effect of acupuncture and mirror therapy on post-stroke upper limb dysfunction: a study protocol for a randomized controlled trial.

Xu Ying Y Lin Shufang S Jiang Cai C Ye Xiaoqian X Tao Jing J Wilfried Schupp S Wong Alex W K AWK Chen Lidian L Yang Shanli S

Trials 20180531 1

<h4>Background</h4>Upper limb dysfunction is common after stroke, posing an important challenge for post-stroke rehabilitation. The clinical efficacy of acupuncture for the recovery of post-stroke upper limb function has been previously demonstrated. Mirror therapy (MT) has also been found to be effective. However, the effects of acupuncture and MT have not been systematically compared. This trial aims to elucidate the synergistic effects of acupuncture and MT on upper limb dysfunction after str ...[more]

PMID: 29855360

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Project description:IntroductionThe incidence of stroke sequelae among patients is as high as 70%-80%. Flexor spasm is the most common stroke sequela, presenting a heavy burden to the patients and their families. This study will evaluate the results of randomized controlled trials to determine the efficacy and safety of hand manipulation acupuncture for the treatment of upper limb motor dysfunction after stroke.MethodsEight databases, including China National Knowledge Infrastructure, Chinese Scientific Journal Database, Cochrane Central Register of Controlled Trials, Embase, MEDLINE, PubMed, Wanfang Database, and Web of Science, will be searched using English and Chinese search strategies. In addition, manual retrieval of research papers, conference papers, ongoing experiments, and internal reports, among others, will supplement electronic retrieval. All eligible studies published on or before January 15, 2021 will be selected. To enhance the effectiveness of the study, only clinical randomized controlled trials related to the use of manual acupuncture for the treatment of upper limb motor dysfunction after stroke will be included.AnalysisThe Fugl-Meyer upper extremity assessment will be the primary outcome measure, whereas the Wolf Motor Function Test, Modified Ashworth Scale, arm movement survey test table, and upper extremity freehand muscle strength assessment scores will be the secondary outcomes. Side effects and adverse events will be included as safety evaluations. To ensure the quality of the systematic evaluation, study selection, data extraction, and quality assessment will be independently performed by two authors, and a third author will resolve any disagreement.Ethics and disseminationThis systematic review will evaluate the efficacy and safety of manual acupuncture for the treatment of upper limb motor dysfunction after stroke. Since all included data will be obtained from published articles, it does not require ethical approval and will be published in a peer-reviewed journal. INPLASY registration number: INPLASY202110071.

Project description:BackgroundStroke patients are often affected by arm paresis, have functional impairments and receive help from professional or informal caregivers. Progressive resistance training is a common intervention for functional impairments after paresis. Randomised controlled trials (RCT) showed benefits for functional recovery after resistance training. However, there is a lack of evidence for strength training in subacute stroke patients. The aim of this study is to investigate safety and effectiveness of arm strength training in subacute stroke patients.MethodsWe will conduct a prospective, assessor-blinded RCT of people with subacute stroke. We will randomly assign patients to one of two parallel groups in a 1:1 ratio and will use concealed allocation. The intervention group will receive, in addition to standard treatment, high-intensity arm training (three times per week, over three weeks; 60 min each session; with a total of nine additional sessions). The control group will receive, in addition to standard treatment, low-intensity arm training (same quantity, frequency and treatment time as the intervention group). Standard treatment for the affected arm includes mobilisation, stretching, therapeutic positioning, arm and hand motor training, strengthening exercises, mechanical assisted training, functional training and task-oriented training. The primary efficacy endpoint will be grip strength. Secondary outcome measures will be Modified Ashworth Scale, Motricity Index, Fugl-Meyer Assessment for the upper limb, Box and Block Test and Goal Attainment Scale for individual participatory goals. We will measure primary and secondary outcomes with blinded assessors at baseline and immediately after three weeks of additional therapy. Based on our sample size calculation, 78 patients will be recruited from our rehabilitation hospital in two and a half years. Drop-out rates and adverse events will be systematically recorded.DiscussionThis study attempts to close the evidence gap for effects of arm strength training in subacute stroke patients. The results of this trial will provide robust evidence for effects and safety of high-intensity arm training for people with stroke.Trial registrationGerman Clinical Trials Register, DRKS00012484 . Registered on 26 May 2017.

Project description:Background: Deficits in interjoint coordination, such as the inability to move out of synergy, are frequent symptoms in stroke subjects with upper limb impairments that hinder them from regaining normal motor function. Kinematic measurements allow a fine-grained assessment of movement pathologies, thereby complementing clinical scales, like the Fugl-Meyer Motor Assessment of the Upper Extremity (FMMA-UE). The study goal was to investigate the effects of the performed task, the tested arm, the dominant affected hand, upper limb function, and age on spatiotemporal parameters of the elbow, shoulder, and trunk. The construct validity of the metrics was examined by relating them with each other, the FMMA-UE, and its arm section. Methods: This is a cross-sectional observational study including chronic stroke patients with mild to moderate upper limb motor impairment. Kinematic measurements were taken using a wearable sensor suit while performing four movements with both upper limbs: (1) isolated shoulder flexion, (2) pointing, (3) reach-to-grasp a glass, and (4) key insertion. The kinematic parameters included the joint ranges of shoulder abduction/adduction, shoulder flexion/extension, and elbow flexion/extension; trunk displacement; shoulder-elbow correlation coefficient; median slope; and curve efficiency. The effects of the task and tested arm on the metrics were investigated using a mixed-model analysis. The validity of metrics compared to clinically measured interjoint coordination (FMMA-UE) was done by correlation analysis. Results: Twenty-six subjects were included in the analysis. The movement task and tested arm showed significant effects (p < 0.05) on all kinematic parameters. Hand dominance resulted in significant effects on shoulder flexion/extension and curve efficiency. The level of upper limb function showed influences on curve efficiency and the factor age on median slope. Relations with the FMMA-UE revealed the strongest and significant correlation for curve efficiency (r = 0.75), followed by shoulder flexion/extension (r = 0.68), elbow flexion/extension (r = 0.53), and shoulder abduction/adduction (r = 0.49). Curve efficiency additionally correlated significantly with the arm subsection, focusing on synergistic control (r = 0.59). Conclusion: The kinematic parameters of the upper limb after stroke were influenced largely by the task. These results underpin the necessity to assess different relevant functional movements close to real-world conditions rather than relying solely on clinical measures. Study Registration: clinicaltrials.gov, identifier NCT03135093 and BASEC-ID 2016-02075.

Project description:IntroductionEffective interventions to promote upper-limb recovery poststroke are characterised by intensive and repetitive movements. However, the repetitive nature of practice may adversely impact on adherence. Therefore, the development of rehabilitation devices that can be used safely and easily at home, and are motivating, enjoyable and affordable is essential to the health and well-being of stroke survivors.The Neurofenix platform is a non-immersive virtual reality device for poststroke upper-limb rehabilitation. The platform uses a hand controller (a NeuroBall) or arm bands (NeuroBands) that facilitate upper-limb exercise via games displayed on a tablet. The Rehabilitation via HOMe Based gaming exercise for the Upper-limb post Stroke trial aims to determine the safety, feasibility and acceptability of the Neurofenix platform for home-based rehabilitation of the upper-limb poststroke.Methods and analysisThirty people poststroke will be provided with a Neurofenix platform, consisting of a NeuroBall or NeuroBands (dependent on impairment level), seven specially designed games, a tablet and handbook to independently exercise their upper limb for 7 weeks. Training commences with a home visit from a research therapist to teach the participant how to safely use the device. Outcomes assessed at baseline and 8 weeks and 12 weeks are gross level of disability, pain, objectively measured arm function and impairment, self-reported arm function, passive range of movement, spasticity, fatigue, participation, quality of life (QOL) and health service use. A parallel process evaluation will assess feasibility, acceptability and safety of the intervention through assessment of fidelity to the intervention measured objectively through the Neurofenix platform, a postintervention questionnaire and semistructured interviews exploring participants' experiences of the intervention. The feasibility of conducting an economic evaluation will be determined by collecting data on QOL and resource use.Ethics and disseminationEthics approval granted from Brunel University London (10249-MHR-Mar/2018-12322-2). Trial results will be submitted for publication in journals, presented at national and international conferences and distributed to people with stroke.Trial registration numberISRCTN60291412; Pre-results.

Project description:BackgroundImproving upper limb (UL) motor recovery after stroke represents a major clinical and scientific goal. We aim to complete three systematic reviews to estimate the (1) association between time to start of UL therapy and motor recovery, (2) relative efficacy of different UL therapy approaches post-stroke and (3) cost-effectiveness of UL therapy interventions.MethodsWe have designed a systematic review protocol to address three systematic review questions that were each registered with PROSPERO. The search will be conducted in MEDLINE, EMBASE, and Cochrane Controlled Register of Trials. We will include randomised controlled trials, non-randomised clinical trials, before-after studies and observational studies of adult stroke survivors with an average stroke onset < 6 months, undergoing hospital-based therapy to improve UL function. Eligible interventions will aim to promote UL functional recovery. Two reviewers will independently screen, select and extract data. Study risk of bias will be appraised using appropriate tools. Clinical measures of motor recovery will be investigated (primary measure Fugl Meyer UL assessment), as well as measures of health-related quality of life (primary measure EQ-5D) and all cost-effectiveness analyses completed. Secondary outcomes include therapy dose (minutes, weeks, repetitions as available) and safety (i.e. adverse events, serious adverse events). A narrative synthesis will describe quality and content of the evidence. If feasible, we will conduct random effects meta-analyses where appropriate.DiscussionWe anticipate the findings of this review will increase our understanding of UL therapy and inform the generation of novel, data-driven hypotheses for future UL therapy research post-stroke.Systematic review registrationPROSPERO, http://www.crd.york.ac.uk/PROSPERO/display_record.php?ID=CRD42018019367, http://www.crd.york.ac.uk/PROSPERO/display_record.php?ID=CRD42018111629, http://www.crd.york.ac.uk/PROSPERO/display_record.php?ID=CRD42018111628.

Dataset Information

Synergistic effect of acupuncture and mirror therapy on post-stroke upper limb dysfunction: a study protocol for a randomized controlled trial.

Publications

Synergistic effect of acupuncture and mirror therapy on post-stroke upper limb dysfunction: a study protocol for a randomized controlled trial.

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