Abstract P206: Wearable Myoelectric Interface Training for Improving Arm Movement in Chronic Stroke

Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
Na-Teng Hung ◽  
Vivek Paul ◽  
Torin Kovach ◽  
Marc W Slutzky
Keyword(s):  
Computer Games ◽  
High Intensity ◽  
Arm Movement ◽  
Chronic Stroke ◽  
Control Group ◽  
High Dose ◽  
Stroke Survivors ◽  
Sham Control ◽  
Co Activation ◽  
Sham Control Group

Impaired arm movement after stroke is due not only to weakness and spasticity, but also to abnormal co-activation (a.k.a. abnormal synergies). Yet, few stroke therapies are aimed to reduce this co-activation. We designed a myoelectric computer interface (MyoCI) that provides feedback to stroke survivors to reduce this abnormal co-activation and associated arm impairment. Here, we describe a novel, wearable version of the MyoCI to control custom-designed computer games as a home-based therapy for chronic stroke survivors. This therapy, called the myoelectric interface for neurorehabilitation training (MINT), enables high-intensity, high-dose training using an inexpensive device at home. The MINT device records surface EMGs from 2-3 arm muscles and wirelessly controls games on a laptop or tablet. By mapping the muscle activities to orthogonal directions of cursor movements, the games operantly condition the participants to learn to reduce abnormal co-activation between the muscles. We are currently investigating this device in severely impaired stroke survivors (Fugl-Meyer score <30). Participants were asked to train 90 min per day, 6 days a week, for a total of 6 weeks, with different variants of the paradigm (2 or 3 muscles at a time) vs. a sham control group that trained on one muscle. We surveyed participants about their engagement with the game using a modified Intrinsic Motivation Inventory (IMI). Eighteen participants have completed the 6-week training to date. They averaged 75±19 min of daily training out of the 90 that were asked. Overall, 60% of participants surveyed enjoyed, and 90% were positively motivated by, the training. A few participants had significant difficulty with the laptops due to inexperience with computers. Participants’ performance on the game, measured by weighted time-to-target, improved steadily overall in the experimental group, while the sham control group stayed at high performance throughout. The MINT provides a motivating, enjoyable way to provide high-intensity therapy in the home to stroke survivors. This therapy is a new mechanism of action for stroke rehabilitation and we are evaluating its efficacy in an ongoing randomized controlled trial.

scholarly journals Myoelectric Computer Interface Training for Reducing Co-Activation and Enhancing Arm Movement in Chronic Stroke Survivors: A Randomized Trial

2019 ◽  
Vol 33 (4) ◽  
pp. 284-295 ◽  
Author(s):  
Emily M. Mugler ◽  
Goran Tomic ◽  
Aparna Singh ◽  
Saad Hameed ◽  
Eric W. Lindberg ◽  
...  
Keyword(s):  
Range Of Motion ◽  
Muscle Activation ◽  
Arm Movement ◽  
Chronic Stroke ◽  
Computer Interface ◽  
Stroke Survivors ◽  
Training Methods ◽  
Training Dose ◽  
Muscle Activation Patterns ◽  
Co Activation

Background. Abnormal muscle co-activation contributes to impairment after stroke. We developed a myoelectric computer interface (MyoCI) training paradigm to reduce abnormal co-activation. MyoCI provides intuitive feedback about muscle activation patterns, enabling decoupling of these muscles. Objective. To investigate tolerability and effects of MyoCI training of 3 muscle pairs on arm motor recovery after stroke, including effects of training dose and isometric versus movement-based training. Methods. We randomized chronic stroke survivors with moderate-to-severe arm impairment to 3 groups. Two groups tested different doses of isometric MyoCI (60 vs 90 minutes), and one group tested MyoCI without arm restraint (90 minutes), over 6 weeks. Primary outcome was arm impairment (Fugl-Meyer Assessment). Secondary outcomes included function, spasticity, and elbow range-of-motion at weeks 6 and 10. Results. Over all 32 subjects, MyoCI training of 3 muscle pairs significantly reduced impairment (Fugl-Meyer Assessment) by 3.3 ± 0.6 and 3.1 ± 0.7 ( P < 10−4) at weeks 6 and 10, respectively. Each group improved significantly from baseline; no significant differences were seen between groups. Participants’ lab-based and home-based function also improved at weeks 6 and 10 ( P ≤ .01). Spasticity also decreased over all subjects, and elbow range-of-motion improved. Both moderately and severely impaired patients showed significant improvement. No participants had training-related adverse events. MyoCI reduced abnormal co-activation, which appeared to transfer to reaching in the movement group. Conclusions. MyoCI is a well-tolerated, novel rehabilitation tool that enables stroke survivors to reduce abnormal co-activation. It may reduce impairment and spasticity and improve arm function, even in severely impaired patients.

scholarly journals Five Different Noise Intensities Robustly Affects Corticosterone, Gastrin and Endothelin-1 Responses and Initiated Gastric Tissue Damage in Wistar Rats

2021 ◽  
pp. 54-69
Author(s):  
Ravinder Kumar Mehra ◽  
Mahesh Prashad ◽  
Dinesh Kumar Sharma ◽  
Prevesh Kumar
Keyword(s):  
Stress Response ◽  
Tissue Damage ◽  
Biological Systems ◽  
Gastric Damage ◽  
Control Group ◽  
Stress Exposure ◽  
Sham Control ◽  
Endothelin 1 ◽  
Noise Stress ◽  
Sham Control Group

Likewise other stress response noise stress is also affects the homeostasis of the biological systems and produce stress response in the form of Corticosterone to prevent the damage but if the exposure is longer with higher magnitude it may disrupt the robust ability of the homeostasis and could produce the damage to the biological systems. The goal of our study was to see how five different noise intensities affected stomach tissue damage. 42 healthy rats were divided into five different stress exposure group, normal control (NC) and sham control (SC) groups. Noise stress exposure was delivered for 1 hour per day continued for 30 days in all five noise exposed groups by specially designed noise chamber whereas sham control group of animals kept in noise chamber for 1 hour per day continued for 30 days without noise stress exposure and control group of animals neither exposed to noise stress of any intensities and nor kept in noise chamber without noise but remain in the same experimental room in their homecage for 30 days respectively. Results of the study showed that animals exposed to 60 and 80 dB noise give habituated and not significant Corticosterone, Gastrin and Endothelin-1 responses compared to NC and SC groups while animals exposed to 100, 120 and 140 dB had significantly higher Corticosterone, Gastrin and Endothelin-1 response and also chronic gastric damage was observed compared to later two noise exposed groups respectively. Study concluded that not only higher but also lower noise intensities also initiated the gastric damage even after the adaptation.

scholarly journals Development and Clinical Evaluation of a Web-Based Upper Limb Home Rehabilitation System Using a Smartwatch and Machine Learning Model for Chronic Stroke Survivors: Prospective Comparative Study (Preprint)

2019 ◽  
Author(s):  
Sang Hoon Chae ◽  
Yushin Kim ◽  
Kyoung-Soub Lee ◽  
Hyung-Soon Park
Keyword(s):  
Machine Learning ◽  
Home Care ◽  
Comparative Study ◽  
Internal Rotation ◽  
Chronic Stroke ◽  
Control Group ◽  
Stroke Survivors ◽  
Home Based ◽  
Rehabilitation System ◽  
Prospective Comparative Study

BACKGROUND Recent advancements in wearable sensor technology have shown the feasibility of remote physical therapy at home. In particular, the current COVID-19 pandemic has revealed the need and opportunity of internet-based wearable technology in future health care systems. Previous research has shown the feasibility of human activity recognition technologies for monitoring rehabilitation activities in home environments; however, few comprehensive studies ranging from development to clinical evaluation exist. OBJECTIVE This study aimed to (1) develop a home-based rehabilitation (HBR) system that can recognize and record the type and frequency of rehabilitation exercises conducted by the user using a smartwatch and smartphone app equipped with a machine learning (ML) algorithm and (2) evaluate the efficacy of the home-based rehabilitation system through a prospective comparative study with chronic stroke survivors. METHODS The HBR system involves an off-the-shelf smartwatch, a smartphone, and custom-developed apps. A convolutional neural network was used to train the ML algorithm for detecting home exercises. To determine the most accurate way for detecting the type of home exercise, we compared accuracy results with the data sets of personal or total data and accelerometer, gyroscope, or accelerometer combined with gyroscope data. From March 2018 to February 2019, we conducted a clinical study with two groups of stroke survivors. In total, 17 and 6 participants were enrolled for statistical analysis in the HBR group and control group, respectively. To measure clinical outcomes, we performed the Wolf Motor Function Test (WMFT), Fugl-Meyer Assessment of Upper Extremity, grip power test, Beck Depression Inventory, and range of motion (ROM) assessment of the shoulder joint at 0, 6, and 12 months, and at a follow-up assessment 6 weeks after retrieving the HBR system. RESULTS The ML model created with personal data involving accelerometer combined with gyroscope data (5590/5601, 99.80%) was the most accurate compared with accelerometer (5496/5601, 98.13%) or gyroscope data (5381/5601, 96.07%). In the comparative study, the drop-out rates in the control and HBR groups were 40% (4/10) and 22% (5/22) at 12 weeks and 100% (10/10) and 45% (10/22) at 18 weeks, respectively. The HBR group (n=17) showed a significant improvement in the mean WMFT score (<i>P</i>=.02) and ROM of flexion (<i>P</i>=.004) and internal rotation (<i>P</i>=.001). The control group (n=6) showed a significant change only in shoulder internal rotation (<i>P</i>=.03). CONCLUSIONS This study found that a home care system using a commercial smartwatch and ML model can facilitate participation in home training and improve the functional score of the WMFT and shoulder ROM of flexion and internal rotation in the treatment of patients with chronic stroke. This strategy can possibly be a cost-effective tool for the home care treatment of stroke survivors in the future. CLINICALTRIAL Clinical Research Information Service KCT0004818; https://tinyurl.com/y92w978t

P4583Effect of permanent right internal mammary artery occlusion on right coronary artery collateral function. a randomized controlled trial

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
M R Bigler ◽  
M Stoller ◽  
C Tschannen ◽  
R Grossenbacher ◽  
C Seiler
Keyword(s):  
Coronary Artery ◽  
Angina Pectoris ◽  
Right Coronary Artery ◽  
Study Endpoint ◽  
Control Group ◽  
Sham Control ◽  
Randomized Controlled ◽  
Internal Mammary ◽  
Sham Control Group

Abstract Background Extracardiac coronary artery supply via the pericardiophrenic branch of the internal mammary arteries (IMA) has been well documented anatomically. Recently, a proof-of-concept study has found functional relevance of these anastomoses in patients with coronary artery disease (CAD) during a brief right coronary artery (RCA) occlusion. Purpose The aim of the present randomized controlled, single-blind trial was to investigate the effect of permanent right IMA (RIMA) occlusion on RCA collateral flow index (CFI) and on the occurrence of angina pectoris. We hypothesized that the change in RCA CFI from baseline to follow-up examination is higher in the group of patients with than without permanent RIMA occlusion. Methods One hundred patients with CAD were randomly allocated (1:1) to permanent RIMA device occlusion at baseline or to no RIMA occlusion (sham control group). The primary study endpoint was CFI change in the RCA from baseline to the 6-week follow-up examination. CFI is the ratio between mean coronary occlusive and aortic pressure both subtracted by central venous pressure as obtained during a 1-minute proximal RCA balloon occlusion. RCA CFI was measured at baseline before RIMA occlusion or the sham procedure and at the follow-up invasive exam. At the end of the same occlusion, occurrence of angina pectoris was assessed. Percutaneous coronary intervention (PCI) of the RCA was deferred until after follow-up RCA CFI measurement. Results There were 51 patients in the RIMA occlusion (verum) group and 49 patients in the sham control group. PCI in the left coronary territory was performed at baseline for clinical reasons in 27 patients of the verum group and in 25 patients of the sham control group. There were no differences in clinical characteristics at baseline between the groups (age 68±12 years, 88 men). RCA CFI change during the 6 weeks of follow-up was equal to +0.028±0.077 in the verum group and −0.026±0.079 in the sham control group (p=0.0017). Angina pectoris during CFI measurement had disappeared at follow-up exam in 30% of the verum group and in 2% of the sham control group (p=0.0013). Conclusions Right coronary collateral function is augmented 6 weeks after permanent RIMA occlusion when compared to sham treatment. This manifests as less frequent angina pectoris during myocardial ischemia among patients with RIMA occlusion. Acknowledgement/Funding This study was supported by a grant from the Swiss National Science Foundation for Research (grant #32003B_163256/1 to CS).

Increased Pinch Strength in Acute and Subacute Stroke Patients After Simultaneous Median and Ulnar Sensory Stimulation

2008 ◽  
Vol 23 (4) ◽  
pp. 351-356 ◽  
Author(s):  
Akkarapol Klaiput ◽  
Wasuwat Kitisomprayoonkul
Keyword(s):  
Sensory Stimulation ◽  
Pinch Strength ◽  
Control Group ◽  
Stroke Patients ◽  
Control Groups ◽  
Sham Control ◽  
Subacute Stroke ◽  
Sham Control Group ◽  
Peripheral Sensory ◽  
Stimulation Group

Background. Peripheral nerve stimulation may induce cortical adaptations as it improves pinch strength in chronic stroke patients immediately after stimulation. Objective. Test the effects of peripheral sensory stimulation on pinch strength in patients with acute and subacute stroke. Methods. Stroke patients (N = 20) who had onset less than 6 months previously and could voluntarily pinch the thumb to the index finger participated in a randomized, single-blinded, controlled study. Ten patients received 2 hours of simultaneous electrical stimulation over the median and ulnar nerves at the wrist to the level of appreciating paresthesias (peripheral sensory stimulation group). Ten control patients received stimulation to the level of perception (sham-control group). Pinch strength of the thumb pad to tip and to lateral side of the index finger of the paretic hand and the Action Research Arm test were tested before and immediately after the stimulation. Results. Lateral and tip pinch strength were significantly increased in both groups ( P < .05). Mean ± SD of increased lateral pinch strength of peripheral sensory stimulation and sham-control groups were 1.24 ± 0.54 pounds and 0.20 ± 0.28 pounds, respectively. Mean ± SD of increased tip pinch strength of peripheral sensory stimulation and sham-control groups were 1.00 ± 0.72 pounds and 0.37 ± 0.36 pounds, respectively. Increase pinch strength of the peripheral sensory stimulation group was greater than the sham-control group, with significant difference ( P < .05). The Action Research Arm test was not significantly changed after stimulation in both groups ( P > .05). Conclusion. Peripheral sensory stimulation of the paretic hand may increase pinch strength of acute and subacute stroke patients immediately after stimulation.

LOX-1 inhibition in myocardial ischemia-reperfusion injury: modulation of MMP-1 and inflammation

2002 ◽  
Vol 283 (5) ◽  
pp. H1795-H1801 ◽  
Author(s):  
Dayuan Li ◽  
Victor Williams ◽  
Ling Liu ◽  
Hongjiang Chen ◽  
Tatsuya Sawamura ◽  
...  
Keyword(s):  
Myocardial Ischemia ◽  
P38 Mapk ◽  
Adhesion Molecule ◽  
Ischemia Reperfusion ◽  
Control Group ◽  
Adhesion Molecule Expression ◽  
Sham Control ◽  
Mapk Activation ◽  
Sham Control Group ◽  
Myocardial Ischemia Reperfusion

A recently identified lectin-like oxidized low-density lipoprotein receptor (LOX-1) mediates endothelial cell injury and facilitates inflammatory cell adhesion. We studied the role of LOX-1 in myocardial ischemia-reperfusion (I/R) injury. Anesthetized Sprague-Dawley rats were subjected to 60 min of left coronary artery (LCA) ligation, followed by 60 min of reperfusion. Rats were treated with saline, LOX-1 blocking antibody JXT21 (10 mg/kg), or nonspecific anti-goat IgG (10 mg/kg) before I/R. Ten other rats underwent surgery without LCA ligation and served as a sham control group. LOX-1 expression was markedly increased during I/R ( P < 0.01 vs. sham control group). Simultaneously, the expression of matrix metalloproteinase-1 (MMP-1) and adhesion molecules (P-selectin, VCAM-1, and ICAM-1) was also increased in the I/R area ( P < 0.01 vs. sham control group). There was intense leukocyte accumulation in the I/R area in the saline-treated group. Treatment of rats with the LOX-1 antibody prevented I/R-induced upregulation of LOX-1 and reduced MMP-1 and adhesion molecule expression as well as leukocyte recruitment. LOX-1 antibody, but not nonspecific IgG, also reduced myocardial infarct size ( P < 0.01 vs. saline-treated I/R group). To explore the link between LOX-1 and adhesion molecule expression, we measured expression of oxidative stress-sensitive p38 mitogen-activated protein kinase (p38 MAPK). The activity of p38 MAPK was increased during I/R ( P < 0.01 vs. sham control), and use of LOX-1 antibody inhibited p38 MAPK activation ( P < 0.01). These findings indicate that myocardial I/R upregulates LOX-1 expression, which through p38 MAPK activation increases the expression of MMP-1 and adhesion molecules. Inhibition of LOX-1 exerts an important protective effect against myocardial I/R injury.

scholarly journals Sustained Tau Phosphorylation and Microglial Activation Following Repetitive Traumatic Brain Injury

2020 ◽  
Vol 8 (A) ◽  
pp. 837-840
Author(s):  
Andre Marolop Pangihutan Siahaan ◽  
Rr Suzy Indharty ◽  
Jessy Chrestella ◽  
Wismaji Sadewo ◽  
Steven Tandean ◽  
...  
Keyword(s):  
Traumatic Brain Injury ◽  
Brain Injury ◽  
Treatment Group ◽  
Microglial Activation ◽  
Control Group ◽  
Sprague Dawley ◽  
Sham Control ◽  
Treatment Groups ◽  
Sham Control Group ◽  
Cd 68

BACKGROUND: Repetitive traumatic brain injury (TBI), even without acute sequela, can induce a delayed neurodegenerative with overexpression of phosphorylated tau (p-tau) as hallmark, caused by chronic inflammation mediated in part by microglial activation. AIM: The aim of this study was to examine the dynamics of p-tau accumulation and microglial activation following repetitive TBI. MATERIALS AND METHODS: Thirty Sprague–Dawley rats were randomized into a sham control group and two treatment groups receiving three successive closed-skull impacts (TBI model) from a 40-g mass dropped from a 1-m height on alternating days (days 0, 1, 3, and 7). The first treatment group was sacrificed on the last day of trauma and the second treatment group after 7 days of no trauma. The expression level of p-tau was evaluated by AT-8 antibody immunostaining and microglial activation by anti-CD-68 immunostaining. RESULTS: Immunoexpression of AT-8 was significantly elevated 7 days after TBI compared to the last day of trauma and compared to the sham control group, while CD-68 expression was significantly higher than sham controls on the last day of trauma and remained elevated for 7 days without trauma. CONCLUSION: The study showed that brain trauma can induce p-tau overexpression and microglial activation that is sustained during the non-trauma period.

scholarly journals Development and Clinical Evaluation of a Web-Based Upper Limb Home Rehabilitation System Using a Smartwatch and Machine Learning Model for Chronic Stroke Survivors: Prospective Comparative Study

10.2196/17216 ◽  
2020 ◽  
Vol 8 (7) ◽  
pp. e17216
Author(s):  
Sang Hoon Chae ◽  
Yushin Kim ◽  
Kyoung-Soub Lee ◽  
Hyung-Soon Park
Keyword(s):  
Machine Learning ◽  
Home Care ◽  
Comparative Study ◽  
Internal Rotation ◽  
Chronic Stroke ◽  
Control Group ◽  
Stroke Survivors ◽  
Home Based ◽  
Rehabilitation System ◽  
Prospective Comparative Study

Background Recent advancements in wearable sensor technology have shown the feasibility of remote physical therapy at home. In particular, the current COVID-19 pandemic has revealed the need and opportunity of internet-based wearable technology in future health care systems. Previous research has shown the feasibility of human activity recognition technologies for monitoring rehabilitation activities in home environments; however, few comprehensive studies ranging from development to clinical evaluation exist. Objective This study aimed to (1) develop a home-based rehabilitation (HBR) system that can recognize and record the type and frequency of rehabilitation exercises conducted by the user using a smartwatch and smartphone app equipped with a machine learning (ML) algorithm and (2) evaluate the efficacy of the home-based rehabilitation system through a prospective comparative study with chronic stroke survivors. Methods The HBR system involves an off-the-shelf smartwatch, a smartphone, and custom-developed apps. A convolutional neural network was used to train the ML algorithm for detecting home exercises. To determine the most accurate way for detecting the type of home exercise, we compared accuracy results with the data sets of personal or total data and accelerometer, gyroscope, or accelerometer combined with gyroscope data. From March 2018 to February 2019, we conducted a clinical study with two groups of stroke survivors. In total, 17 and 6 participants were enrolled for statistical analysis in the HBR group and control group, respectively. To measure clinical outcomes, we performed the Wolf Motor Function Test (WMFT), Fugl-Meyer Assessment of Upper Extremity, grip power test, Beck Depression Inventory, and range of motion (ROM) assessment of the shoulder joint at 0, 6, and 12 months, and at a follow-up assessment 6 weeks after retrieving the HBR system. Results The ML model created with personal data involving accelerometer combined with gyroscope data (5590/5601, 99.80%) was the most accurate compared with accelerometer (5496/5601, 98.13%) or gyroscope data (5381/5601, 96.07%). In the comparative study, the drop-out rates in the control and HBR groups were 40% (4/10) and 22% (5/22) at 12 weeks and 100% (10/10) and 45% (10/22) at 18 weeks, respectively. The HBR group (n=17) showed a significant improvement in the mean WMFT score (P=.02) and ROM of flexion (P=.004) and internal rotation (P=.001). The control group (n=6) showed a significant change only in shoulder internal rotation (P=.03). Conclusions This study found that a home care system using a commercial smartwatch and ML model can facilitate participation in home training and improve the functional score of the WMFT and shoulder ROM of flexion and internal rotation in the treatment of patients with chronic stroke. This strategy can possibly be a cost-effective tool for the home care treatment of stroke survivors in the future. Trial Registration Clinical Research Information Service KCT0004818; https://tinyurl.com/y92w978t

scholarly journals Protection against Amoebic Liver Abscess in Hamster by Intramuscular Immunization with anAutographa californicaBaculovirus Driving the Expression of the Gal-Lectin LC3 Fragment

2015 ◽  
Vol 2015 ◽  
pp. 1-10 ◽  
Author(s):  
Dulce María Meneses-Ruiz ◽  
Hugo Aguilar-Diaz ◽  
Raúl José Bobes ◽  
Alicia Sampieri ◽  
Luis Vaca ◽  
...  
Keyword(s):  
Protective Antigen ◽  
Oral Immunization ◽  
Autographa Californica ◽  
Amoebic Liver Abscess ◽  
Control Group ◽  
Sham Control ◽  
Th2 Cytokine ◽  
Sham Control Group ◽  
Baculovirus System ◽  
Humoral Responses

In a previous study, we demonstrated that oral immunization usingAutographa californicabaculovirus driving the expression of the Gal-lectin LC3 fragment (AcNPV-LC3) ofEntamoeba histolyticaconferred protection against ALA development in hamsters. In this study, we determined the ability of AcNPV-LC3 to protect against ALA by the intramuscular route as well as the liver immune response associated with protection. Results showed that 55% of hamsters IM immunized with AcNPV-LC3 showed sterile protection against ALA, whereas other 20% showed reduction in the size and extent of abscesses, resulting in some protection in 75% of animals compared to the sham control group. Levels of protection showed a linear correlation with the development and intensity of specific antiamoeba cellular and humoral responses, evaluated in serum and spleen of hamsters, respectively. Evaluation of the Th1/Th2 cytokine patterns expressed in the liver of hamsters showed that sterile protection was associated with the production of high levels of IFNγand IL-4. These results suggest that the baculovirus system is equally efficient by the intramuscular as well as the oral routes for ALA protection and that the Gal-lectin LC3 fragment is a highly protective antigen against hepatic amoebiasis through the local induction of IFNγand IL-4.

scholarly journals Electro-acupuncture for central obesity: randomized, patient-assessor blinded, sham-controlled clinical trial protocol

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Linda L. D. Zhong ◽  
Xingyao Wu ◽  
Tsz Fung Lam ◽  
Ying Ping Wong ◽  
Peihua Cao ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Central Obesity ◽  
Medical Condition ◽  
The Body ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Hip Circumference ◽  
Sham Control ◽  
Sham Control Group

Abstract Background Obesity is a common medical condition. Among all the classifications of obesity, central obesity is considered to be a significant threat on the health of individuals. Scientific researches have demonstrated that the accumulation of intra-abdominal fat is associated with higher metabolic and cardiovascular disease risks independently from Body Mass Index (BMI). Our previous research found that the combination of electro-acupuncture and auricular acupressure could significantly reduce the body weight and the BMI compared to sham control group. Methods/design This is a patient-assessor blinded, randomized, sham-controlled clinical trial on electro-acupuncture for central obesity. One hundred sixty-eight participants with central obesity will be randomly assigned to two groups, which are the acupuncture group and the sham control group. The whole study duration will be 8-week treatment plus 8-week follow up. The primary outcome is the change in waist circumference before and after the treatment. The secondary outcomes include the changes in hip circumference, waist-to-hip circumference ratio, BMI and body fat percentage during the treatment and follow-up. Conclusion The trial will evaluate the efficacy and safety of electro-acupuncture for central obesity compared with sham acupuncture. The study may provide the solid evidence of electro-acupuncture on central obesity in Hong Kong. Trial registration ClinicalTrials.gov Identifier: NCT03815253,Registered 24 Jan 2019.

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