Effect of mobile-based self-management application on stroke outcomes: a study protocol for triple blinded randomized controlled trial.

BACKGROUND: Stroke is the main leading cause of long-term disabilities in the world. This protocol will be implemented for a study to evaluate the effects of an Android-based self-care application on patients with stroke. METHODS: The first stage will include the development of an android-based application using JAVA programming language for developing the user interface and ASP.NET Core for developing Web server. The second stage will be conducted using triple blinded randomized clinical trial (RCT). The sample size will include 60 patients with recent stroke and partial paralysis of limbs, who will be divided into two groups of intervention and control through permuted block randomization method. Patients in both groups will receive usual medical care, but those in the intervention group will also use an Android-based application for a period of two months. Outcomes will be assessed using valid and reliable questionnaires. DISCUSSION: The assessed outcomes will include stroke severity using National Institute of Health Stroke Scale (NIHSS) score, ability to perform activities of daily living using Barthel Index (BI) score, depression rate using Beck Depression Inventory (BDI-II) score, quality of life using EQ-5D-3L score, medication adherence using Modified Morisky Medication Adherence Scale (MMAS-8) score, patient satisfaction using Patient Satisfaction Questionnaire (PSQ) score and the number and type of complications in patients in two groups. These outcomes will be assessed at baseline, after two months and after three months from the beginning of the intervention. Intervention effects on the measured variables will also be evaluated using appropriate statistical tests based on the type of variable distribution. Potential consequences of the study might be the improvement of the measured variables in the intervention group compared to that of the control group. The expected results are that the intervention may significantly improve the status of the measured variables in the intervention group compared to that of the control group. If the outcomes of the intervention group do not change significantly compared to those of the control group, it can be due to different reasons. However, this can most likely be attributed to incorrect or insufficient use of the application by patients. TRIAL REGISTRATION: This protocol is registered in the Iranian registration of clinical trial (IRCT) on November 7, 2020 with the code IRCT20201015049037N1. URL: https://irct.ir/trial/51674.

High-dose ω-3 Fatty Acid Plus Vitamin D3 Supplementation Affects Clinical Symptoms and Metabolic Status of Patients with Multiple Sclerosis: A Randomized Controlled Clinical Trial.

Background: Combined omega-3 fatty acid and vitamin D supplementation may improve multiple sclerosis (MS) by correcting metabolic abnormalities and attenuating oxidative stress and inflammation. Objective: This study aimed to determine the effects of ω-3 fatty acid and vitamin D cosupplementation on the disability score and metabolic status of patients with MS. Methods: This was a randomized, placebo-controlled clinical trial with Expanded Disability Status Scale (EDSS) score and inflammation as primary outcomes and oxidative stress biomarkers and metabolic profile as secondary outcomes. Patients, aged 18-55 y, were matched for disease EDSS scores, gender, medications, BMI, and age (n = 53) and randomly received a combined 2 × 1000 mg/d ω-3 fatty acid and 50,000 IU/biweekly cholecalciferol supplement or placebo for 12 wk. The placebos were matched in colour, shape, size, packaging, smell, and taste with supplements. Fasting blood samples were collected at baseline and end of intervention to measure different outcomes. Multiple linear regression models were used to assess treatment effects on outcomes adjusting for confounding variables. Results: Patients taking ω-3 fatty acid plus vitamin D supplements showed a significant improvement in EDSS (ß -0.18; 95% CI: -0.33, -0.04; P = 0.01), compared with placebo. Serum high-sensitivity C-reactive protein (ß -1.70 mg/L; 95% CI: -2.49, -0.90 mg/L; P < 0.001), plasma total antioxidant capacity (ß +55.4 mmol/L; 95% CI: 9.2, 101.6 mmol/L; P = 0.02), total glutathione (ß +51.14 µmol/L; 95% CI: 14.42, 87.87 µmol/L; P = 0.007), and malondialdehyde concentrations (ß -0.86 µmol/L; 95% CI: -1.10, -0.63 µmol/L; P < 0.001) were significantly improved in the supplemented group compared with the placebo group. In addition, ω-3 fatty acid and vitamin D cosupplementation resulted in a significant reduction in serum insulin, insulin resistance, and total/HDL-cholesterol, and a significant increase in insulin sensitivity and serum HDL-cholesterol concentrations. Conclusion: Overall, taking ω-3 fatty acid and vitamin D supplements for 12 wk by patients with MS had beneficial effects on EDSS and metabolic status. This trial was registered at the Iranian website (www.irct.ir) for registration of clinical trials as IRCT2017090133941N20.

Functional requirements of a mobile-based application for stroke self-management: A Delphi study.

This study aimed to determine the functional requirements of a self-management mobile application for stroke survivors. For extracting the initial functional requirements, a literature review as well as interviews with 17 patients and caregivers were done. The results were analyzed using the content analysis method. The initial extracted requirements were then provided to the specialists by the Delphi technique to determine the final functional requirements. Content validity ratio (CVR) and content validity index (CVI) were calculated according to the Lawshe model. Criteria for item approval included CVR > 0.49 and CVI > 0.79. Finally, the approved items were turned into a five-point Likert scale questionnaire and were then provided to 53 experts and items with a mean score higher than 3.75 were approved. Functional requirements including creating a user account, educational material, support services, providing reminders and alerts for drugs administration and physician appointments, and rehabilitation exercises (to improve balance, upper and lower extremities rehabilitation, and activities of daily living (ADLs)) were approved. Most of the approved functional requirements were related to rehabilitation exercises for improving upper limb motor function. The experts did not approve the requirements for using splints and slings or the recommendation to take some medications.

Inhibitory effects of chronic administration of vitamin D3 on pentylenetetrazole-induced seizures in mice.

Vitamin D3 as a neuroactive steroid hormone plays an important role in the nervous system. Recent clinical and experimental studies have shown an association between vitamin D-related disorders and epilepsy. Therefore, this study was designed to examine the effects of chronic administration of vitamin D3 on pentylenetetrazole (PTZ)-induced seizure in mice. This interventional study was conducted on 120 mice in 12 groups. Two control groups acutely and chronically received a mixture of almond oil and paraffin; three groups were acutely given vitamin D3 at doses of 2000, 4000 and 6000 IU/kg; three groups chronically received vitamin D3 with similar doses for two weeks and two groups chronically and acutely received a sub-effective dose of vitamin D3 and diazepam. Slow intravenous infusion of PTZ (5 mg/mL) was performed at a constant rate (0.3 mL/min) via an infusion pump to induce clonic and tonic seizures. Acute injection of different concentrations of vitamin D3 (2000, 4000 and 6000 IU/kg i.p.) did not significantly increase a seizure threshold. However, a seizure threshold in the groups chronically treated with 4000, and 6000 IU/kg of vitamin D3 was significantly higher than that in the control group (P < 0.001). Moreover, a combination of the sub-effective dose of vitamin D3 (2000 IU/kg) and diazepam (0.1 mg/kg) significantly increased seizure threshold. Our findings suggest that administration of vitamin D supplement can be considered as a potential add-on treatment in seizure and due to the vitamin D deficiency results from the long-term use of most anti-seizure drugs, this supplementation becomes more important.

Intelligent Computer Systems for Multiple Sclerosis Diagnosis: a Systematic Review of Reasoning Techniques and Methods.

OBJECTIVE: Intelligent computer systems are used in diagnosing Multiple Sclerosis and help physicians in the accurate and timely diagnosis of the disease. This study focuses on a review of different reasoning techniques and methods used in intelligent systems to diagnose MS and analyze the application and efficiency of different reasoning methods in order to find the most efficient and applicable methods and techniques for MS diagnosis. METHODS: A complete research was carried out on articles in various electronic databases based on Mesh vocabulary. 85 articles out of 614 articles published in English between 2000 to 2018 were analyzed, 30 of which have been selected based on inclusion criteria such as system scope and domain, full description of reasoning method and system evaluation. RESULTS: Results indicate that different reasoning methods are used unintelligent systems of MS diagnosis. In 27% of the studies, the rule-based method was used, in 20% the fuzzy logic method, in 18%the artificial neural network method, and in 35% other reasoning methods were used. The average sensitivity, specificity and accuracy of reasoning methods were0.91, 0.77, and 0.86, respectively. CONCLUSIONS: Rule-based, fuzzy-logic and artificial neural network methods have had more applications in intelligent systems for the diagnosis of MS, respectively. The highest rate of sensitivity and accuracy indexes is associated to the neural network reasoning method at 0.97 and 0.99, respectively .In the fuzzy logic method, the Kappa rate has been reported as one, which shows full conformity between software diagnosis and the physician's decision .In some articles, in order to remove the limitations of the methods and enhance their efficiency, combinations of different methods are used.

Study of the correlation of serum selenium level with Behcet's disease.

BACKGROUND: Selenium, like other trace elements and antioxidant enzymes, is known as an antioxidant and immunomodulator trace element. Due to recent evidence for selenium deficiency in Behcet's syndrome, this study is to evaluate the correlation of serum selenium level with Behcet's disease (BD). MATERIALS: This case-control study was conducted on 46 BD patients and 46 healthy controls in a rheumatology research centre. The case and control groups were both age- and race-matched. Serum selenium level was then measured by atomic absorption spectrometry Shimadzu AA-680. Average serum levels of both groups were then compared and analyzed using t-test. RESULTS: Mean serum selenium levels of patients appeared to be 66.4 ± 15.38 µg/L which was significantly lower than that in the healthy controls (86.87 ± 17.18 µg/L) (P < 0.005). Taking physician global assessment of disease activity into account, significant difference was detected between the patients with active disease (66.57 ± 15.21 µg/L) and those in the inactive state (65.83 ± .75 µg/L). Regardless of the findings mentioned above, serum selenium level was meaningfully elevated among the patients with ocular involvement (P < 0.001). CONCLUSIONS: These findings demonstrated that selenium serum level among BD patients was lower than that in healthy controls, whereas among the patients with ocular involvement it was higher than those not involved.