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NCT ID: NCT02390206 Completed - Spasticity Clinical Trials

Study on the Use of Botulinum Toxin Type A in the Treatment of Chronic Post-stroke Spastic Patients

B-CAUSE
Start date: June 2015
Phase: N/A
Study type: Observational

The purpose of this study is to document the effectiveness of treating chronic post-stroke spastic patients with Botulinum Toxin type A.

NCT ID: NCT02390115 Completed - Stroke Clinical Trials

Effects of Elastic Tape in Shoulder Movements in Hemiparetic Subjects

Start date: March 2015
Phase: N/A
Study type: Interventional

The stroke is the second cause of death and the first of disabilities in the world. Although a motor spontaneous recovery is observed, around 50 to 70% of the hemiparetic upper extremity present alterations of upper extremity, limiting the performance of daily activities even after 2 to 4 years of strokes. More recently used in neurological rehabilitation, the ability to promote sensory-motor facilitation is given to the Elastic Tape (ET). However, its safety and efficacy in the treatment of post-stroke individuals still require further investigation. Thus, the objective of this project is to evaluate the immediate effects of ET, applied to the paretic shoulder on proprioception during movements of abduction and flexion of the shoulder and muscle activation and kinematic variables for the reaching in chronic hemiparetic. Fifteen subjects with chronic hemiparesis will participate these crossover sham-controlled trial. Participants will be randomized into two condition: elastic tape (ET) followed by sham tape (ST- strapping) or ST followed by ET. One month of washout period was considered. The motor impairment and the dominance before stroke will be evaluated by Fugl-Meyer scale and the Inventory Side dominance of Edinburgh, respectively. ET will apply deltoid (anterior, middle and posterior). Assessment before and after the application of ET will be performed. For proprioception assessment (joint position sense) will be evaluated using a dynamometer. Absolute error for shoulder abduction and flexion at the 30° and 60° was calculated. For the assessment of motor performance in a functional task (reach a glass of water), spatio-temporal parameters (total duration of the motion, peak velocity, time to peak velocity) and three-dimensional joint kinematics of the trunk, scapula, shoulder, and elbow (total range of motion, joint angle maximum and minimum) will be used. Concomitantly, bilateral activation of the deltoid (anterior, middle and posterior), trapezius (upper and lower), serratus anterior and pectoral major will be assessed by electromyography during reach. The following electromyographic variables will be analyzed: activation amplitude, muscle onset and maximum and minimum activation. For statistical analysis, the normality and homogeneity tests will be applied. If the variables have a distribution considered normal and homogeneous, Two-way ANOVA with repeated measures gift will be applied. Otherwise it will be applied to non-parametric statistics Friedman. Will be considered a 0.05 significance level for all statistical tests.

NCT ID: NCT02389608 Completed - STROKE Clinical Trials

The Immediate Effect of Electrical Stimulation Transcranial Direct Current (tDCS) Associated With the Use of FES, in Muscle Activity of the Tibialis Anterior Muscle, Balance and Plantar Pressure Distribution of Individuals With Hemiparesis Due to Stroke

Start date: January 2015
Phase: Phase 1/Phase 2
Study type: Interventional

Background: Transcranial direct current stimulation (tDCS) is currently considered a beneficial method for patients with neurological problems due to the modulation of cortex activity as well as the enhancement and prolongation of functional gains achieved during physical therapy. Purpose: The aim of the proposed study is to evaluate the immediate effects of a session of tDCS over the primary motor cortex combined with functional electrical simulation (FES) on electrical activity of the tibialis anterior muscle, balance and distribution of plantar pressure in individuals with hemiparesis stemming from a stroke. A further aim is to determine whether the effects of the combination of both stimulation methods are better than those achieved when each method is employed alone. Methods/design: A randomized, double-blind, crossover, cross-sectional study will be conducted involving 30 stroke survivors with hemiparesis who meet the eligibility criteria. Evaluations will involve an identification and screening chart, the classification of motor impairment using the Fugl-Meyer Scale, the determination of spasticity of the triceps surae muscle (modified Ashworth scale), electromyography of the tibialis anterior muscle, static balance and cognitive dual-task balance (stabilometry) and plantar pressure. After the initial evaluations, the participants will undergo four interventions: 1) anodal tDCS + placebo FES + active tibialis anterior contraction; 2) placebo tDCS + active FES + active tibialis anterior contraction; 3) anodal tDCS + active FES + active tibialis anterior contraction; and 4) placebo tDCS + placebo FES placebo + active tibialis anterior contraction. tDCS will be administered over the primary motor cortex and FES will be administered over the tibialis anterior muscle. The order of the different protocols will be randomized and both the evaluator and patients will be blinded to which protocol is being administered.

NCT ID: NCT02389582 Completed - Coronary Disease Clinical Trials

Effects of Low Molecular Weight Heparin Versus Dabigatran on Platelet Aggregation in Patients With Stable Coronary Artery Disease

Start date: May 2014
Phase: Phase 4
Study type: Interventional

Anticoagulation with heparin is indicated in several situations, such as acute coronary disease (in combination with antiplatelet therapy) for the prevention and treatment of venous thromboembolism and situations with high risk of thromboembolism. Recently, the latest trials on anticoagulation for stroke prevention on atrial fibrillation have shown an increased risk for acute mycardial infarction on patients submitted to new oral anticoagulants, such as dabigatran. The mechanism is still unclear, however, in this context, some previous studies about interaction between anticoagulants ( mainly heparin) and platelet aggregation have shown conflicting results: while some suggest an inhibitory effect of heparin on platelet function, others suggest that heparin could promote an increase in platelet activation. The present study aims to assess the effects of the LMWH Enoxaparin and direct thrombin inhibitor, Dabigatran, on platelet aggregation, studied and compared by different methods in patients with chronic coronary artery disease (CAD).

NCT ID: NCT02389569 Completed - Dental Caries Clinical Trials

Clinical Study of Biosilicate Under Resin Composite Restorations in Caries Affected Teeth

Start date: n/a
Phase: N/A
Study type: Interventional

This study aimed to evaluate the clinical performance of a novel vitro-ceramic biomaterial (Biosilicate®) as treatment of caries-affected dentin in posterior resin restorations. A total of 94 restorations of 66 participants were selected and assigned at random into four groups: 1 (Biosilicate / Two-step etch and rinse system), 2 (Control / Two-step etch and rinse system), 3 (Biosilicate / Two-step self-etching system) and 4 (Control / Two-step self-etching system). Two operators carried out the adhesive protocols and restored the cavities with a nano-hybrid resin composite (IPS Empress, Ivoclar) using the incremental technique. Participants were recalled at one week, 6, 12 and 18 months for clinical evaluation performed by two blinders and calibrated examiners according FDI criteria.

NCT ID: NCT02387567 Completed - Clinical trials for Chronic Low Back Pain

Paraspinal Block in Nonspecific Low Back Pain

Start date: January 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate the effects of a treatment involving the application of lidocaine injected on the low back area for pain control. The study will compare this form of treatment with other options such as physical exercises or pain killer medication, different measurements are going to be used to quantify the response to each of these treatments.

NCT ID: NCT02387528 Completed - Burnout Syndrome Clinical Trials

Efficacy of a Mindfulness-Based Intervention Versus Relaxation in Primary Care Burnout Providers.

MINDFULNESS
Start date: September 2014
Phase: N/A
Study type: Interventional

The prevalence of the Burnout Syndrome (BS) or symptoms among Primary Health Care (PHC) providers is high and can affect their quality of life and clinical results. Mindfulness-based interventions (MBI) have been tested as promising interventions to manage chronic stress and BS in PHC providers. The main goal of this study was to compare the efficacy of an eight week MBI (Group 1 or G1) on burnout symptoms in Brazilian PHC providers, compared to a briefer, four-week relaxation-based intervention (Group 2 or G2) and to a waiting list control group (Group 3 or G3). The initial hypothesis was that the MBI is superior to relaxation and to the waiting list group. A non-randomized controlled trial was performed, with mixed-methods evaluation (qualitative and quantitative).

NCT ID: NCT02386449 Completed - Bowel Preparation Clinical Trials

A Study Comparing Picoprep With Mannitol and Bisacodyl for Colon Cleansing in Preparation for Colonoscopy

CLEAR PREP
Start date: February 2015
Phase: Phase 4
Study type: Interventional

This is a randomized, controlled, parallel group, assessor-blinded study to compare two colon cleansing preparations for colonoscopy. Subjects meeting all inclusion and exclusion criteria will be randomized and assigned to one of two study groups: Group I (PicoPrep) or Group II (Mannitol). In Group I, subjects will take one sachet of PicoPrep on the day before colonoscopy, and another sachet on the day of colonoscopy. In Group II, subjects will take Bisacodyl on the day before colonoscopy, and Mannitol on the day of colonoscopy.

NCT ID: NCT02384603 Completed - Fibromyalgia Clinical Trials

Effects of Physical Therapy in Pain and Posture of Fibromyalgia Patients

Start date: February 2015
Phase: N/A
Study type: Interventional

The aim of this study is to compare the effects of two physiotherapeutic treatments of fibromyalgia: global postural reeducation associated with cognitive behavioral therapy and segmental muscle stretching exercises associated with cognitive behavioral therapy.

NCT ID: NCT02384408 Completed - Menopause Clinical Trials

Hormone Replacement Therapy on the Postmenopausal Endometrium

Start date: November 2014
Phase: Phase 4
Study type: Interventional

Healthy postmenopausal women, amenorrheic for 1-10 years, aged 45-60 years and in use of follicle stimulating hormone > 30 mille-International unit/milliliters (mIU/mL), will participate in the study. All women will be informed by a physician of the risks and possible benefits of Hormone Replacement Therapy (HRT). The continuous combined treatment with drospirenone 2 mg and 17β-estradiol 1 mg or tibolone 1.25 mg will be administered for a 24-week period. Transvaginal ultrasound was performed to evaluate the thickness of the endometrium at baseline. At study end-point, an endometrial biopsy will be performed with a Pipelle endometrial sampler to examine histological and immunohistochemical parameters. Immunohistochemical detection of Bcl-2 protein, estrogen and progesterone receptors will be performed in stroma and glandular epithelium.