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Stroke Sequelae clinical trials

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NCT ID: NCT04152616 Recruiting - Stroke Sequelae Clinical Trials

Mechanisms of Balance Disorders in a Seated Position Following a Stroke

HEMISEAT
Start date: September 2020
Phase: N/A
Study type: Interventional

One of the causes of disability in stroke patients is postural disturbances that result in postural asymmetry in the standing position, characterized during an evaluation on a force platform by a greater displacement of the center of pressure towards the lesion side and thus by a greater percentage of weight on the lower limb (Weight -Bearing Asymmetry (WBA)). Today, the mechanisms of balance disorders in standing position are better understood. Indeed, in addition to sensory and motor deficits, spatial cognitive disorders also contribute to these postural disturbances, particularly in right brain damage stroke. This would be the reason why patients with right brain damage have a more precarious and time-consuming balance to re-educate than patients with lesions located in the left hemisphere. Postural disturbances can also result in a disturbance of balance in the sitting position, which is a poor prognosis for the acquisition of transfers, standing and walking. To date, seated postural disturbances are not perfectly described with many differences in the explanatory mechanisms found in the literature. Thus, some people notice a more pronounced asymmetry on the medio-lateral plane while others find a more pronounced imbalance at the antero-posterior plane. Sitting posture disorders benefit from few instrumental measurement tools outside clinical measurement scales. A very wide variety of evaluation methods by instrumental measurements are proposed and not validated. Sensor pad, which are usually used to adjust the bases of pressure ulcer patients, may be useful in quantifying the postural balance. But since the involvement of the head and trunk in the sitting posture is well documented in the literature, the addition of an evaluation of the position of the trunk and head seems essential. To our knowledge, no author has proposed to quantify sitting balance disorders by combining a measure of support asymmetry by taking into account the posture of the trunk with that of the head.

NCT ID: NCT04130646 Active, not recruiting - Stroke Clinical Trials

Noninvasive VNS to Facilitate Excitability in Motor Cortex

Start date: March 15, 2020
Phase: N/A
Study type: Interventional

Transcranial Magnetic Stimulation (TMS) positively influences motor rehabilitation in stroke recovery. Transcutaneous auricular vagus nerve stimulation (taVNS) has shown effects on cortical plasticity. We investigate whether combination of TMS and taVNS is more effective at motor cortex excitability than either modality alone.

NCT ID: NCT04127669 Completed - Stroke Sequelae Clinical Trials

Study Evaluating Efficacy and Safety of OSU6162 in the Treatment of Residual Symptoms After Stroke

OSU6162DB003
Start date: March 20, 2017
Phase: Phase 2
Study type: Interventional

Following stroke, a recovery process is promptly initiated, which leads to a partial rehabilitation. However, a number of disabling residual symptoms may persist for years and include mental fatigue, depression, cognitive deficits, neurological problems and more. In the lack of an effective treatment these symptoms will lead to major consequences for the individual and the surrounding society. OSU6162 has in earlier clinical studies of stroke patients shown evidence of a favorable effect on residual symptoms, especially mental fatigue, together with a mild side effect profile. In this phase II, randomized, placebo-controlled, two-armed study, a 16 week OSU6162 treatment will be compared to an equally long placebo treatment in patients with residual symptoms following stroke.

NCT ID: NCT04116190 Completed - Stroke Sequelae Clinical Trials

A Multidisciplinary Telerehabilitation for Stroke Patients

Start date: September 1, 2017
Phase: N/A
Study type: Interventional

Objective: Evaluate the feasibility of a multidisciplinary telerehabilitation for chronic stroke patients. Design: Chronic stroke patients eligible for multidisciplinary rehabilitation funded by the Social Insurance Institution were enrolled between September 2017 and March 2018 in a consecutive basis to receive a mixed program of inpatient rehabilitation and telerehabilitation in their homes or a traditional inpatient rehabilitation only. Intervention: A rehabilitation course with a 3-day inpatient stay followed by an 8-week telerehabilitation period completed by 2-day evaluation stay in a rehab center. The control group received conventional multidisciplinary rehabilitation for two weeks in an inpatient setting. Outcome and measures: Change in the Finnish version of Functional Status Questionnaire (FSQFin), the World Health Organization Quality of Life - Short version (WHOQOL-Bref), the Barthel Index, the Beck Depression Inventory (BDI21), and the Goal Attainment Scale (GAS) and a patient satisfaction questionnaire.

NCT ID: NCT04113525 Terminated - Stroke Clinical Trials

Transcutaneous Spinal and Peripheral Stimulation and Wrist Robotic Therapy for Patients With Spastic Stroke

Start date: September 24, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate if two courses of five consecutive sessions of noninvasive spinal stimulation paired with peripheral nerve stimulation at the forearm provided by an investigational device (Doublestimâ„¢/ MyoRegulatorâ„¢ System - PathMaker Neurosystems Inc.) are able to improve wrist stiffness and motor function, when combined with intensive robotic wrist training program in participants with chronic spastic hemiparesis after stroke.

NCT ID: NCT04000971 Active, not recruiting - Stroke Clinical Trials

Coordinated, Collaborative, Comprehensive, Family-based, Integrated, Technology-enabled Stroke Care

C3FIT
Start date: February 25, 2020
Phase: N/A
Study type: Interventional

Stroke is the 5th leading cause of death and the leading cause of adult disability in the United States (US). Stroke is a complex disease with multiple interacting risk factors (including genetic, high blood pressure and cholesterol, and lifestyle factors like smoking, diet, and exercise) that lead to initial and recurrent stroke. Up to 90% of stroke survivors have some functional deficit that impacts both physical and mental health. Scientific evidence that identifies the best stroke care delivery design is lacking. We completed a three-year, Centers for Medicare & Medicaid Services (CMS) Health Care Innovation Award that tested a new stroke care design called an Integrated Practice Unit (IPU). This IPU was developed through stakeholder input from patients, caregivers, nurses, stroke specialists, rehabilitation specialists, patient advocacy groups, payers, and technology companies. This IPU design was associated with decreased hospital length of stay, readmissions, and stroke recurrence, as well as lower cost. Based on the CMS study, a larger, pragmatic trial was developed that is called C3FIT (Coordinated, Collaborative, Comprehensive, Family-based, Integrated, and Technology-enabled Stroke Care). C3FIT will randomly assign approximately 22 US hospital sites to continue Joint Commission-certified Comprehensive/Primary (CSC/PSC) design or to the novel Integrated Stroke Practice Unit (ISPU) design for stroke care. C3FIT's ISPU uses team-based, enhanced collaboration (called Stroke Central) and follows patients from presentation at the Emergency Department (ED) through 12-months post-discharge (called Stroke Mobile). Stroke Mobile includes a nurse and lay health educator team who visit patients and caregivers at home or at a rehabilitation or skilled nursing facility to assess function and quality of life using telehealth technology to facilitate access to multiple providers. Results from C3FIT will provide high quality scientific evidence to determine the best stroke care design that ensures positive health for patients and caregivers.

NCT ID: NCT03913286 Active, not recruiting - Stroke Clinical Trials

Neuromotor Prosthetic to Treat Stroke-Related Paresis

Cortimo
Start date: May 1, 2019
Phase: N/A
Study type: Interventional

The purpose of the research is to develop a new medical device prototype to restore functional movement of an arm made weak due to a chronic stroke

NCT ID: NCT03865173 Active, not recruiting - Stroke Clinical Trials

Post-stroke Pathway: Analysis and Link With One Year Sequelae in a French Cohort of Stroke Patients

PAPASéPA
Start date: November 18, 2019
Phase:
Study type: Observational

The link between post-stroke pathways and patient sequelae have not yet been clearly defined. The main purpose is to identify the post-stroke life pathways components associated with sequalae at 3 months and 1 year after the acute stroke episode.

NCT ID: NCT03860662 Completed - Stroke Sequelae Clinical Trials

The Effect of Oral Baclofen and Botulinum Toxin Treatments in Hemiplegic Spasticity on the Nociceptive Flexor Reflex

Start date: May 26, 2018
Phase: Phase 4
Study type: Interventional

The purpose of this thesis is to research the effect of oral baclofen treatment and botulinum toxin injection treatments over the electromyographic nociceptive flexor reflex (NFR) threshold in hemiplegic patients with spasticity. The results of the study evaluated the Modified Ashworth Scale, joint range of motion, muscle strength, Brunnstrom stages, Barthel daily life activities index, electromyographic nociceptive flexor reflex (NFR) threshold.

NCT ID: NCT03755063 Terminated - Stroke Sequelae Clinical Trials

Recovernow: Tablet-Based Speech Therapy For Post-Stroke Aphasia

Start date: November 13, 2019
Phase: N/A
Study type: Interventional

RECOVERNOW is A MULTICENTRE PHASE II RANDOMIZED CONTROLLED TRIAL OF EARLY MOBILE TABLET-BASED SPEECH THERAPY FOR ACUTE STROKE PATIENTS WITH APHASIA. Using a novel futility design, investigators will randomize acute care in-patients with stroke to mobile tablet-based speech therapy applications vs the standard of care. Primary outcome is improvement in the Western Aphasia Battery Aphasia (WAB-R) Overall Study Aim: The primary study aim is to determine the futility and potential efficacy of mobile tablet-based speech therapy for post stroke aphasia. Primary Endpoint: The primary outcome measure is change in the Aphasia quotient (AQ) from the WAB-R at 90 days. The WAB-R is a standardized aphasia battery. The AQ is calculated from four language sub-tests measuring spontaneous speech, word comprehension, repetition, and word finding.) Secondary Endpoints: The results of the cost-effectiveness analysis will be expressed as the incremental cost per one-unit improvement in AQ and the incremental cost per one quality-adjusted life year (QALY) gained. Population: 226 participants will be enrolled over 3 years. Males and females, >18 years of age, with diagnosis of acute ischemic/hemorrhagic stroke confirmed by routine head computerized tomography (CT) scan with mild to moderate aphasia. Phase: II Number of Sites: It is anticipated that this will be a multi-center study, with the following facilities participating: The Ottawa Hospital, Ottawa, ON, Foothills Medical Centre, Calgary, Alberta and Toronto Western Hospital. Protocol Therapy: Patients will be randomized 1:1 to receive either tablets with speech therapy apps (intervention group) or standard of care. Study Duration: It is estimated that recruitment will take place over 3 years in the three participating centers. Subject Participation Duration: All patients will be assessed clinically at baseline and Day 90 (+/-10).