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Stroke clinical trials

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NCT ID: NCT05976087 Recruiting - Stroke Clinical Trials

Improving Grasp Function in People With Sensorimotor Impairments by Combining Electrical Stimulation With a Robotic Hand Orthosis

SENSIBLE-EXO
Start date: July 1, 2023
Phase: N/A
Study type: Interventional

Hand motor and sensory impairments resulting from neurological disorders or injuries affect more than 50 million individuals worldwide. Conditions such as stroke, spinal cord injury (SCI), and traumatic brain injury (TBI) can cause long-term hand impairments, greatly impacting daily activities and social integration. Since traditional physiotherapy has limited effectiveness in rehabilitation, assistive devices helping in performing in daily activities have emerged as a necessary solution. Soft exoskeletons offer advantages as they are more comfortable and adaptable for the user, but they often struggle to generate sufficient force. On the other hand, electrical stimulation garments, like e-sleeves, show promise by stimulating nerves and muscles in the forearm. However, achieving precise and stable movement control remains challenging due to difficulties in electrode placement for targeted stimulation. Furthermore, none of the currently available devices are capable of artificially restoring lost sensation in users' hands, limiting their ability to manipulate with fragile objects. Recognizing these limitations, our study proposes a solution that combines a standard hand soft exoskeleton with: (i) electrical stimulation to the fingers' flexor and extensor muscles to generate artificial muscle contractions synchronized with the exoskeleton motion, compensating for the lack of gripping force, and (ii) electrical stimulation to the nerves to artificially restore the lost sensation of touch, enabling users to receive feedback on the force they are applying when interacting with the environment. The investigators refer to this proposed combination as Sensible-Exo. To achieve this goal, our project aims to evaluate the functional improvements in assistive and rehabilitative scenarios using SensoExo in comparison to use only the exoskeleton or having no support at all. The exoskeleton will be coupled with an electrical stimulating sleeve capable of delivering non-invasive electrical stimulation in the form of Functional Electrical Stimulation (FES) and Transcutaneous Electrical Nerve Stimulation (TENS). A glove with embedded force and bending sensors will be used to modulate the electrical stimulation. Additionally, apart from studying the enhancement of functional tasks, the investigators will explore improvements in body perception, representation, and multi-sensory integration. Indeed, the investigators also aim at identifying the way patients perceive their body by means of ad-hoc virtual reality assessments that has been developed. Before each assessment patient will perform some predefined movement in virtual reality to familiarize with it and increase embodiment. During the study, participants will perform a range of tasks based on their residual abilities, including motor tasks (e.g., grab and release, Toronto Rehabilitation Institute Hand Function Test, grip force regulation test, virtual egg test), cognitive tasks (dual tasks), and assessments of body representation and perception. Some of these tasks will be conducted in Virtual Reality environments, both with and without active stimulation.

NCT ID: NCT05974111 Recruiting - Ischemic Stroke Clinical Trials

COAgulation Disorders in Ischaemic and Haemorrhagic Stroke

COADIHS
Start date: May 2, 2023
Phase:
Study type: Observational

In this study the investigators will assess both procoagulant and anticoagulant pathways using thrombin generation and platelet function tests; as well as neuronal ischemia using cell free DNA in all patients presenting with ischaemic and haemorrhagic stroke (including aneurysmal subarachnoid haemorraghe). Also the cross-talk between inflammation and thrombosis, so-called thrombo-inflammation is further investigated. As such the investigators aim to characterise the patient's coagulation profile before administration of any treatment. By assessing these pathways the investigators strive to detect specific markers to predict vital and functional outcome at 3 months in these patients. Finally the investigators may provide new pathophysiological insights in the course of disease following these events that can possibly improve future therapeutic strategies.

NCT ID: NCT05973058 Completed - Stroke Clinical Trials

Psychometric Properties of Motor Recovery Assessment Scales for Stroke

Start date: March 5, 2023
Phase:
Study type: Observational

Stroke is a common global health-care problem that is serious and disabling. In high-income countries, stroke is the third most common cause of death and is the main cause of acquired adult disability. The most common and widely recognised impairment caused by stroke is motor impairment, in function. Measuring motor recovery can assist the clinician in diagnosis, selection of the most appropriate therapy, and outcome measurement. To date, different functional scales measuring motor recovery have been developed and used in stroke. However, only a few are specifically designed for stroke patients. The Fugl-Meyer assessment (FMA) and The Stroke Rehabilitation Assessment of Movement(STREAM) and Rivermead Motor Assessment(RMA) are the most commonly used for measuring motor recovery in stroke patients. To be clinically useful, a scale must be scientifically sound in terms of 3 basic psychometric properties: reliability, validity, and responsiveness. The objective of this study will be to compare the three clinical motor recovery measures, The Fugl-Meyer assessment motor domain (FMA-M) and mobility subscale of The Stroke Rehabilitation Assessment of Movement (STREAM) and Rivermead Motor Assessment (RMA), in stroke patients with a broad range of neurological and functional impairment from the acute stage up to 120 days after onset. stroke patients will be followed up prospectively with the 3 measures 30,60,90, and 120 days after stroke onset (DAS). Reliability (interrater reliability and internal consistency) and validity (concurrent validity, convergent validity, and predictive validity) of each measure will be examined. A comparison of the responsiveness of each of the 3 measures will be made on the basis of the entire group of patients. the degrees of responsiveness of the 3 balance measures will be calculated on the basis of the changes occurring between 30 to 60, 60 to90, and 90 to 120, and 30 to 120 DAS. Collected data will be analyzed by using spss 21.

NCT ID: NCT05970406 Enrolling by invitation - Clinical trials for Dysphagia Following Cerebrovascular Accident

High Intensity Dysphagia Rehab for Acute Ischemic Stroke Patients

Start date: November 30, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to determine a standardized protocol for swallowing therapy and this protocol's effects on recovery after a stroke

NCT ID: NCT05970367 Recruiting - Stroke Clinical Trials

Intensive Motor Rehabilitation With Technology for Patients With Central Neurological Disease

INTeRAcT
Start date: July 10, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

This project will consist of 1 large clinical trial with 2 core concepts: (1) Clinical benefits of an intensive rehabilitation programme using advanced technology, compared to the control group; (2) A full health economic evaluation combined with model-based estimation of costs and benefits.

NCT ID: NCT05969548 Recruiting - Stroke Clinical Trials

pBFS-guided cTBS at Different Doses for Aphasia After Stroke

Start date: September 22, 2023
Phase: N/A
Study type: Interventional

The objective of this trial is to evaluate the effectiveness and safeness of different doses of continuous Theta Burst Stimulation (cTBS) over the right Superior Frontal Gyrus (SFG), guided by personalized Brain Function Sector (pBFS) technology, on language function recovery in patients with post-stroke aphasia.

NCT ID: NCT05969249 Not yet recruiting - Stroke Clinical Trials

Vibration Approach Functions in Upper Extremities for People After Stroke

Start date: August 7, 2023
Phase: N/A
Study type: Interventional

This study will develop a vibration rehabilitation system for the upper extremities and provide strong evidence-based information regarding the mechanism and rehabilitation of stroke patients through the application of vibration by comparing the benefits of its clinical outcome with those of traditional rehabilitation methods. Based on these findings, we could create precision vibration exercise programs to improve the health of stroke patients.

NCT ID: NCT05968248 Not yet recruiting - Stroke Sequelae Clinical Trials

Efficacy and Safety of Deep Brain Stimulation in Mesencephalic Locomotor Region(MLR) for Poststroke Hemiplegia

Start date: September 10, 2023
Phase: N/A
Study type: Interventional

Abstract: Background: The leftover movement disorder of stroke patients is one of the main causes of disability, and there is still no specific solution. Studies have shown that the improvement of movement disorder symptoms in patients receiving DBS is a potential therapy. treatment approach. However, at present, there are few large-sample studies in this area at home and abroad, which cannot well reveal its actual therapeutic effect and safety, and do not fully understand its potential neural mechanisms, so it is impossible to form a unified and standardized treatment standard, which limits its wide application in clinical practice. Objectives: This study aimed to determine the efficacy and safety of hemiplegia recovery after deep brain electrical stimulation in stroke patients with hemiplegia. Methods/Design: This was a double-blind randomized cross-over controlled pilot study in which 62 patients were assigned to receive deep brain stimulation (DBS) and randomized into DBS and control groups using a randomized controlled study approach, DBS group One month after the operation, electrical stimulation was started, and the control group was given sham stimulation treatment. After 3 and 6 months of follow-up, all the machines were turned off. After a 2-week washout period, the control group was turned on, but the DBS group was given sham stimulation. After the 9th and 12th month of follow-up, all patients were given start-up treatment, and neuroimaging and various post-stroke motor-related scores were performed for data collection and analysis. Discussion: The investigators propose a research design and rationale to explore the effectiveness and safety of DBS in patients with post-stroke hemiplegia, and provide evidence and reference for DBS in the treatment of post-stroke dyskinesia. Study limitations are related to the small sample size and short study time period.

NCT ID: NCT05967728 Not yet recruiting - Ischemic Stroke Clinical Trials

Testing of a System for Remote Ischemic Conditioning in Cerebral Small Vessel Disease and Pre-hospital Stroke Care

TRIC-SVD
Start date: September 1, 2024
Phase: Phase 2
Study type: Interventional

This early phase trial will address the following key objectives: 1. Completion of initial safety and tolerability testing of our viable prototype for remote ischemic conditioning (RIC) with patients with (a) CSVD and (b) acute ischemic stroke. 2. Usability testing of the prototype with patients and healthcare professionals, with further optimization. Approximately 24 patients with CSVD will be recruited to use the RIC device daily for 60 days and provide feedback. They will be randomized in a 1:1 ratio to either true RIC therapy or sham control for the first 30 days, after which the sham group will cross over to receive true RIC for the remaining 30 days. Feasibility testing will be done in the mobile stroke unit on up to 10 patients with acute ischemic stroke. An additional 10 stroke physicians and paramedics will conduct device usability testing and provide feedback.

NCT ID: NCT05965713 Not yet recruiting - Stroke Clinical Trials

National Fully Remote Use of IpsiHand Device in Hemiparetic Stroke

Start date: October 1, 2023
Phase: N/A
Study type: Interventional

The goal of this study is to define the efficacy of fully remote home-based BCI therapy in chronic hemiparetic subcortical stroke patients. A randomized controlled study using the integrated remote BCI system will be tested against standard exercise therapy to determine the efficacy of motor improvement in chronic stroke patients with an upper extremity hemiparesis. Specifically, the integrated BCI system will include 1) the remote screening and motor assessment system for the upper extremity and 2) the BCI-controlled robotic hand exoskeleton (i.e. IpsiHand).