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Stroke clinical trials

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NCT ID: NCT05112094 Recruiting - Stroke Clinical Trials

Peripheral Magnetic Stimulation to Treat Patient With Post-stroke Shoulder-hand Syndrome

Start date: August 1, 2021
Phase: N/A
Study type: Interventional

Shoulder-hand syndrome is a common complication following stroke, constituting of excessive pain, swelling, heat, limited range of motion, and trophic change of the affected limbs. It not only has an extensive negative impact on both physical and psychological aspects of a stroke patient's well-being, but also impose burden on the health care system and the patient's family. Despite its relatively high incidence, there is neither well-established treatment protocol, nor high quality evidence for a single effective treatment. The objective of the present study is to investigate the efficacy, including pain, spasticity, and subluxation reduction, muscle strengthening, and shoulder range of motion improvement, of high-intensity peripheral magnetic stimulation generated by the super-inductive system to treat patients with post-stroke shoulder-hand syndrome.

NCT ID: NCT05111951 Completed - Stroke Clinical Trials

Mobile Health to Promote Physical Activity Post Stroke

ENAbLE-Swe
Start date: November 1, 2021
Phase: N/A
Study type: Interventional

Support for physical activity is necessary to sustain health and reduce the risk of stroke recurrence after stroke or transient ischemic attack (TIA). Still, rehabilitation services are not available to many of those who potentially would benefit from such services largely due to barriers related to accessibility. While mobile health is a promising strategy to support physical activity, there is a gap in knowledge regarding the implementation of technology that meet the needs of people post stroke or TIA in order to foster adherence and engagement in physical activity. This project therefore seeks to improve health and reduce the risk of recurrent stroke among people post stroke or TIA by increasing the access to physical activity through telehealth. The present project builds on experiences of telehealth-delivered physical activity in Australia where restricted access to health-care services is a longstanding problem. Collaborating researchers in Australia have developed a telehealth program (i-REBOUND- Let's get moving) which has been designed and tested in collaboration with end users, through a series of feasibility and pilot studies. The i-REBOUND program provides support for physical activity through physical exercises supervised by a physiotherapist and behavior change techniques for physical activity (i.e. individual counseling, information, recommendations, goal-setting, self-monitoring and structured follow-ups) across 6 months. The intervention is delivered to people post stroke or TIA in their own homes via video-meeting. This study, which is conducted in Sweden, aims to evaluate if the i-REBOUND program supported by a new mobile application could be delivered as intended through a pilot randomized controlled trial in order to determine the feasibility and preliminary effects in people post stroke or TIA living in urban and rural regions of Sweden.

NCT ID: NCT05111821 Recruiting - Stroke Clinical Trials

Iron Chelation in the Prevention of Secondary Degeneration After Stroke

CHEL-IC
Start date: June 8, 2022
Phase: Phase 2
Study type: Interventional

Stroke is a major cause of disability over the world. While acute therapies have made huge progresses, the number of survivors leaving with clinical consequences of stroke is increasing. Beyond stroke itself, secondary neurodegeneration of disconnected areas, especially of central hubs such as the substantia nigra or the thalamus, could significantly impact the overall outcome of the patients. Data have identified iron accumulation within the disconnected areas as potentially accelerating neurodegeneration. In this research, the main objective is test whether long-term chelation through Deferiprone (Ferrirpox®, Chiesi) administered daily from 3-to-5 days following stroke to 6 months could avoid iron accumulation as measured with Magnetic resonance imaging (MRI) within disconnected areas (substantia nigra). MRI imaging methods such as the quantification of the transverse relaxation rate R2* provide highly correlated information to the histologically measured iron load

NCT ID: NCT05110300 Terminated - Stroke Clinical Trials

A Multisite Exploration of Balance Perturbations With and Without Body Weight Support

Start date: December 15, 2021
Phase: N/A
Study type: Interventional

ZeroG is an FDA-listed robotic body weight support system (BWSS). Mounted on an overhead track, patients are fitted in a harness system tethered to said track, and are able to practice gait and balance activities without the risk of falling. This compensates for ineffective postural control permitting intensive therapy sessions earlier in recovery. The purpose of this study is to determine if inducing effective and safe balance perturbations during standing and walking in the BWSS more effectively improve postural control than the BWSS without perturbations. The target population are those patients in the post-acute phase of stroke admitted for inpatient rehabilitation of balance impairments. Site investigators and/or research staff will obtain names of potential subjects from internal reporting identifying inpatients who may qualify for the study based on the inclusion criteria. Trained site investigators will meet with potential subjects to explain the study, complete a screening interview for exclusion and inclusion criteria, answer any questions, obtain informed consent and HIPAA authorization, and schedule the study therapy sessions involving the protocol. Based on the randomization scheme provided by the lead site, consented subjects will be randomized to either the BWSS with perturbations (BWSS-P) or standard BWSS control without perturbations. Subjects will perform 2 to 6 sessions in their designated intervention using a structured protocol for each session. To compare differences between treatment groups, outcome measures will be collected at baseline before any BWSS sessions are performed and within 48 hours after completing the final treatment session.

NCT ID: NCT05110105 Active, not recruiting - Stroke Clinical Trials

Exploring the Effect of Interactive Board Game Health Education on Improving Stroke Knowledge and Health Literacy in Community-Dwelling Adults

Start date: November 8, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to explore the effectiveness between interactive board game health education and conventional health education in improving community-dwelling adults' stroke knowledge and self-reported stroke health literacy, including risk factors, symptoms, acute management of stroke, and 6 aspects of self-reported stroke health literacy. The intervention group will receive an interactive board game in a group (2~6 individuals), while the control group was assigned to read the health education flier and watching the stroke prevention video. The follow-up period was set to be four weeks after the intervention, both control group, and intervention group.

NCT ID: NCT05107206 Recruiting - Clinical trials for Acute Ischemic Stroke

Envi™-SR Randomized Controlled Trial for Endovascular Treatment of Ischemic Stroke

ENVI RCT
Start date: June 23, 2022
Phase: N/A
Study type: Interventional

The study objective is to examine and compare clinical outcomes, as measured by Modified Rankin Scale (mRS) at 90 days (± 15 days) post treatment, and related performance characteristics of the Envi™-SR and concurrent parallel Control Devices currently cleared by the U.S. FDA for treatment of stroke.

NCT ID: NCT05106595 Completed - Stroke, Acute Clinical Trials

Bimanual Arm Training in Acute Stroke

Start date: May 10, 2022
Phase:
Study type: Observational [Patient Registry]

Recent studies have shown that completing bilateral simultaneous movements during upper extremity practice may result in facilitation of coactivation and interhemispheric activation of both the ipsilesional and contralesional brain areas, with one limb entraining the other and enabling the limbs to function as a unit. Other research has proposed that the use of virtual-reality (VR) activities during treatment sessions can improve upper extremity function following stroke as it is motivating, challenging, offers external feedback that may facilitate motor learning, and allows for the "high-intensity, repetitious practice necessary to drive recovery". Coupling bilateral simultaneous upper extremity movement and virtual-reality activities is the Bimanual Arm Trainer (BAT), a non-powered mechanical device by which the non-paretic upper extremity moves the paretic arm. The purpose of this study is to determine the effectiveness of the Bimanual Arm Trainer (BAT) compared to traditional occupational therapy treatment sessions as these relate to upper extremity functional return following stroke, as measured by scores on the Action Research Arm Test (ARAT) and Upper Extremity Fugl-Meyer Assessment (UE-FMA) measures. The investigators plan to use retrospective data for a pre-implementation group, comparing this data to prospectively collected post-implementation data. ARAT scores are routinely collected and will be used for comparison between groups. UE-FMA measures are commonly used in this area of research, and will be taken to provide additional context for the post-implementation group.

NCT ID: NCT05106140 Recruiting - Stroke Clinical Trials

Robotic Evaluations of Motor Learning During Stroke Neurorehabilitation

RELEARN
Start date: September 20, 2021
Phase:
Study type: Observational

The RELEARN trial is a a prospective longitudinal cohort study sampled by convenience. Stroke survivors and healthy control individuals will be recruited to analyze motor learning in the upper extremity and its neural basis in early stroke recovery.

NCT ID: NCT05104645 Recruiting - Clinical trials for Cerebral Vascular Accident

Analysis of the Psychometric Properties of Kinematic Parameters of Locomotion Measured by Inertial Units. Validation in Healthy Volunteers and Stroke Patients

KAPP-IMU
Start date: September 29, 2021
Phase: N/A
Study type: Interventional

Stroke is the leading cause of acquired disability in adults in France, and more than 500,000 French people are currently living with the after-effects. Hemiparesis, which is a partial deficit of motor or muscular control affecting the right or left half of the body, is the most frequent motor disorder after a stroke. Currently, the management and treatment of stroke patients consists of a combination of pharmacological treatments (drugs, botulinum toxin, etc.), the fitting of devices (orthoses, etc.) and rehabilitation (physical therapy, adapted physical activity, occupational therapy, etc.). According to the French National Authority for Health, motor rehabilitation after a stroke must meet 3 criteria: early, intensive and continuous. Functional evaluations (with validated measurement scales or analysis of locomotor activities) make it possible to monitor rehabilitation and to verify that the intensity is adapted to the patient's needs. To date, technological advances have yielded numerous gait analysis devices, ranging from motion capture platforms to inertial measurement units (IMU) and the use of motion platforms with integrated sensors. Different systems embedding an IMU on the foot, for example, answer these problems of analysis of walking in real situation. The IMUs record the movements and orientation of the foot in space; the data are then processed by algorithms to recognize the walking steps and calculate the spatiotemporal locomotion parameters. Additional IMUs positioned on the body can be added to this system in order to access a more precise analysis of locomotion, in particular by calculating the movements of the various joints of the lower limb. The validation of systems integrating IMUs must be done according to a precise method widely documented by the COSMIN recommendations (COnsensus-based Standards for the selection of health Measurement INstruments). This project will be carried out in two stages, the first of which will evaluate the safety and psychometric properties of the spatiotemporal parameters of the IMU devices in healthy subjects. If these properties (safety, reproducibility and validity) are considered to be in conformity, the second phase will be initiated. These same parameters will be evaluated during the rehabilitation of a cohort of patients who have suffered a stroke.

NCT ID: NCT05104593 Not yet recruiting - Stroke Clinical Trials

An Integrated Solution for Sustainable Care for Multimorbid Elderly Patients With Dementia

CAREPATH
Start date: January 1, 2024
Phase: N/A
Study type: Interventional

The CAREPATH will conduct Technical Validation and Usability (TVU) study by involving ≥ 45 target end users (16 patients with MCI or mild dementia with their informal caregivers and 16 healthcare professionals from various disciplines) and Clinical Investigation (CI) study involving ≥ 200 patients (≥ 100 users to pilot the CAREPATH platform and ≥ 100 patients as reference cases). Both of these pilot studies will be coordinated in four European countries (Spain, Romania, Germany and UK) with diverse health and social care systems, ICT landscape/digital maturity of healthcare provision and dementia national programs, which will allow for strengthening the evidence base on health outcomes and efficiency gains. The CAREPATH outcomes can be summarized as: 1. An Integrated Care Platform that jointly addresses multimorbidity, dementia and diminished intrinsic capacity and optimally manages healthcare interventions for its users (patients, informal caregiver, healthcare providers, etc). 2. Technical Validation and Usability (TVU) study involving over 45 users and Clinical Investigation (CI) involving over 200 patients that will be conducted in four European countries (Spain, Romania, Germany and UK) during two years and mobilizing the other necessary actors, such as caregivers and healthcare professionals, for the validation of healthcare interventions. 3. Dementia / Multimorbidity Guidelines that will be conceived for best healthcare delivery. 4. Health Economics Impact Assessment for healthcare cost effectiveness and care provision equalities. The incremental cost-effectiveness and the incremental cost-utility ratio would allow revealing the incremental cost (or the potential savings) per unit of benefit of switching from usual care to CAREPATH-an integrated patient-centred approach- in multimorbid elderly patients with dementia, and therefore, to determinate whether the CAREPATH approach would be considered as a cost-effective alternative.