Clinical Research Directory

Screening for Social Determinants of Health (SDOH) and Cognitive Function in Individuals With History of Stroke

Background: Stroke is the fifth leading cause of death in the United States. It is also a leading cause of disability. More than 70% of people who survive strokes have mental impairment or dementia. Medical factors, such as the severity of the stroke, affect whether a person will have mental impairment afterward. But social factors, such as education and ethnicity, seem to play a role as well. Researchers want to learn more about how social and lifestyle factors affect a person s chances of maintaining mental functions after a stroke. Objective: To better understand how social and lifestyle factors affect the risk of mental impairment after a stroke. Eligibility: People aged 18 years and older who had a stroke and a brain scan while they were enrolled in NIH Study 01N0007 (Natural History of Stroke Study). Design: Participants will have 1 study visit, by telephone. The call will last about 45 minutes. Participants will talk about their health since their stroke. They will answer questions about themselves. Topics will include: * Their race * Education * Ethnicity * Employment * Marital status * Residence address * Recent health history * Medical insurance They will have tests of their memory, attention, and language skills. They will repeat numbers and words forward and backward. Researchers will look at the data and imaging scans collected during participant s enrollment in NIH Study 01N0007. This data will include: * The hospital that first saw the participant at the time of their stroke. * The type of imaging that was first used then. * The primary diagnosis at admission. * Other medical details.

Assistance Delivery and Muscle Coordination

The experiment will be conducted with 15 chronic stroke survivors and 15 control subjects. Subjects will perform extension movements of the index finger of their more-impaired (stroke) or nondominant (control) hand under two different assistance types: end-effector assistance and exotendon assistance. For each assistance type, unassisted movements will be performed before and after the assistance. Subjects will be randomly assigned into two groups (A and B), who will receive the assistance in a different order. The finger movements and muscle activation patterns will be recorded during movements.

Neuromuscular Electrical Stimulation and Voluntary Muscle Contraction in Chronic Hemiplegic Stroke Patients

This single-blinded randomized controlled trial will be conducted at the Physical Therapy Department of the University of Lahore Teaching Hospital after approval from the Institute Research Ethics Board. Eligible participants will be recruited and randomly allocated into two groups by lottery method: Group A (control group) receiving conventional physical therapy, and Group B (experimental group) receiving neuromuscular electrical stimulation (NEMS) combined with voluntary muscle contraction. NEMS will be applied to the tibialis anterior, extensor hallucis longus, and extensor digitorum longus with standard stimulation parameters, while participants perform active dorsiflexion during stimulation. The assessor will remain blinded to group allocation. Outcome measures including spasticity (Modified Ashworth Scale), active range of motion (goniometer), and muscle strength (manual muscle testing) will be evaluated at baseline, 6 weeks, and 12 weeks.

Drug Eluting Stenting and Aggressive Medical Treatment for Preventing Recurrent Stroke in Intracranial Atherosclerotic Disease Trial

The aim of DREAM-PRIDE is to evaluate whether implantation of drug-eluting stent (DES) combined with aggressive medical treatment is more efficacious in prevention of 1-year stroke recurrence than standard medical treatment alone for symptomatic intracranial atherosclerotic disease.

EMG-Directed Virtual-Reality Training for Motor Stroke Rehabilitation

This study is testing whether rehabilitation using muscle activity signals can help improve arm and hand movement in people after stroke or spinal cord injury. In the main study, participants will use a virtual-reality feedback system that is controlled by surface electromyography (EMG). Surface EMG uses sensors placed on the skin to detect muscle activity. The feedback will help participants practise upper limb movements during rehabilitation. A related sub-study will run alongside the main study. In this sub-study, functional electrical stimulation will also be used to help activate muscles during training. The study will assess whether these rehabilitation approaches improve upper limb function. It will also explore whether changes in biological or movement-related markers are linked with recovery.

Assessing Transition Practices for Children With Disabilities: Pathways to a Successful Adulthood

Transition to adult care is a purposeful and structured movement of youth with complex disabilities from child centered to adult oriented services. This complex and potentially challenging period requires careful planning. The investigators aim to examine the transition practices in the University Hospital of Saint Etienne. The study employs a mixed methods approach, combining: * A retrospective evaluation : Analyzing transition data over a 10-year period. * A prospective qualitative study : Conducting semi-structured interviews with patients who have already transitioned within our clinic.

ZEPU-AI3 Lower Limb Feedback Robot Training Study

Lower limb motor dysfunction resulting from stroke, spinal cord injury, or other neurological disorders substantially limits mobility, independence, and quality of life. Robotic rehabilitation has emerged as a promising approach to provide intensive, repetitive, task-oriented training. The ZEPU-AI3 Lower Limb Feedback Training and Evaluation Robot is designed to deliver interactive lower limb training while providing real-time performance feedback. This pilot randomized controlled trial aims to evaluate the safety, efficacy, and feasibility of ZEPU-AI3-assisted rehabilitation combined with conventional rehabilitation compared with conventional rehabilitation alone in patients with lower limb motor dysfunction. The primary outcomes include safety, feasibility, and changes in lower limb motor function, gait performance, and functional mobility. The findings will provide preliminary evidence to support future large-scale clinical trials and the implementation of robotic rehabilitation in clinical practice.

Time Pressure Motor Training With Step Square Exercise on Stroke Patients

to investigate The Efficacy of Time Pressure motor rehabilitation with step square exercise (SEE) on decision making ability \& quality of life in stroke Patients

Muscle Coordination-Based Feedback for Stroke Rehabilitation

The purpose of this study is to compare two interventions currently used to improve gait and lower limb function in individuals with chronic stroke (i.e., high-intensity gait training and high-intensity gait training with functional electrical stimulation (FES)) with novel interventions based on the coordinated activity of multiple muscles, known as muscle synergies. To this end, the researchers will recruit chronic stroke patients to participate in training protocols according to the currently used rehabilitation programs as well as novel rehabilitation programs that provide real time feedback of muscle synergies using multichannel FES and visual feedback.

Behavioral Intervention and Guided Stepping Training Early Post-Stroke

Low daily steps and prolonged sedentary behavior are associated with reduced functional outcomes and quality of life in patients with stroke. The goal of this research project is to test the effect of increasing daily step counts and reducing sedentary time early after stroke, on functional mobility and global disability outcomes. The investigators aim to recruit 150 participants, aged 50 years and over, within three months of stroke onset, whom have recently returned or are returning home from hospital and are able to walk 5 meters with or without a gait aid. At baseline, demographic and stroke characteristics will be determined and documented. A battery of impairment, psychosocial, and functional measures will be completed. Step counts (primary outcome) and sedentary time will be determined from activPAL accelerometry. Following randomization, a sedentary behaviour change and guided stepping intervention (BIG STEPS) will be extended to the experimental arm (early BIG STEPS), the intervention will span 3 months, with final follow-up assessments every 90 days, until the final assessment at 12 months. The waitlist control group (delayed BIG STEPS) will receive the BIG STEPS intervention after a 6 month wait period. The primary outcome of this study is change in step counts from baseline to 3 months, measured with an activPAL accelerometer. Secondary outcomes include sedentary time, functional mobility, and walking endurance measured every 90 days for 12 months. Patient-reported mood, fatigue, and quality of life outcomes will also be assessed. The BIG STEPS program will allow individuals with stroke to take an active role in their recovery, encouraging engagement, autonomy and sustained health outcomes. The implementation of a waitlist RCT design allows for the evaluation the critical period for intervention delivery. The results of this trial will help inform future changes in best practice, reducing disability after stroke and improving patient quality of life.

Tracking Neural Synergies After Stroke.

The purpose of this study is to identify neural muscle synergies of patients post-stroke and track them during an inpatient acute rehabilitation. To this end, the researchers will use an innovative approach based on the identification of large populations of motor units from recordings of surface high-density electromyography (HD-EMG).

Real-time Neuromuscular Control of Exoskeletons

The purpose of this study is to develop a real-time controller for exoskeletons using neural information embedded in human musculature. This controller will consist of an online interface that anticipates human movement based on high-density electromyography (HD-EMG) recordings, and then translates it into functional assistance. This study will be carried out in both healthy participants and participants post-stroke. The researchers will develop an online algorithm (decoder) in currently existing exoskeletons that can extract hundreds of motor unit (MU) spiking activity out of HD-EMG recordings. The MU spiking activity is a train of action potentials coded by its timing of occurrence that gives access to a representative part of the neural code of human movement. The researchers will also develop a command encoder that can anticipate human intent (multi-joint position and force commands) from MU spiking activity to translate the neural information to movement. The researchers will integrate the decoder with the command encoder to showcase the real-time control of multiple joint lower-limb exoskeletons.

Influence of Brain Oscillation-Dependent TMS on Motor Function

Background: When people have a stroke, they often have difficulty moving their arms and hands. Transcranial magnetic stimulation (TMS) can improve how well people with and without stroke can move their arms and hands. But the effects of TMS are minor, and it doesn t work for everyone. Researchers want to study how to time brain stimulation so that the effects are more consistent. Objective: To understand how the brain responds to transcranial magnetic stimulation so that treatments for people with stroke can be improved. Eligibility: Adults ages 18 and older who had a stroke at least 6 months ago Healthy volunteers ages 50 and older Design: Participants will have up to 5 visits. At visit 1, participants will be screened with medical history and physical exam. Participants with stroke will also have TMS and surface electromyography (sEMG). For TMS, a brief electrical current will pass through a wire coil on the scalp. Participants may hear a click and feel a pull. Muscles may twitch. Participants may be asked to do simple movements during TMS. For sEMG, small electrodes will be attached to the skin and muscle activity will be recorded. At visit 2, participants will have magnetic resonance imaging (MRI). They will lie on a table that slides into a metal cylinder in a strong magnetic field. They will get earplugs for the loud noise. At visit 3, participants will have TMS, sEMG, and electroencephalography (EEG). For EEG, small electrodes on the scalp will record brainwaves. Participants will sit still, watch a movie, or do TMS. Participants may be asked to have 2 extra visits to redo procedures.

Human-like Robotic Controllers for Enhanced Motor Learning

The purpose of this study is to develop a new paradigm to understand how humans physically interact with each other at a single and at multiple joints, with multiple contact points, so as to synthesize robot controllers that can exhibit human-like behavior when interacting with humans (e.g., exoskeleton) or other co-robots. The investigators will develop models for a single joint robot (i.e. at the ankle joint) that can vary its haptic behavioral interactions at variable impedances, and replicate in a multi-joint robot (i.e. at the ankle, knee, and hip joints). The investigators will collect data from healthy participants and clinical populations to create a controller based on our models to implement in the robots. Then, the investigators will test our models via the robots to investigate the mechanisms underlying enhanced motor learning during different human-human haptic interaction behaviors (i.e. collaboration, competition, and cooperation. This study will be carried out in healthy participants, participants post-stroke, and participants with spinal cord injury (SCI).

Comparison of Anti-coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis

The primary goal of the trial is to determine if the experimental arms (rivaroxaban or ticagrelor or both) are superior to the clopidogrel arm for lowering the 1-year rate of ischemic stroke, intracerebral hemorrhage, or vascular death.

Mechanisms of Open and Hidden Placebo in Stroke Recovery

This trial aims to investigate whether placebo in isolation (open and hidden) has a specific neural signature in stroke subjects thus providing a novel mechanism to explain placebo effects that can be used to ultimately enhance stroke rehabilitation therapies.

Evaluation of Sensorimotor Ankle Impairments in Chronic Stroke

The purpose of this study is to capture sensorimotor ankle function in a chronic stroke population through validation of novel, experimental metrics and their comparison with established, clinical measures of function. For this purpose, the researchers will evaluate various single-joint, impairment-level measures such as visuomotor tracking performance and proprioception as well as functional-level measures including spatiotemporal gait (e.g., gait speed and stride length/time) and standardized clinical scales. This study will be carried out in chronic stroke patients as well as age-matched healthy controls. Results will help the researchers identify more quantitative metrics that can be used to monitor and rehabilitate sensorimotor function following stroke.

Effectiveness of Isokinetic Exercises in Proprioception for Post-stroke Patients

Somatosensory dysfunction including the sense of movement and position, i.e. proprioception, is observed in approximately 65% of patients after stroke. Loss of muscle strength, especially in the lower extremities, and impaired proprioception lead to significant loss of function in stroke patients. In addition, recent studies have emphasised that sensory information obtained by target-oriented exercises plays an important role in neuroplasticity and proprioception is an important element. The aim of this study was to evaluate the effect of knee isokinetic muscle strengthening exercises on proprioception and balance in stroke patients.

Relationship Between Clinical Status and Nerve Conduction Test Findings in Patients With Unilateral Hemiplegia

Stroke-related hemiplegia may be accompanied by peripheral nerve conduction abnormalities, which may contribute to motor impairment and functional limitations. However, the frequency of these abnormalities and their relationship with clinical status have not been fully characterized. This single-center observational study aims to evaluate the frequency of peripheral nerve conduction abnormalities identified by nerve conduction studies in patients with unilateral hemiplegia and to examine their association with motor and functional clinical assessment scores. The findings may contribute to a better understanding of peripheral nerve involvement in stroke rehabilitation.

SIMPLAAFY Clinical Trial

The primary objective is to demonstrate the safety and effectiveness of two monotherapy regimens versus dual antiplatelet (DAPT) therapy following post-implant with the WATCHMAN FLX Pro device in a commercial clinical setting.

Robotic-Assisted Training on Hand Function in Stroke

Stroke is a neurological deficit attributed to an acute focal injury of the central nervous system. A key component of stroke rehabilitation is improving upper limb function to reduce impairments and disabilities. A task-specific approach retraining for upper extremity control seeks to minimize impairments while maximizing the patient's functional performance. Technology-supported training is emerging to help therapists, patients, and the health system. Robotic devices allow to facilitate and control the complexity of a motor task. The benefits of robotic rehabilitation affect both therapists and patients: robot-assisted therapy can increase treatment compliance by way of introducing games or interactive upper limb tasks and patients can train independently with less supervision from therapists. Therefore, this study was conducted in line to determine the effect of robotic-assisted training on hand function in patients following a stroke.

Combining rTMS & Aerobic Exercise to Treat Depression and Improve Post-Stroke Walking

Investigators primary aim is to carry out a two-site, randomized, double-blind, sham-controlled, phase II trial to systematically examine the potential for aerobic exercise (AEx) to enhance the anti-depressant benefits of rTMS in individuals with post-stroke depression (PSD). Investigators propose to determine the efficacy of combining two known anti-depressant treatments shown to be effective in non-stroke depression, aerobic exercise (AEx) and repetitive transcranial magnetic stimulation (rTMS), on post-stroke depressive symptoms. This project is based on the idea that depression negatively affects the potential for the brain to adapt in response to treatment such that rehabilitation may not produce the same changes that it does in non-depressed individuals. Investigators believe that effective treatment for PSD will result in a virtuous cycle whereby reducing depression enhances response to rehabilitation, thereby facilitating functional gains. That is, effectively treating depression will enable individuals to better recover from stroke.

GaitBetter: Motor and Cognitive Training for Gait Rehabilitation and Falls Prevention in Stroke Survivors.

In this research study, the investigators aim to test the usability and efficacy of the GaitBetter system for gait rehabilitation after stroke.

At Home Wearable Sensors and Smartphone for Stroke Survivors With Upper Limb Motor Challenges.

The goal of this clinical trial is to learn if wearable sensor data visualization on smartphones can improve the use of the stroke-affected limb during everyday activities. Chronic stroke survivors (\>12 months from onset) ages 18-80 years old with residual upper extremity motor impairments may be eligible to participate. The main question it aims to answer is: Does the mobile health (mHealth) intervention help to improve the use of the stroke-affected upper-limb during daily living? The study is designed so each participant serves as their own control. Researchers will compare information from the baseline and intervention time periods to see if visualizing the data on the smartphone impacts the participant's daily use of the arm. Participants will be asked to wear a set of wearable ring and wrist sensors and interact with a custom-designed smartphone app, aiming to increase the use of their stroke-affected limb during daily activities as much as possible. They will receive feedback from the app, communicate with study therapists, participate in goal setting, complete clinical assessments, and share about their experience using the system during a virtual interview.