Clinical Research Directory

Effects of Transcutaneous Electrical Nerve Stimulation on Cognitive Function and Upper Limb Motor Function in People With Chronic Stroke

Upper limb impairment is present in more than 85% of people with stroke, which greatly affect the quality of life, social participation, and performance of daily activities of people with stroke. Previous study also revealed that 53.4% of people after stroke experienced cognitive impairment. Different cognitive domains might be affected following stroke, such as attention, memory, language, and orientation, and the problems with memory are often prominent. Yet, there is no effective treatment for the post-stroke cognitive impairment. Transcutaneous spinal cord stimulation (tSCS) and transcutaneous vagus nerve stimulation (tVNS) are simple and non-invasive treatment to improve upper limb motor function and cognitive function. However, no existing studies have explored on the effects of tSCS and tVNS on cognitive function in people with stroke. Therefore, the purpose of this study is to evaluate the effectiveness of transcutaneous electrical nerve stimulation (TENS) on improving upper limb function and cognitive function in people with chronic stroke.

Psychometric Study of the Spanish Version of Two Upper Limb Assessment Scales in Chronic Stroke

The purpose of this cross-sectional study is to translate and cross-culturally adapt to Spanish the Motor Evaluation Scale for Upper Extremity in Stroke Patients (MESUPES) and the Stroke Upper Limb Capacity Scale (SULCS) and to assess their psychometric properties in Spanish people with chronic stroke.

Transcranial Direct Current Stimulation Enhances Dual-task Performance in Stroke

Stroke often impairs lower limb control, resulting in gait abnormalities and difficulties in dual-task performance, such as walking while engaging in cognitive activities. This study examines the effects of a single session of transcranial direct current stimulation (tDCS) targeting the left dorsolateral prefrontal cortex (DLPFC) on dual-task walking performance in individuals with chronic stroke. Using a cross-over design, participants will undergo two sessions (active or sham tDCS, 7 ± 2 days apart) of stimulation at 2 mA for 30 minutes. Walking performance will be measured using single and dual-task conditions combining motor (e.g., 20 m walk) and cognitive tasks (e.g., word association, random number recall). Primary outcomes include walking speed (m/s), stride length (m), and dual-task cost (DTC) for mobility and cognitive speed. The study aims to evaluate tDCS as a potential tool to reduce DTC, improve dual-task performance, and improve daily function and quality of life in stroke survivors. Results may guide the development of tailored dual-task interventions in stroke rehabilitation.

Post-Stroke Walking Speed and Community Ambulation Conversion Study

The purpose of this randomized, controlled study is to collect performance data on the ability of an investigational device designed to digitally deliver Rhythmic Auditory Stimulation to improve walking speed in people who suffered a stroke greater than or equal to six (6) months in the past and who are limited in mobility outside the home. The primary outcomes will be the mean change in walking speed (meters per second) and mean percent change in walking speed as determined by a 10-meter Walk Test after five weeks of intervention and compared between groups.

Actimetry Monitoring of the Paretic Upper Limb in Chronic Post Stroke.

After a stroke, 80% of patients continue to have difficulty using their paretic upper limb in activities of daily living (ADL) despite post-stroke rehabilitation practices that aim to promote the use of the paretic upper limb. It is known that functional recovery depends on actual use (Use it or Loose it), but one-time measurements in the clinic do not allow quantification of the actual use of the paretic upper limb in daily life (in the person's living environment). The investigators hypothesize the feasibility of quantifying functional use of the paretic upper limb by actimetry in clinical routine.

The Effect of Local Vibration Therapy Combined With a Structured Exercise Program on Functional Status in Individuals With Chronic Stroke

The goal of this clinical trial is to learn if adding neck vibration to structured exercises improves balance and movement in adults with long-term stroke. The main questions it aims to answer are: Does this exercise and vibration program improve balance, walking, and daily living skills? Is structured exercise with neck vibration more effective than traditional exercise with neck vibration? Researchers will compare a structured exercise group to a traditional exercise group to see if one works better. Participants will: Complete exercise sessions 2 days a week for 12 weeks Receive 5 minutes of mild neck vibration after each exercise session Take balance, walking, and daily activity tests at the start and end of the study

Brain Stimulation for Improving Cognition in Chronic Stroke (NEPTUNE)

Few treatments are available for post-stroke rehabilitation. The current study aims to develop a novel, short-term, high-dose repetitive transcranial magnetic stimulation (rTMS) based intervention to improve post-stroke cognitive problems. This study will test the safety as well as changes in cognitive function and brain activation with the administration of an accelerated rTMS protocol in chronic stroke.

Virtual Physical Activity Seated Exercise - Phase 2

This study will determine the acceptability of delivering seated exercises online and if seated exercises can improve balance, mobility, quality of life, and cardiometabolic health in those living with a stroke related mobility impairment. Participants will be allocated to either a 10-week seated exercise program or a delayed 2-week Boot Camp program. All seated exercises sessions and assessments will be conducted virtually.

Personalized Transcranial Direct Current Stimulation in Stroke Recovery

The central objective of this application is to explore the neural substrate of personalized tDCS (ptDCS) and to determine whether the paradigm for each stroke patient can predict the amount of sustained clinical improvement through increased connectivity as measured by a biomarker of plasticity.

"Effects of a Combined Repetitive Transcranial Magnetic Stimulation and Physical Therapy Protocol on Motor Function, Balance, and Quality of Life in Chronic Post-Stroke Hemiplegia: A Case Series"

Chronic post-stroke hemiplegia frequently results in persistent motor deficits, impaired balance, and reduced quality of life. Conventional physical therapy is fundamental for functional recovery; however, motor improvement often plateaus during the chronic phase. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technique that has shown potential to enhance motor recovery by modulating cortical excitability and promoting neuroplasticity. This case series aims to investigate the effects of a combined protocol of repetitive transcranial magnetic stimulation and conventional physical therapy on motor function, balance, and quality of life in individuals with chronic post-stroke hemiplegia. Participants will undergo rTMS applied to the motor cortex in conjunction with a structured physical therapy program. Clinical outcomes will be assessed before and after the intervention to explore feasibility, safety, and potential functional benefits of the combined approach.

Ankle Robotics for Error Augmentation After Stroke

The goal of this pilot clinical trial is to test whether training with a portable ankle robot improves ankle push-off and walking speed in adults with chronic stroke who have ankle weakness. The study will also evaluate whether the device is safe and practical to use during walking rehabilitation. The main questions it aims to answer are: Does training with the portable ankle robot improve paretic ankle propulsion during walking? Does training with the portable ankle robot improve walking speed at self-selected and fast walking speeds? Participants will: Complete 30 training sessions of treadmill and overground walking while wearing the portable ankle robot, 3 to 4 times per week over 8 to 9 weeks Complete walking and movement assessments before training, after 15 sessions, and after 30 sessions Walk at self-selected and fast speeds while researchers measure ankle propulsion, gait symmetry, and walking speed

Reflex Excitability in Post-stroke Stiff-Knee Gait

The purpose of this study is to examine the reflex excitability of the rectus femoris in individuals with and without post-stroke Stiff-Knee gait. We use electrical stimulation of the peripheral nerve innervating the rectus femoris for a well-controlled reflex stimulus. We are investigating whether reflex excitability of the rectus femoris correlates with gait kinematics.

RGS@Home: Personalized 24/7 Home Care Post-stroke

Stroke represents one of the main causes of adult disability and will be one of the main contributors to the burden of disease in 2030. However, the healthcare systems are not able to respond to the current demand let alone its future increase. There is a need to deploy new approaches that advance current rehabilitation methods and enhance their efficiency. One of the latest approaches used for the rehabilitation of a wide range of deficits of the nervous system is based on virtual reality (VR) applications, which combine training scenarios with dedicated interface devices such as the Rehabilitation Gaming System (RGS), a science-based ICT solution for neurorehabilitation combining brain theory, AI, cloud computing and virtual reality and targeting motor and cognitive recovery after stroke. RGS provides a continuum of evaluations and therapeutic solutions that accompany the patient from the clinic to the therapy centre. RGS has been clinically validated. However, in order to achieve significant benefits in the patients' QoL, it is essential that this technological solution becomes an at home solution providing training and 24/7 monitoring and care. For this reason, this project aims at investigating not only its clinical validity but also the RGS acceptability and adoption model. The findings derived from this study will contribute to establish a novel neurorehabilitation paradigm that can accelerate the recovery of hemiparetic stroke patients. Besides the clinical impact, such achievement could have relevant socioeconomic impact.

Distal Versus Proximal Balance Training in Chronic Stroke

Study will include two different intervention groups. Both groups will receive a standardized 50-minute multimodal rehabilitation program consisting of 30 minutes of Bobath-based exercises, 10 minutes of neuromuscular electrical stimulation (NMES) applied to the hemiparetic limb, and 10 minutes of bicycle ergometer training. In addition, both groups will receive 15 minutes of technology-assisted balance training, 5 days per week for 4 weeks. Group 1 will receive distal (ankle-strategy) balance training (DBT) using the Technobody Prokin system, including interactive "Game Pong" tasks with controlled anteroposterior and mediolateral platform displacement. Group 2 will receive proximal (hip-strategy) balance training (PBT) using the TheraTrainer Balo device. Study Aim: To investigate and compare the effects of technology-assisted distal (ankle-strategy) versus proximal (hip-strategy) balance training, each added to a standardized multimodal rehabilitation program, on balance, posture and functional outcomes in individuals with chronic stroke.

Blood Flow Restriction and Transcutaneous Electrical Nerve Stimulation on Motor Function in Stroke

Stroke commonly results in persistent leg impairments that limit mobility and reduce quality of life. This study investigates whether combining low-intensity resistance training with blood flow restriction (LIRT-BFR) and transcutaneous electrical nerve stimulation (TENS) can effectively improve leg function in stroke survivors. Participants with chronic stroke will be randomly assigned to one of four intervention groups: 1) LIRT with simulated BFR and simulated TENS; 2) LIRT with actual BFR and simulated TENS; 3) LIRT with simulated BFR and actual TENS; 4) LIRT with both actual BFR and actual TENS. The resistance training utilizes 20% of each participant's maximum lifting capacity. For blood flow restriction, an automated pressure cuff (SmartCuffs 4.0) will be placed on the upper portion of the affected leg, inflated to 50% of the individual's occlusion pressure during exercises and deflated during rest periods. TENS therapy delivers controlled electrical impulses through electrodes positioned on the anterior thigh. Each 60-minute session includes a 10-minute warm-up followed by 40 minutes of targeted resistance exercises (leg extensions, leg presses, and weight-bearing squats) and concludes with 10 minutes of stationary cycling. The resistance protocol involves 3 sets of 20 repetitions with standardized rest intervals between sets and exercises. Participants will attend three sessions weekly for six weeks. Assessments will be conducted at baseline, midpoint (3 weeks), completion (6 weeks), and follow-up (1 month post-intervention). The primary outcome measure is the Fugl-Meyer Assessment for Lower Extremity function, with secondary measures including muscle strength, stiffness, balance, mobility, walking capacity, and gait parameters. To understand the underlying mechanisms, we will measure muscle oxygenation using near-infrared spectroscopy, evaluate muscle structure via ultrasound, and monitor physiological responses including heart rate variability and perceived exertion for safety monitoring.

Hand Rehabilitation Study for Stroke Patients

The purpose of this study is to find out what are the best settings for applying electrical nerve stimulation over the skin for the short-term improvement of hand dysfunction after a stroke. The ultimate goal is to some day design an effective long-term training program to help someone recovery their ability to use their hands and function independently at home and in society. In order to know how to apply electrical nerve stimulation to produce a good long-term effect on hand dysfunction, the investigators first need to know how to make it work best in the short-term, and improve our understanding of for whom it works and how it works. The investigators will use a commercially available transcutaneous electrical nerve stimulation (TENS) unit to gently apply electrical nerve stimulation over the skin of the affected arm. This is a portable, safe and easy to use device designed for patients to operate in their homes.

Plantar Sensation, Position Sense, and Weight-Bearing Asymmetry Related to Balance and Mobility Post-Stroke

This study aims to examine how sensory deficits and weight-bearing asymmetry affect posture, balance, and mobility in individuals with chronic stroke. The research focuses on evaluating the relationships between plantar foot sensation, lower extremity position sense, and asymmetrical weight distribution with functional abilities such as walking and postural control. Participants will undergo non-invasive assessments, including sensation tests, mobility and balance evaluations, and postural measurements. A total of 24 individuals with chronic stroke who are receiving physiotherapy at a rehabilitation center in Konya, Türkiye, will be included. The results of this observational, cross-sectional study may contribute to a better understanding of the sensory-motor interactions in stroke survivors and support the development of more targeted rehabilitation strategies.

Task-Oriented Training Versus High-Intensity Gait Training in People With Chronic Stroke

The purpose of this study is to compare the effects of high-repetition task-oriented training and high-intensity gait training on walking capacity and functional mobility in individuals with chronic stroke. Forty-five participants will be randomly assigned to one of three groups: (1) neurodevelopmental treatment (NDT) alone, (2) NDT combined with high-repetition task-oriented training, or (3) NDT combined with high-intensity gait training. All participants will receive treatment 3 days per week for 8 weeks (24 sessions in total). Walking capacity (6-Minute Walk Test) and functional mobility (Timed Up and Go Test, modified Dynamic Gait Index, 10-Meter Walk Test) will be assessed before and after the intervention by an assessor blinded to group allocation. The study hypothesizes that adding structured, intensity-based training approaches to conventional NDT will lead to greater improvements in walking capacity than NDT alone.

Home-based FES Training in People With Chronic Stroke

This project will examine the feasibility, safety and effect of home-based functional electrical stimulation (FES) applied to different lower limb muscles in combination with task-specific training on gait, balance and mobility in adults with chronic stroke. 30 individuals with chronic stroke will first undergo initial screening and baseline walking, mobility, balance and strength assessments in the laboratory. After determining their eligibility for the study, they will undergo 12-weeks of home-based FES and task-specific training. Following the initial screening (week 1) and pre-intervention assessment (week 2), participants will be trained in the lab for 6 sessions (week 3-4) for a FES home program and then given a FES home kit (FES device and an android tablet). Participants will then undergo home-training for 2 weeks (week 5-6) followed by mid-training assessment (week 7). Again, participants will undergo 4-weeks of home training (week 8-11) and final assessment at the end of training (week 12). This project has the following specific aims: Aim 1: To investigate the feasibility, safety and efficacy of 12-weeks of home-based FES and task-specific training in adults with chronic stroke. Aim 2: To examine the effect of 12-weeks of home-based FES and task-specific training on mobility, gait and balance (anticipatory and reactive balance) in adults with chronic stroke.

Spinal Cord Stimulation Combined With Motor Imagery Brain-Computer Interface for Chronic Post-Stroke Upper Limb Motor Dysfunction

This clinical study aims to evaluate the efficacy and safety of spinal cord stimulation combined with non-invasive motor imagery brain-computer interface rehabilitation training in patients with upper limb motor dysfunction after chronic stroke. The study includes an experimental group receiving spinal cord stimulation combined with motor imagery brain-computer interface rehabilitation training and a control group receiving motor imagery brain-computer interface rehabilitation training alone. The primary outcome is upper limb motor function assessed by the Fugl-Meyer Assessment for Upper Extremity. Secondary outcomes include muscle tone, upper limb functional activity, activities of daily living, adverse events, serious adverse events, and exploratory neurophysiological and neuroimaging indicators.

Feasibility and Efficacy of PRO-MAMAS

This experimental design will assess the feasibility \& initial effectiveness of PRO-MAMAS (promoting participation, health and wellbeing through meaningful maternal-role activities after stroke and other chronic conditions) - a novel occupational therapy intervention program to promote participation, health and wellbeing of older mothers with chronic stroke. Assessments will be conducted at three time points: baseline, pre, post the Pro-MAMA intervention

Effects of Different Doses of Virtual Reality Therapy in Chronic Stroke Patients

This study aimed to compare the effects of different doses of Wii Fit-based virtual reality (VR) therapy added to conventional rehabilitation in patients with chronic stroke. Forty-three patients were randomly assigned to three groups: a control group receiving conventional rehabilitation only (5 days/week, 45 min/session for 4 weeks), a VR3 group receiving conventional rehabilitation plus VR training three days per week (20 min/session, 12 sessions total), and a VR5 group receiving conventional rehabilitation plus VR training five days per week (20 min/session, 20 sessions total). Balance (Berg Balance Scale), functional independence (Functional Independence Measure), stroke-specific quality of life (SS-QOL), static postural alignment (Becure Posture Mobile), and center of pressure measurements (Becure Balance System) were assessed before treatment (T0), after treatment (T1), and at one-month follow-up (T2). This prospective, single-blind, randomized controlled trial was conducted at Istanbul Physical Medicine Rehabilitation Training and Research Hospital.

Wireless Nerve Stimulation Device To Enhance Recovery After Stroke

Texas Biomedical Device Center (TxBDC) has developed an innovative strategy to enhance recovery of motor and sensory function after neurological injury termed targeted plasticity therapy (TPT). This technique uses brief pulses of vagus nerve stimulation to engage pro-plasticity neuromodulatory circuits during rehabilitation exercises. Preclinical findings demonstrate that VNS paired with rehabilitative training enhances recovery in multiple models of neurological injury, including stroke, spinal cord injury, intracerebral hemorrhage, and traumatic brain injury. Recovery is associated with neural plasticity in spared motor networks in the brain and spinal cord. Moreover, two initial studies and a recently completed Phase 3 clinical trial using a commercially available device demonstrates that paired VNS with rehabilitation is safe and improves motor recovery after stroke. The purpose of this study is to extend these findings and evaluate whether VNS delivered with the new device paired with rehabilitation represents a safe and feasible strategy to improve recovery of motor and sensory function in participants with stroke.

Paired Vagus Nerve Stimulation Mechanisms

In this mechanistic study, 40 individuals with chronic stroke will be implanted with a small vagus nerve stimulation (VNS) device. The study will use a randomized, blinded, crossover design to deliver two conditions in six-week blocks: active VNS or sham VNS, each paired with upper extremity (UE) motor rehabilitation. Assessment visits will occur before and after each block, and will examine neural pathway strength, functional connectivity, and motor and non-motor behaviors. Investigators will test for VNS-induced changes in motor, cognitive, and affective systems, and will identify biomarkers predictive of clinical response.