Clinical Research Directory

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.

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.

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.

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

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.

pBFS-guided iTBS Over the Left DLPFC for Chronic PSCI

The study aims to investigate the efficacy and safety of intermittent theta burst stimulation (iTBS) guided by the personalized Brain Functional Sector (pBFS) technique in the treatment of patients with chronic post-stroke cognitive impairment.

Functional Electrical Stimulation on Tibial Nerve in Stroke Patients.

Hemiparetic gait is one of the most common consequences after stroke. This impairment has a detrimental effects on the patients lies, limiting their social participation. Previous studies have shown that there is a direct relationship between triceps surae activation and gait speed in stroke patients, that is, higher triceps surae muscle activation are correspond to greater gait speed. Then, it can be hypothesized that therapies focused in strengthening the triceps surae also improves the patient gait. It has been shown that Functional Electrical Stimulation (FES) can improve triceps surae activation when applied on healthy subjects. However, it has not been yet explored in chronic stroke patients. Therefore, the aim of this study is to assess whether a FES program over tibial nerve contributes to the rehabilitation of the gait in chronic hemiparetic stroke patients. This study present a prospective interventional design, based on non-probabilistic sampling for convenience, and comprising a total of 15 volunteers with ischemic stroke of both genders and aged between 18 and 70 years old. Volunteers will be recruited from hospitals and private rehabilitation centres, and must be currently engaged in a conventional rehabilitation program. The study will consist of twenty-four sessions, with a frequency of three sessions per week.

The Effect of Action Observation Therapy Including Unimanual and Bimanual Activities in Chronic Stroke

Functional impairments in the upper extremities following a stroke significantly restrict individuals' activities of daily living and overall quality of life; in this context, Action Observation Training (AOT) has emerged in recent years as an effective rehabilitation method that promotes motor learning processes and cortical activity by activating the mirror neuron system. Although the literature acknowledges the positive effects on neural mechanisms of both unimanuel approaches, which focus on the paretic hand alone, and bimanual approaches, which involve the simultaneous use of both hands, there remains a gap regarding which method yields superior outcomes. This study aims to compare the effectiveness of AOT interventions consisting of exclusively unimanual versus exclusively bimanual activities on upper extremity functions, activities of daily living, and quality of life in chronic stroke patients, while investigating the potential differences between the outcomes of these two distinct approaches.

Effect of NMES on Balance and Fall Risk in Chronic Stroke

The aim of this study is to describe the effect of neuromuscular electrical stimulation (NMES) in the form of functional electrical stimulation (FES) applied to different lower limb muscles on reactive balance and gait performance in stroke participants. Methods: Twenty individuals with chronic stroke will be asked to perform an experimental protocol that includes a postural disturbance in the form of a slip- or trip-like perturbation and a standardized walking test in both laboratory and outdoor environments with and without FES applied to different lower limb muscles of the paretic leg. FES will be applied using an advanced software that is able to synchronize muscle activation with the time of perturbation onset and according to the phases of gait. This project design aims to examine whether a specific pattern of lower limb muscle stimulation could improve the kinematic and behavioral responses during reactive balance following slip- and trip-like perturbations. Additionally, the project aims to see if the kinematic and spatio-temporal gait parameters can be modified during a standardized walking test under different sensory and environmental conditions.

"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.

NOVEL Program for Stroke Telerehabilitation

Strokes are estimated to be the third most common cause of death in the world and the second most common cause of disability. Recently, the incidence of stroke has increased due to population aging. It is common for stroke survivors to experience a functional decline in their capacity to carry out daily activities as a consequence of their increasing dependence, which ultimately affects motivation levels, self-efficacy, and quality of life. Following a stroke, people often experience problems with upper limb function. Over half of people with upper limb impairments who have suffered a stroke continue to experience problems months or years afterward. A significant amount of rehabilitation is necessary to obtain meaningful recovery in the upper extremities and balance, but such interventions are difficult to access. As a cutting-edge method of neurorehabilitation, extended reality technology like virtual reality provides a more intensive simulation of functional activities than traditional physical therapy methods (aerobic, resistance, flexibility exercises, balance and coordination training, and functional exercises. The non-immersive type of VR can provide the patient with a safe experience so they can practice their exercises using gamification features integrated into the VR system, while remaining aware of their surroundings. According to the most recently published studies, there is promising evidence regarding the use of home-based exercises in stroke management especially after the Covid-19 pandemic. However, there is still a gap in identifying the evidence for using non-immersive home-based virtual reality exercises as telerehabilitation on the upper limb function and balance motor outcomes, adherence, and compliance with rehabilitation programs. In addition, no study have evaluated the validity and fidelity of the gamified features that can be added to the non-immersive VR exercises in terms of improving patient adherence and experience to their rehabilitation program. Moreover, the investigators still need rigorous qualitative studies to explore patient experiences after doing these exercises at home with remote monitoring from their rehabilitation team.

Outcomes and Health Economics of Stroke Using Rhythmic Auditory Stimulation

The purpose of this trial is to assess engagement, efficacy, durability, and impact on health care resource utilization of MR-001 in persons with chronic stroke who have a gait deficit after in-home/community use.

Safety and Efficacy of Hip Assist Powered Exoskeleton for Gait Training in Patients With Late Subacute and Chronic Stroke

The aim of this study is to evaluate the safety of gait training using a hip-assist powered exoskeleton. This will be assessed by collecting all device-related adverse events occurring during the entire intervention period, which consists of a total of 10 sessions within 5 weeks across two different gait rehabilitation protocols.

Exoskeleton Research: Myoelectric Orthosis for Rehab of Severe Chronic Arm Motor Deficits

This study will evaluate the effects of combining motor learning-based therapy with use of the MyoPro , a wearable exoskeletal myoelectrically controlled orthotic device. MyoPro uses electromyographic (EMG) signals from the weak muscles to assist movement of the user's affected arm. The primary objective of this randomized controlled trial is to study the efficacy of using MyoPro in motor learning-based therapy for individuals with chronic stroke (\>6 months post) with severe upper limb motor deficits (Fugl-Meyer for Upper Limb score less than 30) compared with a similar dose of motor learning-based therapy alone. The secondary objectives are to evaluate neuroplasticity mechanisms, identify biomarkers of greater response to the intervention, and explore cost-effectiveness.

Evaluation Of The Relationship Between The Conut Score And Balance And Functional Status In Patients With Chronic Stroke

The primary aim of this study is to evaluate the relationship between the CONUT score, which reflects nutritional status, and balance performance in patients with chronic stroke. The secondary aims are to investigate the association between the CONUT score and functional status and stroke-specific quality of life, as well as to assess the relationships of mid-upper arm circumference, an anthropometric indicator of nutritional status, and ultrasonographic rectus femoris muscle thickness, which reflects muscle mass, with balance performance, functional status, and stroke-specific quality of life. In addition, the study aims to examine the relationships between bone mineral density and balance, functional status, and ambulation level in patients with chronic stroke.

Comparison of EEG-Timed vs. Repetitive Robot Therapy for Chronic Stroke

This clinical trial compares two types of robotic hand rehabilitation-brain wave (EEG)-timed therapy versus simple repetitive therapy-to see which is more effective for recovering hand function in patients with chronic stroke. Participants will be randomly assigned to either group and will attend sessions using a wearable robotic hand device while wearing an EEG cap. In the EEG-timed group, the robot assists hand movements when participants successfully imagine moving and create specific brain signals, whereas in the repetitive group, the robot moves the hand automatically at set intervals. Both groups will receive a matched dose of robotic training to ensure a fair comparison of how the brain and hand function respond to the therapy.