Clinical Research Directory

Dynamic Stabilometry Combined With Transcranial Direct Current Stimulation for Balance and Motor Recovery After Ischemic Stroke

The goal of this clinical trial is to learn if balance training on a moving (dynamic) platform with visual and sound feedback, combined with weak electrical brain stimulation, helps people recover balance and movement after an ischemic stroke with weakness on one side of the body (hemiparesis). The main questions it aims to answer are: * Does the combination of dynamic platform training and active brain stimulation improve balance more than either method alone? * Does it improve independence in daily activities, mobility and walking, and reduce fall risk? * Is the combined treatment safe in the early period after stroke? Researchers will compare four groups: dynamic platform training with active stimulation, dynamic platform training with sham (imitation) stimulation, training on a locked (static) platform with active stimulation, and training on a locked platform with sham stimulation. Participants will: * Receive standard rehabilitation (exercise therapy and physiotherapy) of the same volume in all groups. * Complete 10 sessions of 20-minute platform training over 12 days (5 sessions per week), with active or sham brain stimulation during each session. * Have balance, mobility and neurological tests on Day 0, Day 6 and Day 12.

Stimulation Combined With Powered Motorized Orthoses for Walking After Stroke

Objective: The goal of this study is to implement and test a neuro-mechanical gait assist (NMGA) device to correct walking characterized by muscle weakness, incoordination or excessive tone in Veterans with hemiparesis after stroke that adversely affects their ability to walk, exercise, perform activities of daily living, and participate fully in personal, professional and social roles. Research Plan: A prototype NMGA device will be used to develop a finite state controller (FSC) to coordinate each user's volitional effort with surface muscle stimulation and motorized knee assistance as needed. Brace mounted sensors will be used to develop a gait event detector (GED) which will serve the FSC to advance through the phases of gait or stair climbing. In addition, a rule-base intent detection algorithm will be developed using brace mounted sensors and user interface input to select among various functions including walking, stairs climbing, sit-to-stand and stand-to-sit maneuvers. The FSC controller tuning and intent algorithm development and evaluation will be on pilot subjects with difficulty walking after stroke. Outcome measures during development will provide specifications for a new prototype NMGA design which will be evaluated on pilot subjects to test the hypothesis that the NMGA improves walking speed, distance and energy consumption of walking. These baseline data and device will be used to design a follow-up clinical trial to measure orthotic impact of NMGA on mobility in activities of daily living at home and community. Methodology: After meeting inclusion criteria, pilot subjects will undergo baseline gait evaluation with EMG activities of knee flexors and extensors, ankle plantar and dorsiflexors and isokinetic knee strength and passive resistance. They will be fitted with a NMGA combining a knee-ankle-foot-orthosis with a motorized knee joint and surface neuromuscular stimulation of plantar- and dorsi- flexors, vasti and rectus femoris. Brace mounted sensor data will be used for gait event detector (GED) algorithm development and evaluation. The GED will serve the FSC to proceed through phases of gait based on supervisory rule-based user intent recognition algorithm detected by brace mounted sensors and user input interface. The FSC will coordinate feed-forward control of tuned stimulation patterns and closed-loop controlled knee power assist as needed to control foot clearance during swing and stability of the knee during stance. Based on data attained during controller development and evaluation, a new prototype NMGA will be design, constructed and evaluated on pilot subjects to test the hypothesis that a NMGA device improves safety and stability, increases walking speed and distance and minimizes user effort. Clinical Significance: The anticipated outcome is improved gait stability with improved swing knee flexion, thus, increasing the safety and preventing injurious falls of ambulatory individuals with hemiplegia due to stroke found in large and ever-increasing numbers in the aging Veteran population. Correcting gait should lead to improved quality of life and participation.

Kinematic Analysis of Manual Dexterity

The following study aims to standardize the instrumented BBT for the objective evaluation of upper limb joint kinematics using MoCap on a population of healthy subjects between 4 and 18 years of age. After defining normative data characteristic of the gesture, the study aims to characterize the pathological upper limb movement in pediatric subjects with pyramidal hemisyndrome (cerebral palsy, arteriovenous malformation, brain tumors and head trauma) and Down Syndrome, comparing the data obtained with the normative data.

Implementing Outcome Measures in Stroke Rehabilitation

The primary objective of this study is to tailor and test implementation strategies to support the adoption of two upper extremity motor outcome measures for stroke: the Fugl-Meyer Assessment and the Action Research Arm Test. The study's interdisciplinary team will address this objective through the following specific aims: (a) Tailor a package of implementation strategies (referred to as I-STROM-Implementation STRategies for Outcome Measurement) to promote outcome measure use across the care continuum, (b) Determine the effectiveness of I-STROM on outcome measure adoption and (c) Evaluate the appropriateness, acceptability, and feasibility of I-STROM in rehabilitation settings across the country. The mixed-methods study design is informed by implementation science methodologies, and the tailoring of I-STROM will be guided by input from stakeholders, including occupational therapy practitioners and administrators. The investigators will collect robust quantitative and qualitative data by means of retrospective chart reviews, electronic surveys, and stakeholder focus groups. This study, "Strategies to Promote the Implementation of Outcome Measures in Stroke Rehabilitation," will address core barriers to outcome measure use through a package of implementation strategies, thus laying the groundwork for I-STROM scale-up in health systems nationwide.

Evaluation of the Safety and Performance of the AWAKE Device in Patients With Hemiplegia or Hemiparesis Secondary to Stroke (ACV).

Stroke is a leading cause of disability in adults, with gait impairment being a key functional limitation. Although lower limb exoskeletons are used in rehabilitation, the available evidence focuses on bilateral devices used in clinical settings with continuous supervision by healthcare professionals, and is limited for solutions with alternative configurations and usage conditions. The AWAKE device is designed as a compensatory solution for gait impairment following stroke. It features a unilateral configuration, low weight, and a design intended for use with a companion (not necessarily a medical professional) in broader settings. The purpose of this study is to demonstrate that the AWAKE device is safe and functions properly for its intended use in patients with hemiplegia or hemiparesis secondary to a stroke, together with a companion, provided that both have successfully completed the planned training and education program. This is a prospective, multicenter, single-arm, open-label, interventional clinical study designed to evaluate the safety and performance of the AWAKE device in patients with hemiplegia or hemiparesis secondary to stroke, along with their usual companion. The total number of patients will be: Twenty pairs (patient + regular companion) will be recruited and equally divided between two participating centers. Each pair will undergo 10 to 20 sessions, two or three times per week, under the supervision of healthcare professionals previously trained by the manufacturer.

Trans Auricular Vagus Nerve Stimulation (taVNS) and Robotic Training for Paralyzed Arm After Stroke

To determine whether treatment with transauricular vagus nerve stimulation (taVNS) during the training of an affected upper limb of a patient with chronic stroke on a robotic motor task alters the motor impairment.

Quadriceps Muscle Activity and Gait Kinematics in Patients With Post-Stroke Stiff-Knee Gait Compared With Healthy Controls

Stiff-knee gait (SKG) is a frequent gait abnormality in people with post-stroke hemiparesis and is characterized by insufficient knee flexion during the swing phase of walking. One potential mechanism is inappropriate activation of one or more heads of the quadriceps during pre-swing and early swing. This observational study will compare quadriceps electromyographic activity and gait kinematics between adults with chronic post-stroke hemiparesis with SKG and healthy adult controls. The study will include 30 participants with post-stroke SKG and 24 healthy controls. Quantitative gait analysis will be performed using three-dimensional motion analysis together with electromyography (EMG). Ultrasound-guided fine-wire electrodes will record the activity of all four heads of the quadriceps: rectus femoris, vastus intermedius, vastus medialis, and vastus lateralis. Healthy controls will be assessed while walking at a slow speed selected to provide a reference condition that is comparable with the walking speeds typically observed in participants with post-stroke hemiparesis. The primary outcome is the difference in fine-wire EMG activation patterns of the four quadriceps heads between participants with post-stroke SKG and healthy controls, with particular attention to pre-swing and early swing. Secondary outcomes will assess differences in gait kinematics between groups, including peak knee flexion during the swing phase and knee flexion-extension patterns throughout the gait cycle. The study aims to improve understanding of the muscular mechanisms underlying post-stroke SKG and to establish relevant fine-wire EMG reference patterns for all four quadriceps heads in healthy individuals walking at a speed comparable with patients with hemiparesis.

Evaluation of the Effectiveness and Safety of Keeogo™ Dermoskeleton in Subjects With Mobility Impairments Due to Stroke

A multi-site, interventional, non-comparative, single-arm trial to evaluate the safety of the Keeogo™ Dermoskeleton in subjects with hemiparesis due to ischemic or hemorrhagic stroke.

Vibrotactile Feedback to Improve Walking After Stroke

Stroke survivors often walk more slowly and may have difficulty producing the movements needed to walk efficiently. This study will evaluate whether vibrotactile feedback, delivered through small wearable devices that provide vibrations during walking, can help individuals with chronic stroke change specific walking movements related to walking speed, propulsion, and balance. Participants will complete a single study visit at Bucknell University. During the visit, participants will perform several walking trials with and without vibrotactile feedback and will complete common clinical mobility and balance assessments. Motion capture technology and wearable sensors will be used to measure movement during walking. The goal of this study is to better understand how vibrotactile feedback can be used to improve walking performance after stroke and to support the future development of rehabilitation approaches for stroke survivors.

Dance Workshop on Balance of Hemiparetic Patients

The majority of hemiparetic patients have balance disorders, which impact independence in daily living activities and walking. Conventional techniques used in rehabilitation improve balance but have shown no effects on dynamic balance required during walking. Recently dance is proposed to improve dynamic balance in older people and people with Parkinson's disease. Although many studies showed that dance is an effective activity to improve balance in these people, it has never been assessed in hemiparetic patients (except a case report). The aim of this study is to show that a dance program improves the balance of hemiparetic patients, compared to a control group. This randomized controlled study aims to include 40 hemiparetic patients who will perform a dance program (experimental group) or a upper-limb rehabilitation program (control group) for 8 one-hour sessions.

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.

Motor Imagery Added to Robot-Assisted Hand Rehabilitation After Stroke

Loss of upper extremity and particularly hand function after stroke reduces independence in daily activities such as eating, dressing, and personal care. Robot-assisted hand rehabilitation provides repetitive, intensive, and task-oriented practice that supports motor learning, dexterity, and functional hand use. Motor imagery, the mental rehearsal of a movement without physically performing it, is thought to activate motor-related brain networks and to support motor learning and neuroplasticity. Evidence on the added value of combining motor imagery with robot-assisted hand rehabilitation for activities of daily living is limited. This randomized controlled trial will investigate whether motor imagery training added to robot-assisted hand rehabilitation produces greater improvement in activities of daily living than robot-assisted hand rehabilitation alone in individuals with stroke. Forty participants will be randomly allocated to an experimental group (robot-assisted hand rehabilitation plus motor imagery, n=20) or a control group (robot-assisted hand rehabilitation alone, n=20). Both groups will receive the same dose of robot-assisted hand rehabilitation with a soft robotic hand rehabilitation glove, three days per week for six weeks. Outcomes will be assessed at baseline and after the six-week program.

rTMS Plus CCFES-mediated Functional Task Practice for Severe Stroke

This study is a necessary and important step in the development of a new therapy for upper limb functional recovery in patients with severe motor impairment. It is the first clinical trial of non-invasive brain stimulation (repetitive transcranial magnetic stimulation or rTMS) delivered to excite the undamaged hemisphere (specifically the contralesional higher motor cortices or cHMC) in stroke. Therefore, this study will determine whether the positive results obtained in our short-term pilot study can be made to last longer and produce functional benefits in severe patients with the application of brain stimulation in combination with long-term rehabilitation therapy. Rehabilitation therapy administered is called contralaterally controlled functional electrical stimulation (CCFES). Determining whether combining rTMS facilitating the cHMC with CCFES produces synergistic gains in functional abilities in severe patients is necessary for acceptance by the clinical community and to move this technology toward commercialization and widespread dissemination. The proposed study will determine whether the combination of rTMS facilitating the cHMC with CCFES produces greater improvements in upper extremity function in severe participants who are ≥6 months from stroke onset than the combination of rTMS facilitating the damaged hemisphere (specifically the ipsilesional primary motor cortex, iM1) and CCFES or the combination of sham rTMS and CCFES. The secondary purposes are to define which patients benefit most from the treatments, which may inform future device and treatment development and clinical translation, and to explore what distinct effects the three treatments have on the brain. To accomplish these purposes, we are conducting a clinical trial that enrolls severe stroke patients.

Robotic Exoskeleton Gait Training With and Without Brain-Computer Interface Control After Stroke

After a stroke, many people have trouble walking. One way to practice walking again is with a wearable robot, called an exoskeleton, that supports the legs and guides them through a walking pattern. In most systems, a therapist or a sensor decides when each step starts. This study looked at whether it helps to let a person's own brain activity start each step instead. Sensors placed on the scalp recorded brain signals. A computer read these signals and told the robot when to take a step. This way of controlling a device is called a brain-computer interface. People who had a stroke within the past year took part. They were placed by chance into one of two groups. One group practiced walking with the robot in the usual way. The other group practiced with the robot controlled by their own brain signals. Both groups trained twice a week for 4 weeks. Before and after the training, the study team measured how far each person could walk in 6 minutes, how long it took to stand up and walk a short distance and sit down again, how strong the knee muscles were, and how each person rated their own health and well-being. The study compared how much the two groups improved.

Fully Remote Use of IpsiHand Device in Hemiparetic Stroke

BCI-REHAB was a randomized clinical trial comparing an at-home brain-computer interface therapy system versus an at-home exercise program for upper-extremity rehabilitation in the chronic phases of stroke. The purpose of the trial was to evaluate the efficacy of BCI-based therapy tested against standard exercise therapy and assess the potential for meaningful motor improvement in the home environment.

Effect of Mental Arithmetic Priming on Gait and Balance in Stroke

This study investigates the effect of cognitive priming through mental arithmetic on functional mobility in post-stroke patients. It hypothesizes that performing mental calculations (addition, subtraction, multiplication) prior to movement stimulates frontoparietal networks, thereby improving gait speed and dynamic balance compared to a passive control condition.

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.

Neuroplasticity After Proprioceptive Rehabiliation

Sequences of muscle tendon vibrations allow to reproduce the sensory feedback during movement like locomotion and kinaesthesia. It is known that such a treatment promotes motor recovery after stroke assuming that it enhances neuroplasticity. The aim of the research is to study the activity in cerebrospinal circuitry to evaluate the neuroplastic changes during and after instrumented proprioceptive rehabilitation relying on sequences of muscle vibration in subacute stroke stages.

Repetitive Transcranial Magnetic Stimulation in Cardiac Autonomic Dysfunction

The aim of this study is to investigate the effects of repetitive transcranial magnetic stimulation (rTMS) added to conventional neurological rehabilitation on heart rate variability (HRV), quality of life, upper extremity muscle strength and autonomic symptoms in patients with stroke.

Efficacy of Tele-CPASS Compared to In-person CPASS Therapy for Upper Extremity Motor Recovery

This study evaluates whether a home-based telerehabilitation program (tele-CPASS) is as effective as an in-person rehabilitation program (CPASS) for improving arm and hand function after stroke. Stroke often leads to long-term difficulty using the affected arm in daily activities, and access to in-person therapy can be limited. This study aims to determine whether therapy delivered remotely can provide similar benefits to standard in-clinic care. Participants who recently experienced a stroke will be randomly assigned to receive 20 hours of upper extremity rehabilitation therapy either in person or through a telehealth platform. Both groups will receive the same type and amount of therapy focused on practicing meaningful, patient-selected daily activities. Participants will complete assessments before treatment, immediately after treatment, and at 6 and 12 months to measure recovery of arm function, real-world arm use, and participation in daily life. The results of this study will help determine whether telerehabilitation can improve access to effective stroke recovery interventions while maintaining clinical effectiveness comparable to in-person therapy.

Effect of Task Oriented Training With Functional Electrical Stimulation on Balance in Children With Hemiparesis

To investigate the efficacy of combination of task-oriented training and Functional electrical stimulation of ankle dorsiflexor muscles on: 1. Strength of ankle muscles in children with hemiparesis. 2. Balance in children with hemiparesis.

Perinatal Arterial Stroke: A Multi-site RCT of Intensive Infant Rehabilitation (I-ACQUIRE)

This is a Phase III clinical trial to compare the efficacy of two dosages of a new infant rehabilitation protocol - I-ACQUIRE - to usual and customary forms of infant rehabilitation in infants who experienced Perinatal Arterial Stroke (PAS).

the Effect of the CALIGALOC Orthosis on Standing and Walking of Hemiparetic Patients With Ankle Varus

To assess the benefit of an anti-varus ankle foot orthosis (CALIGALOC, Bauerfeind) on gait and balance parameters in hemiparetic patients.

rTMS Posterior Parietal Cortex Modulation and Upper Limb Movement After Stroke

This study evaluates the effect of a unique session of inhibitory rTMS (cTBS) over the contralesional posterio parietal cortex (PPC) on the spatio-temporal parameters of a pointing movement performed by stroke patients with their paretic upper limb. It will also assess the effects on the resting motor threshold of both hemispheres and on parietopremotor connectivity. To achieve theses aims, the real cTBS stimulation will be randomly counterbalanced with a SHAM stimulation (in a second session) in a crossover design. Assessments will be performed before and after each stimulation session.