Hemiplegia

Researchers are studying patients who have had an acute ischemic stroke affecting the basal ganglia and were treated with mechanical thrombectomy. The study aims to understand how often and in what ways cognitive, motor, and sleep problems occur after this treatment. The main focus is on defining these possible dysfunctions in the short and long term after stroke treatment. The study involves patients who have undergone mechanical thrombectomy for stroke in the proximal middle cerebral artery. Participants will be evaluated using tests for cognitive function, movement abilities, and sleep disorders. Specifically, sleep will be studied through polysomnographic examinations. Assessments occur in the acute phase soon after treatment and continue through long-term follow-up. Participants will undergo testing for cognitive, motor, and sleep function within 72 hours after their stroke treatment and at later points to monitor changes over time. The primary outcome is the presence of post-stroke cognitive dysfunction measured shortly after treatment. The research team will closely observe clinical outcomes related to movement and sleep as well. The study is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS and involves adult participants starting from age 18.

Researchers are studying the brain's action observation network (AON), which is involved in understanding and imitating movements, especially focusing on subcortical areas and the cerebellum. The study aims to explore how this network functions in healthy individuals and in people with Cerebral Palsy (CP) who have early brain injuries. This research seeks to understand differences in brain activation patterns and their relation to clinical features in CP patients using advanced imaging techniques. Participants will undergo a 7 Tesla MRI scan using a high-resolution functional and anatomical protocol. The MRI will capture detailed images of brain structures including the cerebral cortex, subcortical nuclei, and cerebellum. Visual tasks involving observation of hand movements and tool use will be presented during the scan. CP patients will also receive a full clinical assessment before the MRI. The study includes both healthy volunteers and CP patients, with careful monitoring of participant compliance to avoid motion artifacts. During the study, researchers will evaluate brain activation and connectivity maps of the AON from the 7T MRI data. Participants' motor functions and clinical characteristics will be assessed for correlation with imaging results. The study involves observation during MRI scanning, clinical assessments, and monitoring of participants' responses to visual stimuli. This trial is expected to provide detailed insights into brain network organization and its changes in CP. The total participation includes MRI scanning and clinical evaluations around a single visit.

Researchers are evaluating the effect of involving caregivers in a rehabilitation approach called caregiver-assisted rehabilitation with strategy training (CAR-ST) to improve daily activity functions in adults who have had a stroke. The study aims to compare CAR-ST with strategy training alone and with an education program to see which approach leads to better improvements in activity performance and whether these improvements extend to other areas like participation and impairment. This is a single-blinded, three-arm randomized controlled trial conducted in multiple centers to assess the potential benefits of caregiver involvement in home-based post-stroke rehabilitation. Participants will be randomly assigned to one of three groups: CAR-ST, strategy training alone, or an education program. The CAR-ST and strategy training groups receive up to 10 therapist-guided sessions over a maximum of 6 weeks, with sessions once or twice weekly lasting about 60 minutes each. CAR-ST involves caregivers actively assisting and motivating participants during at-home practice, while the strategy training group does not include caregiver participation. The education group receives 10 matched sessions focused on stroke information delivered through face-to-face talks, video calls, or phone calls. During the study, participants will be assessed at four time points: before treatment, immediately after the intervention, and at 3- and 6-month follow-ups. Researchers will use various clinical tools to measure changes in activity performance, participation, quality of life, self-efficacy, motor function, cognition, and goal attainment. Qualitative interviews will also explore participant and caregiver experiences and satisfaction. The total involvement spans from baseline through six months after treatment, with continuous monitoring and data analysis to evaluate the interventions' impact.

Researchers are evaluating the effectiveness and safety of Recombinant Botulinum Toxin Type A (YY001) injections for treating upper limb spasticity in adults who have had a stroke. This randomized, double-blind, multi-center phase II/III study compares YY001 with BOTOX4 and a placebo to better understand treatment options for this condition. Participants will receive a single intramuscular injection of either Recombinant Botulinum Toxin Type A (YY001) with a dose of 200-400 units, BOTOX4 with a dose of 200 units, or a placebo prepared with saline. The study includes three groups: the experimental group receiving YY001, an active-controlled group receiving BOTOX4, and a placebo-controlled group. Each participant receives only one injection during the treatment period. During the study, participants will be monitored at 1, 4, 8, and 12 weeks after treatment through assessments such as the Modified Ashworth Scale (MAS) for spasticity, Physician's Global Assessment, and Disability Assessment Scale (DAS). Researchers will also track any adverse events and the presence of antibodies to the treatment. The primary outcome is the change in MAS score at week 4. The study lasts at least 12 weeks with ongoing safety and efficacy follow-up.

Researchers are evaluating whether combining two non-invasive brain stimulation methods—muscle stimulation of the arm using functional electrical stimulation (FES) and neurostimulation through the tongue—can improve recovery after stroke. This study focuses on adults who have experienced a stroke and have upper extremity motor impairments, aiming to measure changes in motor function and brain plasticity using behavioral tests and functional MRI scans. Participants are divided into several groups including stroke patients with upper extremity impairments receiving EEG-guided brain-computer interface (BCI) training combined with muscle and tongue stimulation, stroke patients receiving traditional rehabilitation before starting BCI-FES-tongue therapy, stroke patients receiving standard FES therapy only, healthy controls, and people with stroke risk factors. The study involves training sessions with the EEG-BCI system, muscle and tongue stimulation, and the use of the recoveriX system, which provides real-time visual and tactile feedback paired with imagined hand movements. The intervention periods vary, with some groups receiving delayed therapy and others immediate BCI therapy. Participants will undergo multiple assessments including behavioral tests of upper extremity function, EEG recordings, and functional MRI scans at the start and after about four months of therapy. The researchers will monitor changes in arm function using the Action Research Arm Test and observe brain activity changes through EEG and fMRI. The study includes up to six BCI training sessions and regular evaluations over approximately 10 weeks, with some groups receiving additional follow-up MRI and behavioral testing. Safety screening excludes those with allergies to electrode materials or contraindications for MRI, and pregnant women are not eligible.

This research aims to evaluate a digital treatment combining an iPad-based cognitive training program called AKL-T01 with metacognitive strategy coaching to improve executive dysfunction, depression symptoms, and daily function in individuals who have experienced a stroke. The study focuses on those with post-stroke depression and executive dysfunction, conditions linked to ongoing mood and cognitive challenges. Researchers will assess whether this combined treatment enhances brain connectivity and overall functioning compared to a control group. Participants in the intervention group will use the AKL-T01 program for 25 minutes a day, five days a week, over six weeks. This program involves multitasking exercises in a video game-like environment using an iPad. Alongside this, they will receive weekly 45-minute coaching sessions with a clinician to reflect on their experiences and develop strategies for daily activities. The control group will engage in general cognitive games on the iPad for the same duration and frequency, also paired with similar coaching sessions. Throughout the study, participants will undergo assessments at the start and end of the six-week treatment period. These include tests measuring executive function, depression symptoms, daily functioning, and brain connectivity through MRI scans. Researchers will monitor adherence to the treatment and evaluate changes using standardized tools such as the Oral Symbol Digit Modalities Test, Montgomery Asberg Depression Rating Scale, and resting state functional MRI. The total study duration for each participant is six weeks.

Adults with cerebral palsy (CP) often face difficulties in accessing exercise programs tailored to their needs due to limited mobility, lack of suitable options, and restricted physiotherapy access. Regular exercise is important for improving physical health, mental well-being, and overall quality of life, but many adults with CP do not have structured opportunities for physical activity. This research aims to evaluate the feasibility of delivering an accessible online exercise program designed specifically for adults with CP, focusing on demand, practicality, acceptability, and potential benefits to physical, mental, and social health. The study will recruit 60 adults with CP who will be randomly assigned to one of two groups. One group will participate in an 8-week online exercise and education program that includes weekly online exercise classes targeting strength, balance, and range of movement, along with educational materials covering topics like exercise, nutrition, fatigue, bone health, pain management, mental health, and sleep. The other group will receive the same educational materials over 8 weeks without the exercise classes and will be informed about the home exercise program after the intervention period. Participants will be monitored throughout the study with data collected on attendance, completion rates, engagement with exercises, and any adverse events. Health-related surveys will be completed before and after the program to assess changes in physical function, mobility, pain, fatigue, sleep, self-efficacy, depression, and participation. Selected participants will also provide feedback through interviews. The study duration includes rolling recruitment over 1.2 years and outcome measurements over 2 years, aiming to support the development of effective online exercise programs for adults with CP.

Researchers are evaluating the effectiveness of a smart upper limb rehabilitation system combined with exoskeleton robot devices and an Internet of Things (IoT) application for home-based training in patients recovering from stroke and those with spinal cord injuries. The study aims to improve motor function, daily living activities, and quality of life by remotely monitoring rehabilitation progress and assisting patient movements. Participants are adults aged 20 to 79 years with specific cognitive and physical criteria depending on their condition. Participants are randomly assigned to one of two groups: the TIGER group, which uses a tenodesis-induced-grip exoskeleton robot system, or the TOT group, which receives task-oriented training. Each group follows a home-based training program for 4 weeks. For stroke patients, training is 30 minutes twice daily, 5 days a week; for spinal cord injury patients, training is 40 minutes once daily, 5 days a week. The TIGER system offers passive range of motion warm-up and functional training, while the TOT group practices sensorimotor techniques and functional tasks. Participants will undergo assessments before and after the intervention, including motor function tests like the Fugl-Meyer Assessment and Box and Block Test, range of motion measurements, and quality of life evaluations. Researchers will monitor progress in motor activity, independence, and satisfaction with assistive technology. The total study duration spans from baseline through 4 weeks of training, with outcome measures collected at baseline and after the intervention period.

Researchers are studying brain activation patterns in stroke patients during mirror movement to understand upper limb function. This observational study focuses on patients who have had their first stroke, either cerebral infarction or cerebral hemorrhage, with specific muscle strength and muscle tone conditions. The study takes place in a hospital rehabilitation ward where patients receive detailed information and provide informed consent before participation. The study involves two types of hand movements: mirror image and healthy hand movement. In the mirror image intervention, patients place their affected hand in a mirror box and observe the reflection of the healthy hand moving, imagining the affected hand performing the same actions. In the healthy hand movement intervention, patients quickly open and grasp their healthy hand while focusing on the affected hand. The primary outcome is brain activation measured by functional near-infrared spectroscopy (fNIRS) after one week of hand function rehabilitation training. Participants will be closely monitored throughout the trial with full communication and support from the research team. The study involves observing brain activation and hand movement activity with attention to patients' questions and responses. The total participation period includes the initial week of rehabilitation training followed by assessments to measure the brain's response to the interventions.

Researchers are investigating neural biomarkers that may help track and predict recovery of movement and walking ability in patients after a stroke. This study focuses on both natural walking and enhanced therapy using a robotic device. Understanding these biomarkers could improve personalized rehabilitation and recovery outcomes for stroke survivors who often face long-term motor impairments like difficulty walking and balance problems. The study involves training stroke patients with an overground wearable robotic device across 12 treatment sessions. Evaluations occur before treatment, after the 12 sessions, and one month later. During the first and last sessions, brain and muscle activity, as well as ground reaction forces, are recorded using EEG, EMG, and force sensors to monitor progress and interaction with the robotic device. Participants will undergo motor and cognitive assessments commonly used in clinical practice at multiple time points. Researchers will measure motor outcomes from enrollment through the end of treatment at 4 weeks and at a 4-week follow-up. The study aims to gather detailed data on brain-muscle connectivity and mobility improvements to better understand and optimize robotic gait rehabilitation after stroke.