Sant Angelo Dei Lombardi

Researchers are evaluating the DESC-Glove, a special glove designed to help people recover hand and arm movement after a stroke by providing gentle vibrations during rehabilitation. This study aims to check how well the glove works technically, how safe and reliable it is, and how patients and therapists feel about using it. Additionally, the study will look at whether using the glove can improve hand function and dexterity shortly after stroke. The study has two parts. In the first part, 5 patients will try the DESC-Glove in four treatment sessions involving fine hand and larger arm exercises to test its initial function and patient compliance. In the second part, 42 participants will be randomly divided into three groups: one using the DESC-Glove with vibration, one using the glove without vibration (sham), and one receiving traditional rehabilitation without the glove. Treatments include 24 sessions over 4 weeks, with two 20-minute therapy sessions per day, three days per week. Participants will wear the DESC-Glove on their affected hand during therapy sessions, and researchers will monitor device malfunctions and dropouts shortly after each session. The study will also assess patient and therapist feedback, sensorimotor performance, and manual dexterity. Monitoring will continue through all sessions to ensure safety and gather data for future improvements.

Researchers are evaluating the effectiveness of rehabilitation using Robot and Allied Digital Technologies (RADTs) compared to traditional rehabilitation in patients who have had a stroke within the past six months. This large multicenter randomized controlled trial aims to assess not only recovery of daily living activities but also upper and lower limb abilities, balance, cognitive skills, neurophysiological factors, and the economic sustainability of treatments. The study uses a pragmatic approach with blinded assessors across inpatient and outpatient settings. Participants are randomly assigned to two groups: one receives robotic rehabilitation with two physiotherapists supervising 4 to 6 patients in a gym equipped with advanced devices, while the other group receives traditional one-on-one physiotherapy. Both groups complete 25 sessions of 45 minutes each. Inpatients attend sessions 5 times a week for 5 weeks, and outpatients attend 3 times a week for about 8.3 weeks. Treatments focus on improving sensorimotor functions of upper and lower limbs, gait, balance, and cognitive abilities. During the study, participants' progress is assessed using the modified Barthel Index to measure changes in daily living activities. Researchers also evaluate other motor and cognitive outcomes, neuroplasticity, treatment acceptability, usability, and cost-effectiveness. Standardized procedures and data collection through the REDCap platform ensure consistency. The total study participation includes treatment sessions and follow-up assessments to monitor medium-term effects and safety.

Researchers are investigating the effectiveness of robotic assisted verticalization combined with mobilization (VEM) compared to traditional verticalization (TV) in patients with severe Acquired Brain Injury (sABI). The study focuses on improving recovery of upright posture, cognitive functioning, and preventing complications from immobility in these patients. This multicenter trial addresses previous limitations by enrolling a large, well-defined cohort and using standardized clinical tools and biomarkers to measure outcomes. Participants will receive either robotic assisted verticalization using the Erigo device, which gradually elevates patients and provides passive leg movements, or traditional verticalization involving gradual elevation on a non-robotic tilt table. Both groups will undergo 20 sessions over 4 weeks, with each session lasting 30 minutes. Additionally, all participants will receive a comprehensive 60-minute daily rehabilitation program for three months, including bed positioning, limb mobilization, sensory stimulation, and therapies tailored to patient needs. During the study, patients will be closely monitored for heart rate, blood pressure, oxygen levels, agitation, and pain. Researchers will assess cognitive function, motor abilities, and functional status using validated scales, as well as analyze brain activity through EEG and measure blood biomarkers related to brain recovery. Safety and adverse events will be recorded weekly. The overall participation includes a 4-week intervention with extensive follow-up and monitoring to evaluate the impact of the treatments on recovery.

This research focuses on patients with Severe Acquired Brain Injuries and aims to identify medium-term factors that can predict their rehabilitation outcomes. The study also seeks to develop a continuous system to assess the quality of care provided by rehabilitation units treating these patients. Identifying these prognostic factors helps understand which patients are likely to experience key rehabilitation milestones. Data will be collected from rehabilitation units and will include information about the units themselves and detailed patient data at admission and again four months after the acute brain injury event. The study will use statistical models to analyze the likelihood of achieving important rehabilitation goals such as removal of tracheostomy tubes, trunk control, and feeding entirely by mouth, all evaluated four months after the injury. Participants will be assessed at the start of rehabilitation and then re-evaluated four months later. The study measures include monitoring tracheostomy tube status, trunk control ability, and feeding methods. This allows researchers to track patient progress and evaluate care quality over time. The total participation duration includes the initial admission and follow-up assessments up to four months post-injury.

Researchers are studying patients with Disorders of Consciousness (DoC) following severe acquired brain injury to explore how spontaneous eye blinking features, such as rate, amplitude, duration, and variability, can help distinguish between Unresponsive Wakefulness Syndrome (UWS) and Minimally Conscious State (MCS). This observational, multicenter study takes place across nine European centers and aims to assess the diagnostic and prognostic value of these eye blink parameters in patients with severe brain injuries. The study plans to enroll 70 patients with DoC and 23 healthy volunteers to serve as a comparison group. Patients will undergo two 20-minute resting EEG-EOG recording sessions within two weeks of enrollment, spaced 24 hours apart. The recordings will be done with patients awake and in a quiet, dimly lit environment, monitored by researchers who will encourage relaxation with eyes open. If patients are not sufficiently alert, an arousal facilitation protocol will be used or the session rescheduled. Healthy volunteers will also complete two similar EEG-EOG sessions. The study follows routine clinical practice and patients will be followed up six months after enrollment. During the study, researchers will collect clinical data, perform repeated consciousness assessments using the Coma Recovery Scale-Revised, and analyze eye blink activity from EEG-EOG recordings to investigate relationships with consciousness levels. The main outcome is the clinical diagnosis at six months. The study duration is about 24 months, including 12 months for enrollment, with data collected transparently and safely across multiple centers.

Researchers are evaluating the effectiveness of a home-based telerehabilitation program using digital tools compared to a traditional home-based educational program for patients with disabilities following a stroke. The study focuses on improving static and dynamic balance in patients with subacute and chronic stroke, aiming to demonstrate whether digital rehabilitation is superior to usual care. This is a multicenter, randomized controlled trial involving multiple clinical centers in a national research initiative. Participants will be randomly assigned to one of two groups. One group will receive an integrated treatment with digital tools through a 6-week remote telerehabilitation program, with a minimum of three sessions per week, including one synchronous session with a therapist and the rest asynchronous. The other group will follow a home-based educational program with weekly phone call monitoring and activity diary maintenance for six weeks. Treatment adherence and session completion are monitored. During the study, participants will undergo assessments including the Berg Balance Scale at baseline and after the 6-week intervention to measure changes in balance. Data collection is standardized across centers using an electronic platform. The study also evaluates secondary outcomes such as intervention frequency impact, acceptability, usability, and economic sustainability. Participants are monitored weekly, and treatment progress is tracked through diaries and phone calls, with a total participation duration of six weeks.

Researchers are evaluating the short-term effects of tickling on the responsiveness of patients with Disorders of Consciousness (DoC) caused by Severe Acquired Brain Injury. The study compares responses to tickling versus neutral touch that does not cause tickling. The goal is to understand whether tickling can influence behavioral and physiological reactions in these patients. During the session, patients will first undergo assessments using the CRS-R and Nociception Coma Scale-Revised to ensure responses are not due to pain. Then, non-invasive brain monitoring with fNIRS will be set up using a frontal headband. Patients will receive manual tickling on the soles of the feet, armpits, ribs, and a control area on the forehead, as well as neutral touch on the same areas. Each stimulation lasts 5 seconds, followed by 5 seconds rest, repeated twice, with 1-minute breaks between areas. The order of stimulations is randomized. After stimulation, another 10-minute resting brain recording is done. Participants will be filmed throughout to analyze facial expressions, vocalizations, body movements, and emotional changes like crying or smiling. Brain activity will also be recorded continuously using a portable EEG device called SedLine. The entire experiment lasts about 1 hour and 15 minutes, including assessments and stimulation. Researchers will measure behavioral responses, brain activity patterns, and blood flow changes to better understand how tickling affects patients with consciousness disorders.

Researchers are investigating the effectiveness of non-immersive Virtual Reality (VR) rehabilitation compared to traditional cognitive training (TCT) in patients with severe acquired brain injury (ABI) from various causes, including traumatic or anoxic brain injury. This multicenter randomized controlled trial aims to address limitations in current research such as small sample sizes and mixed patient groups, to provide stronger evidence for VR's role in cognitive rehabilitation after ABI. Participants will be randomly assigned to receive either 30-minute daily sessions of VR-based cognitive rehabilitation using the Khymeia®-Virtual Reality rehabilitation System or traditional face-to-face cognitive training using paper and pencil tools. Both groups will also undergo a comprehensive daily rehabilitation program lasting 60 minutes, including limb mobilization, cognitive training, occupational therapy, language, and swallowing therapy, for 5 weeks with 20 sessions total, five days per week. During the study, participants will be assessed using the Trail Making Test to measure cognitive performance, along with other scales evaluating disability, usability of VR, and functional abilities. Researchers will also collect safety data on adverse events weekly and explore additional biomarkers and neuropsychological tests. The total participation period includes 5 weeks of treatment with ongoing monitoring and follow-up assessments to evaluate the impact of the interventions.