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Found 8 Actively Recruiting clinical trials
Actively Recruiting
Clinical Validation of an Instrumented Glove for Sensorimotor Rehabilitation After Stroke DESC-Glove
Researchers are evaluating the DESC-Glove, a special instrumented glove designed to aid sensorimotor rehabilitation in people recovering from a stroke. The study aims to assess the gloves technical function, safety, and reliability during rehabilitation. It also explores how usable and acceptable the device is for both patients and healthcare professionals, as well as its short-term effects on hand movement and dexterity. The study has two phases. Phase 1 tests the DESC-Glove on 5 patients through four treatment sessions involving fine and gross motor exercises for the hand and upper limb. Patients wear the glove on their affected hand and receive synchronized vibrational feedback. Phase 2 is a larger randomized trial with 42 participants divided into three groups one uses the DESC-Glove with vibration, another uses it without vibration sham, and the last receives conventional hand rehabilitation without the glove. Treatments consist of two 20-minute sessions per day, three times a week, over four weeks. Participants will undergo various assessments including tests of hand dexterity and arm function before and after the treatment period. Researchers will monitor device malfunctions and dropouts related to the device after each session. Questionnaires will collect feedback on the gloves usability and acceptance. The study includes weekly and final evaluations to measure changes in sensorimotor performance and manual dexterity, providing comprehensive data on the gloves impact during post-stroke rehabilitation.
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Healthy Volunteer
This research investigates the feasibility, acceptability, usability, and initial validation of StimolIrpinia, a multimedia collection of autobiographical and culturally relevant materials from the Irpinia region in Italy. It aims to support cognitive rehabilitation in adults with severe acquired brain injury sABI, who often face impairments in memory, attention, language, and other cognitive functions. The study includes both healthy adults to validate the stimuli and hospitalized sABI patients to assess usability during rehabilitation. Patients with sABI will participate in six 30-minute cognitive rehabilitation sessions over two weeks using StimolIrpinia alongside their regular rehabilitation program. The multimedia repository includes images, videos, maps, local cultural facts, and printable materials that rehabilitation professionals personalize based on each patients background and cognitive needs. Rehabilitation staff receive training to integrate these materials into exercises targeting memory, orientation, language, and recognition. Participants will be evaluated through patient and professional feedback on usability and acceptability after the intervention. Assessments include standardized scales completed at day 15 and up to 12 months for professionals. The study tracks cognitive stimulation effects, emotional response, and user experience. This involves questionnaires, qualitative feedback, and routine clinical monitoring during and after the two-week treatment period.
Actively Recruiting
Researchers are evaluating rehabilitation methods for patients who have had a stroke within the past six months. The study aims to compare rehabilitation using Robot and Allied Digital Technologies RADTs with traditional rehabilitation, focusing on the recovery of daily living activities. This multicenter randomized controlled trial seeks to determine if rehabilitation with RADTs is not worse than traditional methods, while also exploring potential benefits, usability, and economic sustainability. Participants will be randomly assigned to one of two groups. The experimental group receives rehabilitation with RADTs, involving devices for upper and lower limb motor skills, gait, balance, and cognitive abilities, supervised by two physical therapists managing 4 to 6 patients. The control group undergoes traditional one-on-one rehabilitation targeting the same domains without robotic devices. Both groups complete 25 sessions of 45 minutes each, with inpatient treatments held five times a week for five weeks and outpatient treatments three times a week for about eight weeks. Throughout the study, participants will have various assessments including the modified Barthel Index to measure daily living activities, motor and sensory function tests, balance scales, cognitive tests, pain scales, and neurophysiological and biomarker evaluations. Follow-up evaluations will continue monthly for six months after treatment. Data are collected uniformly across centers to assess effectiveness, patient and caregiver acceptance, and economic impact of the rehabilitation methods.
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Researchers are investigating the effectiveness of robotic assisted verticalization plus mobilization VEM compared to traditional verticalization TV for patients with severe Acquired Brain Injury sABI. The study focuses on helping patients regain the ability to maintain an upright position, which is crucial for preventing complications from immobility and improving cognitive and muscular function. Prior research shows mixed results due to small or varied patient groups, so this large multicenter study aims to provide clearer evidence using standardized assessments.
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This research aims to identify medium-term factors that influence recovery for patients with Severe Acquired Brain Injuries. It also seeks to develop a continuous system to assess the quality of care provided by rehabilitation units treating these patients. The study focuses on understanding key outcomes important to rehabilitation success. Data will be collected from each participating rehabilitation unit, including information about their structure and organization. Detailed patient data will be gathered upon admission to these units and then re-evaluated four months after their acute brain injury event. Statistical models will be used to predict the likelihood of achieving three key rehabilitation goals removal of tracheostomy tubes, trunk control, and full feeding by mouth. Participants will be adults admitted to these specialized rehabilitation units between July 2021 and December 2023. Patients admitted more than 14 weeks after their acute injury will not be included. Researchers will monitor patients for up to four months post-injury to evaluate the main outcomes. The study will help understand patient progress and care quality in these rehabilitation settings.
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Healthy Volunteer
Researchers are exploring the use of spontaneous eye blinking characteristics to help diagnose and predict recovery in patients with Disorders of Consciousness DoC after severe acquired brain injury sABI. This multi-center, prospective observational study involves adults with DoC, including Unresponsive Wakefulness Syndrome UWS and Minimally Conscious State MCS, admitted to several European neurorehabilitation centers. The study focuses on improving diagnostic and prognostic tools by examining eye blink parameters such as rate, amplitude, duration, and variability. Participants include 70 patients with DoC and a reference group of 23 healthy volunteers balanced by age and sex. Each patient undergoes two 20-minute EEG-EOG resting examinations within two weeks of study entry, spaced 24 hours apart, with recordings made while awake and in a quiet environment. Eye blinking is monitored at the bedside or in a wheelchair, with arousal facilitation protocols used if needed. A six-month follow-up assessment is also planned to evaluate outcomes. During the study, patients are assessed using the Coma Recovery Scale-Revised CRS-R before and after EEG-EOG recordings. Data collection follows routine clinical practice without deviations. Researchers will analyze blink features and clinical scores to evaluate diagnostic and prognostic value. The study spans approximately 24 months with enrollment over 12 months, and safety monitoring includes repeated EEG sessions if artifacts occur. Healthy volunteers also undergo two EEG-EOG sessions to provide comparison data.
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Researchers are evaluating the effectiveness of a home-based telerehabilitation program using digital tools compared to a traditional educational program for patients with disabilities following a stroke. The study focuses on whether this digital neuromotor and cognitive rehabilitation improves static and dynamic balance better than usual care. This multicenter, randomized, controlled trial aims to assess improvements measured by the Berg Balance Scale in patients with subacute and chronic stroke. Participants will be randomly assigned to one of two groups. The experimental group will follow a 6-week remote telerehabilitation program involving task-oriented balance exercises, performed both standing and seated, with complexity tailored to individual progress. One session per week is supervised remotely by a therapist, while other sessions are completed independently. The control group will follow a 6-week self-guided educational program supported by printed materials, with weekly phone calls and an activity diary to monitor progress. During the study, participants will undergo assessments at the start and within seven days after completing the 6-week program. These include balance tests, motor and sensory function evaluations, cognitive assessments, pain scales, and functional mobility measures. Data will be collected using a standardized platform, and the researchers will monitor adherence, acceptability, usability, and economic sustainability of the digital intervention. The total participation lasts for six weeks of treatment plus assessments.
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Researchers are investigating whether tickling can have a short-term effect on patients with Disorders of Consciousness DoC caused by Severe Acquired Brain Injury. The study compares responses to tickling with responses to neutral touch that does not cause tickling, aiming to understand patient responsiveness. This observational research includes behavioral and physiological monitoring to explore neural activity during these stimulations. During the experimental session, patients will undergo assessments using the Coma Recovery Scale-Revised CRS-R and the Nociception Coma Scale-Revised NCS-R to ensure responses are not influenced by pain. Non-invasive brain monitoring with fNIRS and EEG via SedLine will be used. Patients will receive manual tickling and neutral touch on specified body areas in a randomized order, with recordings before, during, and after the stimulations. Participants will be monitored for facial expressions, vocalizations, body movements, and emotional changes during the session, which lasts about one hour and fifteen minutes. The study measures behavioral responses from video analysis, brain blood flow changes via fNIRS, and cortical EEG activity. These outcomes will help assess responsiveness in DoC patients, with careful safety monitoring throughout the single-session protocol.