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Found 5 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating the effects of a robotic rehabilitation treatment using a bilateral exoskeleton called Bilateral Robot-Assisted Therapy (BRAT) during standard rehabilitation in people who have experienced a stroke in the subacute phase. The study compares BRAT to conventional arm re-education to understand its effectiveness in improving upper limb motor function, measured by the Fugl-Meyer Assessment for the upper limb. This randomized controlled trial aims to identify if BRAT provides better motor recovery compared to standard rehabilitation and also explores the impact on quality of life and bilateral arm motor skills. Participants are randomly assigned to either the Experimental Group (EG) or the Control Group (CG). The EG receives standard rehabilitation plus one daily 45-minute BRAT session using the Arm Light Exoskeleton Hybrid (Alex RS - Wearable Robotics) robotic system, with a total of approximately 16 treatment sessions over four weeks. The CG receives standard rehabilitation plus 45 minutes of conventional upper limb exercises with a therapist, including passive, active-assisted, and active exercises, also totaling about 16 sessions over four weeks. The BRAT sessions include device setup, unilateral and bilateral upper limb training with visual and motor feedback. During the study, participants undergo clinical and instrumental evaluations at baseline and after the treatment period. Assessments include clinical rating scales and objective examinations, with a follow-up telephone evaluation three months after treatment ends. The primary outcome measure is the Upper Limb Fugl-Meyer Assessment motor score at baseline and day 28. Researchers will also study neurophysiological and biomechanical effects using EEG, sEMG, and inertial measurement units. The study spans 24 months including enrollment, treatment, and data analysis phases.
Actively Recruiting
Researchers are investigating neurodegenerative diseases by collecting extensive data from patients during their routine clinical visits. This long-term observational study aims to identify early markers for diagnosis and prognosis by analyzing clinical evaluations, movement patterns, brain imaging, neuropsychological tests, EEG assessments, and blood chemistry. It focuses on diseases such as Parkinson's, Lewy Body Dementia, Alzheimer's, and other related disorders, with an emphasis on understanding the progression and variability of these conditions. Participants will be followed for up to 10 years with routine assessments that include quantitative movement analysis using motion capture and wearable sensors, AI-driven analysis of handwriting and voice, brain imaging supported by machine learning, and laboratory tests including blood and microbiota analysis. The study explores innovative AI tools for remote monitoring and telemedicine applications to support diagnosis, follow-up, and therapy management. Throughout the study, participants will undergo frequent clinical and neuropsychological evaluations, movement and voice analyses, brain scans, and blood tests. Researchers will use these data to develop predictive models and new diagnostic markers. The study aims to enhance early detection and improve treatment strategies by closely tracking disease progression over time, with continuous safety and outcome monitoring lasting from baseline up to 120 months.
Actively Recruiting
Researchers are evaluating the effectiveness of a home telerehabilitation program using serious games for people with Parkinson's Disease (PD). The study aims to assess how this remote therapy impacts patients' ability to carry out daily activities compared to conventional day-hospital rehabilitation. Parkinson's Disease causes motor and non-motor symptoms, and while exercise can help manage these, access to rehabilitation centers can be difficult due to logistical and economic barriers. Participants will receive either a telerehabilitation program using the VRRS Tablet, which provides motor, speech, and cognitive exercises through serious games with visual and auditory feedback, or conventional rehabilitation that includes physiotherapy, occupational therapy, speech therapy, and psychotherapy without technological devices. Both treatments are customized by specialists based on patient needs and last 9 hours per week. The telerehabilitation uses sensors to monitor movements like balance and lower limb exercises, while conventional therapy is delivered in person. During the study, researchers will measure changes in the participants' motor function using the MDS-Unified Parkinson's Disease Rating Scale at baseline, after about 10 weeks of treatment, and again 2 months later. Patients will be monitored for improvements in daily living activities and overall motor symptoms. The study includes assessments of cognitive function, compliance, and safety, with ongoing support from caregivers during telerehabilitation sessions. The total participation period includes treatment and follow-up evaluations.
Actively Recruiting
Researchers are investigating how different amounts of aerobic exercise affect blood levels of brain-derived neurotrophic factor (BDNF) in people with Parkinson's disease. This pilot study aims to understand the dose-response relationship between exercise volume and BDNF changes. It also explores how these exercise programs impact other neurotrophic factors, motor and non-motor symptoms, gait, cognitive function, quality of life, brain activity, and brain connectivity using EEG and fMRI. Participants will be divided into two groups based on exercise volume: an Extensive Rehabilitation Group performing 180 METs-minutes per week and an Intensive Rehabilitation Group performing 1350 METs-minutes per week. The aerobic exercise is standardized and measured by energy expenditure in METs-minutes per week. This observational study tracks changes over a 4-week exercise training period. During the study, participants will undergo assessments including blood sampling to measure BDNF levels at 4, 8, and 12 weeks. Other evaluations include motor and cognitive assessments, gait analysis, quality of life questionnaires, and brain imaging with EEG and fMRI. The study monitors safety and clinical responses while tracking the effects of different exercise volumes on peripheral biomarkers and brain connectivity over time.
Actively Recruiting
This research aims to evaluate the effectiveness of an end-effector robotic device designed to improve upper limb movements, strength, and coordination in people with Parkinson's disease (PD) who have mild to moderate disability. The study compares this robotic therapy to conventional rehabilitation treatment. Parkinson's disease is a progressive neurological disorder that causes motor symptoms like slowed movement, tremors, and muscle stiffness, as well as non-motor symptoms affecting quality of life. Upper limb motor impairment in PD affects daily activities, and while current treatments help early on, their effectiveness decreases as the disease advances. Robotic rehabilitation offers a promising approach by providing targeted, task-specific therapy based on neuroplasticity and motor learning principles, but evidence in PD upper limb therapy is limited and needs further research. Participants will be randomly assigned to one of two groups: the experimental group (EG) receiving 20 sessions of robot-assisted therapy focused on shoulder, elbow, and wrist movements, using a device that supports and assists limb movement with visual and force feedback; and the control group (CG) receiving 20 sessions of conventional rehabilitation without devices, focusing on mobility, coordination, and manual dexterity exercises led by a therapist. Each session lasts 45 minutes, with the robotic sessions including 20 minutes per upper limb plus setup time. Exercises include motor control, coordination, cognitive training, and simulations of daily activities. During the study, participants' upper limb function will be assessed at baseline and after 50 days using tests including the Box and Block Test (BBT). Researchers will also evaluate upper limb coordination and functionality with additional scales, study participants' compliance and satisfaction with the robotic system, and analyze effects on quality of life. The study will identify subgroups that might benefit more from robotic therapy based on disease stage and other factors. Participants must complete all assessments and follow the treatment schedules throughout the study duration.