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Found 6 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating the efficacy, safety, and how the body processes pharmacokinetics prasinezumab compared with a placebo in people with early-stage Parkinsons disease PD who are on stable levodopa monotherapy. This Phase III study aims to understand if prasinezumab can affect the progression of motor symptoms in this population. Participants will receive either prasinezumab or a placebo as an intravenous IV infusion during the double-blind treatment period. After completing this phase, eligible participants may enter an open-label extension where they can receive prasinezumab. Infusions are given according to a schedule detailed in the study protocol. Throughout the study, participants will be regularly assessed using the Movement Disorder Society - Unified Parkinsons Disease Rating Scale MDS-UPDRS Part III to monitor motor progression, along with other clinical measures and safety evaluations. Researchers will also track adverse events, antibody development against the drug, and drug levels in the blood. The study includes monitoring up to at least 104 weeks, with safety follow-up extending 70 days after the final dose.
Actively Recruiting
Researchers are evaluating the effects of a robotic rehabilitation treatment called Bilateral Robot-Assisted Therapy BRAT on upper limb motor recovery in people who have had a stroke in the subacute phase. This study compares BRAT combined with standard rehabilitation to conventional arm rehabilitation without robotic assistance. The main goal is to determine if BRAT improves motor function better than traditional therapy, measured by the Fugl-Meyer Assessment for the upper limb. Secondary goals include assessing quality of life and identifying which patients benefit most from BRAT based on age, time since stroke, and severity of motor deficit. Participants will be randomly assigned to either the experimental group EG or the control group CG. The EG will receive standard rehabilitation plus daily 45-minute sessions of BRAT using the Arm Light Exoskeleton Hybrid Alex RS robotic system, completing about 16 treatment sessions over four weeks. The CG will also receive standard rehabilitation plus 45 minutes of conventional upper limb exercises with a therapist, without any robotic devices, for a similar number of sessions and duration. Both groups will receive personalized therapy based on their clinical needs. During the study, participants will be assessed at the start baseline, after treatment completion, and again three months later via telephone follow-up. Evaluations include clinical exams, rating scales like the Fugl-Meyer Assessment, and instrumental measures such as EEG and muscle activity recordings. The study aims to measure motor recovery, muscle activation, cognitive effects, and improvements in daily activities. Safety and satisfaction will also be monitored throughout the 24-month study period.
Actively Recruiting
Researchers are studying neurodegenerative diseases to find new early markers for diagnosis and prognosis. This prospective, observational, longitudinal study collects data from patients with conditions like Parkinsons Disease, Lewy Body Dementia, Alzheimers Disease, and other movement or cognitive disorders. The goal is to improve early diagnosis and predict disease progression using clinical evaluations and advanced tools including artificial intelligence AI. Participants undergo routine clinical examinations over 1 to 10 years. Data collected includes movement analysis with motion capture and wearable sensors, brain imaging, neuropsychological and electroencephalographic assessments, and blood chemistry tests. The study also explores AI-powered methods such as voice analysis and handwriting analysis using commercial devices, aiming to support remote diagnosis and monitoring. During the study, participants will be followed with regular clinical visits where various tests and assessments are performed. Researchers will monitor changes in motor and cognitive functions, analyze brain and blood markers, and use AI models to predict disease course. The study plans to track participants for up to 10 years to better understand progression and improve treatment strategies.
Actively Recruiting
Researchers are studying the use of home telerehabilitation TR based on serious games to help people with Parkinsons Disease PD improve their ability to perform daily activities. This study aims to compare the effectiveness of this TR program with conventional day-hospital rehabilitation treatments. Despite existing standards for TR in physiotherapy, there is limited research on its use specifically for managing motor and non-motor symptoms of PD, which this study seeks to address. Participants are randomly assigned to one of two groups. The Experimental Group will complete 30 sessions of motor, speech, and cognitive rehabilitation exercises at home using the VRRS Tablet system, with sessions scheduled 3 to 5 days per week over 6 to 10 weeks. The Control Group will receive 30 sessions of conventional rehabilitation treatments, including physiotherapy, occupational therapy, speech therapy, and psychotherapy, without technological devices, following the same schedule. Both groups receive 9 hours of rehabilitation per week. During the study, participants will be assessed at the start, at the end of treatment around 10 weeks, and at 2 months post-treatment. Evaluations include the MDS-Unified Parkinsons Disease Rating Scale MDS-UPDRS, Parkinsons Disease Questionnaire-8 PDQ-8, Montreal Cognitive Assessment MoCA, speech and motor tests, and balance and walking assessments. Researchers will monitor changes in motor and non-motor symptoms, quality of life, and functional abilities. The study continues until March 2026.
Actively Recruiting
Researchers are studying how different amounts of aerobic exercise affect brain-derived neurotrophic factor BDNF levels in people with Parkinsons disease. This pilot observational study compares two rehabilitation exercise programs with different energy expenditures to see how they influence BDNF and other biomarkers, motor and non-motor symptoms, brain activity, and connectivity. The goal is to understand the dose-response relationship between exercise volume and these changes. Participants are divided into two groups the Extensive Rehabilitation Group will perform 45-minute sessions of low-intensity aerobic exercise twice a week, totaling 180 METs-minutes per week. The Intensive Rehabilitation Group will do 45-minute sessions of high-intensity aerobic exercise five days a week, reaching 1350 METs-minutes per week. Both exercise programs last for 4 weeks. During the study, participants will undergo blood tests to measure BDNF and other peripheral biomarkers at 4, 8, and 12 weeks. Researchers will also assess motor symptoms, cognitive function, quality of life, gait parameters, cortical activity using EEG, and brain connectivity with fMRI. The study involves monitoring changes over time to evaluate how exercise intensity influences these health markers in Parkinsons disease patients.
Actively Recruiting
This research aims to evaluate how well an end-effector robotic device improves upper limb movements, strength, and coordination in people with mild to moderate Parkinsons disease, compared to conventional rehabilitation. Parkinsons disease is a progressive neurological disorder causing motor symptoms such as slow movement, tremor, and rigidity, which affect daily life and quality of life. While physical rehabilitation helps, evidence on hand dexterity improvements is limited, and robotic therapy offers a new approach to target upper limb function. Participants will be randomly assigned to one of two groups an experimental group receiving 20 sessions of robotic-assisted upper limb therapy using the Motore device, combined with standard rehabilitation or a control group receiving 20 sessions of conventional upper limb rehabilitation with a therapist, also combined with standard care. Each session lasts 45 minutes and occurs three times per week. The robotic therapy involves exercises with visual and force feedback to assist or resist movements of the shoulder, elbow, and wrist, including serious games for motor control, coordination, and cognitive training. During the study, participants will be assessed at baseline and after treatment day 50 using tests like the Box and Block Test, Action Research Arm Test, and Unified Parkinsons Disease Rating Scale to measure upper limb function and coordination. Follow-up evaluations will occur three months post-treatment. Researchers will also monitor participant satisfaction and system usability. The study lasts about three months, with careful tracking of treatment effects and participant compliance.