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Found 4 Actively Recruiting clinical trials

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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.

Age: 18Years +All GendersPhase Not Applicable
1 location
L

Actively Recruiting

Researchers are studying adults in the Lombardy region who have subjective cognitive decline SCD, functional cognitive disorder FCD, or are well worried without objective cognitive impairment. The study aims to understand the clinical, cognitive, and biological characteristics of these individuals, especially focusing on differences between those with positive and negative Alzheimers disease AD plasma biomarkers. It also examines factors predicting biomarker status, the psychological effects of sharing biomarker results, and how biomarkers relate to cognitive changes over time. Participants will attend Brain Health Services BHS where they will undergo standard clinical evaluations and provide blood samples for plasma biomarker analysis, including markers like p-tau217, GFAP, NfL, and ApoE. They will also complete neuropsychological tests and questionnaires about psychological impact before and after receiving biomarker information. Additional procedures such as MRI, lumbar puncture, or polysomnography may be done if clinically needed. The study plans annual follow-up visits over five years. During the study, participants will be assessed through clinical evaluations, blood tests, cognitive screenings, and psychological questionnaires. Researchers will monitor biomarker changes and psychological well-being after disclosure of biomarker results. The main outcome is to identify clinical and biological patterns related to AD biomarker positivity at the first visit. The total study duration is seven years, including recruitment and follow-up, aiming to support better prevention strategies in brain health services.

Age: 18Years +All Genders
5 locations
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Actively Recruiting

Researchers are investigating the safety, reliability, and short-term effects of gait training using the SHAJA unilateral hip exoskeleton in adults who have had a stroke. This clinical trial aims to determine if SHAJA-based training improves walking speed and endurance better than conventional gait training. The study also evaluates the devices safety and reliability during rehabilitation. Participants will be randomly assigned to two groups. One group will first complete six sessions of SHAJA-assisted gait training followed by six sessions of conventional gait training, while the other group will do the opposite sequence. Each gait training session involves overground walking for 30 to 40 minutes, either with the SHAJA exoskeleton or without it. The trial includes two treatment periods and multiple assessment visits. During the study, participants will have five evaluation sessions to measure walking speed, endurance, gait characteristics, balance, and muscle strength. Assessments include the 10 Metre Walk Test, Walk Test, Timed-Up-and-Go test, and various clinical scales. Researchers will monitor for device-related issues and adverse events from before training until about three months afterward. The total follow-up lasts approximately 14 weeks after the initial evaluation.

Age: 18Years - 80YearsAll GendersPhase Not Applicable
2 locations
E

Actively Recruiting

Researchers are evaluating the effectiveness of the Gloreha Sinfonia4 robotic exoskeleton for upper limb rehabilitation in people who have experienced subacute post-stroke paresis. This international multicenter randomized controlled trial aims to compare robotic-assisted therapy combined with conventional rehabilitation against conventional therapy alone. The main goal is to see if robotic therapy improves voluntary motor control and coordination better, measured by the Fugl-Meyer Assessment for the upper limb motor function. Secondary goals include assessing muscle strength, range of motion, coordination, manual skill, independence in daily activities, patient satisfaction, and any adverse events. Participants are randomly assigned to one of two groups the Experimental Group EG receives robotic-assisted upper limb rehabilitation along with conventional physical and occupational therapy, while the Control Group CG receives only conventional therapy. Both groups undergo 18 sessions, 3 to 5 times per week, with each daily session lasting 90 minutes. The robotic therapy in the EG progresses through passive, assisted, and active mobilization modes over five weeks, with personalized adjustments based on motor ability. Conventional therapy includes tailored motor exercises for shoulder, elbow, wrist, and hand. The study includes a recruitment and treatment phase followed by a 3-month follow-up period. Participants will have clinical assessments at baseline, after treatment around 35 days, and at 3 months follow-up around 125 days. Evaluations include motor function scales, muscle strength, spasticity, pain, dexterity tests, independence measures, and patient satisfaction questionnaires. Follow-up assessments may be conducted in person or by phone using remote scales. Data collection is anonymized and securely stored. Researchers will analyze the clinical and demographic data to understand treatment effects, patient response factors, and rehabilitation outcomes over the 36-month study duration.

Age: 18Years - 85YearsAll GendersPhase Not Applicable
21 locations