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Found 7 Actively Recruiting clinical trials

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Actively Recruiting

This research aims to evaluate the drug BMS-986368 for treating post-stroke spasticity in adults who have experienced a stroke. Post-stroke spasticity is a common complication that causes muscle tightness and spasms, impacting upper-limb function and quality of life. Current treatments may not fully control symptoms or have tolerability issues, so this study explores BMS-986368 as a potential new therapy based on early clinical and preclinical evidence. Participants will be randomly assigned to receive either BMS-986368 or a placebo during an 8-week double-blind treatment period. The drug dose will increase from 1 mg once daily to 3 mg and then 6 mg once daily. After this period, participants may join an optional 8-week extension where all receive the active drug, still under blinded conditions. The study includes a screening period lasting up to 4 weeks and a 4-week safety follow-up, making the total duration about 24 weeks. Throughout the study, participants will undergo assessments such as the Tardieu Scale and Upper Limb Fugl-Meyer Assessment to measure spasticity and motor function at weeks 8 and 16. Additional evaluations include safety monitoring through adverse event tracking, questionnaires on mood, and blood tests for drug levels. Researchers will closely monitor tolerability and safety during and after treatment to understand the effects of BMS-986368 in adults with post-stroke spasticity.

Age: 18Years - 80YearsAll GendersPhase 2
1 location
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Actively Recruiting

Researchers are evaluating the safety and effectiveness of different doses of Corabotase also called IPN10200 for treating adults with upper limb spasticity. This study aims to understand how Corabotase affects the body and to determine which doses provide the best balance of safety and benefit. The trial involves adult participants aged 18 to 70 years who have spastic hemiparesis following stroke or traumatic brain injury and meet other specific health criteria. The study includes several groups receiving different doses of Corabotase, Dysport, or placebo as single injections into various upper limb muscles. Participants are assigned randomly to groups, with some in dose-escalation cohorts and others in fixed-dose groups. The injections are given once, and doses are carefully adjusted to assess safety and response. The trial uses a double-blind design, meaning neither participants nor researchers know who receives which treatment. Participants will be monitored over nine months with regular assessments including physical exams, vital signs, lab tests, and evaluations of muscle spasticity using the Modified Ashworth Scale. Researchers will track any side effects, antibody development, and changes in muscle tone and disability. Patient and physician impressions of treatment effects and pain levels will also be recorded. This long-term follow-up helps researchers understand how the treatments work and their safety over time.

Age: 18Years - 70YearsAll GendersPhase 1Phase 2
81 locations
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Actively Recruiting

Healthy Volunteer

Researchers are investigating whether nightly eye drops containing 0.05% atropine can delay the onset of nearsightedness myopia in children aged 6 to 11 years who are at high risk of developing this condition. This study compares atropine drops to placebo drops in a randomized clinical trial involving 606 children across multiple centers. The main goal is to measure the two-year cumulative incidence of myopia and to see if atropine slows eye growth. Participants will be randomly assigned to receive either 0.05% atropine eye drops or placebo drops nightly in both eyes at bedtime. The study will last at least two years, during which children will be monitored every six months to assess the onset of nearsightedness and changes in eye growth. The atropine solution is specially prepared by a pharmacy, and the placebo matches the treatment minus the atropine. Throughout the study, children will visit the clinic every six months for eye exams using tools like the Myopia Master to measure eye shape and vision changes. Researchers will track the development of myopia, axial elongation, and progression of refractive error. Safety and adherence will be monitored, including a run-in period to ensure compliance with daily drops. The total participation time is at least two years, allowing thorough evaluation of the treatments effects.

Age: 6Years - 11YearsAll GendersPhase 3
14 locations
S

Actively Recruiting

Researchers are evaluating the Q Therapeutic System BQ 3.0, a wearable medical device that delivers very low-intensity, frequency-tuned electromagnetic fields to stimulate brain networks. This study aims to assess whether this treatment can reduce disability and promote recovery in adults who have experienced an ischemic stroke. The study is conducted across multiple centers and compares active treatment with a sham inactive device in a randomized, double-blind design. The study begins 4 to 21 days after the stroke event. In the first stage up to day 90 post-stroke, participants receive either active or sham treatments five times a week, totaling at least 45 sessions. In the second stage day 90 to day 180, all participants who completed stage 1 can continue to receive active treatments up to five times weekly. In the third stage day 180 to day 270, no treatments are given, and participants are monitored until the final visit. Each session lasts about 60 minutes, including 40 minutes of device use combined with a home-based exercise program. Participants will be trained, with caregiver support as needed, to use the device and perform exercises at home. The study team provides periodic remote supervision and technical support. Assessments of recovery and function will occur at multiple points, including days 45, 90, 180, and 270 after the stroke. Researchers will monitor safety by recording any adverse events or device issues. Usual medical care continues alongside the study treatments throughout the participation period.

Age: 22Years - 80YearsAll GendersPhase Not Applicable
14 locations
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Actively Recruiting

Researchers are evaluating GetUp&Go, a program designed to increase physical activity in adults who are at least six months past a moderate-to-severe traumatic brain injury TBI. This randomized controlled trial aims to determine whether participants who start the 10-week GetUp&Go program immediately show greater increases in physical activity and improvements in mental and physical health compared to those placed on a waitlist. The study also explores whether continued use of the programs mobile health app, RehaBot, helps maintain physical activity gains, and examines how individual participant characteristics affect treatment response. The study involves a 10-week intervention where participants receive personalized physical activity plans supported by one-on-one sessions with a therapist twice weekly via videoconference, plus additional check-ins. After this phase, all participants enter a 10-week follow-up where they are randomly assigned to either continue using the RehaBot app without therapist contact or stop using it. Participants on the waitlist initially have no treatment but receive the full program after their wait period. Participants will take part in baseline and follow-up assessments measuring physical activity objectively through accelerometers, and self-reported measures including fatigue, sleep quality, pain, emotional function, and health-related quality of life. Researchers monitor sedentary behavior and moderate-to-vigorous physical activity levels at multiple timepoints to evaluate the programs effects. The total study timeline includes the initial 10-week treatment or waitlist phase and a 10-week follow-up phase, with evaluations after each period.

Age: 18Years +All GendersPhase Not Applicable
1 location
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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
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Actively Recruiting

This research study is focused on people who have arm weakness due to a stroke that occurred 90 to 150 days earlier. The study aims to find out if adding telerehabilitation TR to usual care can improve arm function and reduce overall disability better than usual care alone. It is a randomized, controlled, and assessor-blinded trial evaluating this treatment approach for stroke recovery. Participants will be randomly assigned to either receive telerehabilitation plus their usual care or to continue with usual care alone. The telerehabilitation involves 70 minutes per day of arm-targeted activities, including exercises, games, and stroke education, for 6 days a week over 6 to 8 weeks. Half of these sessions are supervised remotely by licensed therapists via videoconferencing, while the other half are completed independently. The usual care group will be offered telerehabilitation after the study ends. The study lasts about 8 months and includes 4 in-person visits during which various assessments are performed, including arm function tests and one MRI brain scan. Researchers will measure changes in arm function using the Action Research Arm Test and examine disability with the modified Rankin Scale. Participants progress and safety will be monitored throughout, and the study will evaluate how telerehabilitation impacts recovery after stroke.

Age: 18Years - 80YearsAll GendersPhase Not Applicable
27 locations