Elkins Park

Researchers are evaluating the safety and effectiveness of increasing doses of IPN10200 to understand its pharmacodynamics and identify the best dose for treating adults with upper limb spasticity. This integrated Phase I/II, multicenter, double-blind, randomized study also compares IPN10200 with Dysport and placebo to find the optimal balance of efficacy and safety in adults aged 18 to 70 years with spastic hemiparesis following stroke or traumatic brain injury. Participants receive either IPN10200, Dysport, or placebo as a powder and solvent solution for injection. The study includes dose escalation and dose-finding phases to assess different dosing levels. Treatments are administered in the affected upper limb muscles, with eligibility based on specific muscle tone and spasticity angle criteria. The study monitors participants for up to 9 months, including a safety follow-up period. During the study, participants undergo regular assessments including vital signs (blood pressure and heart rate), clinical lab tests, physical examinations, and monitoring for treatment-emergent adverse events and antibodies to the study drugs. Researchers use these measures to evaluate safety and treatment effects over the 9-month period from baseline through the end of the study.

Researchers are evaluating whether nightly eye drops containing 0.05% atropine can delay the onset of nearsightedness in children at high risk for developing myopia. This randomized clinical trial involves children aged 6 to 11 years and aims to compare atropine drops to placebo drops over two years. The study also investigates whether atropine treatment slows eye growth, which is related to myopia progression. This is a phase 3, multicenter study recruiting 606 children from 14 clinical centers. Participants will be randomly assigned to receive either atropine sulfate 0.05% eye drops or placebo drops, both administered nightly in both eyes. The drops are compounded to ensure the placebo matches the treatment minus the atropine. The study includes a run-in period where participants must demonstrate adherence by using artificial tears at least 90% of the time. Participants are followed every six months for at least two years to monitor the development of nearsightedness and eye growth. Throughout the study, children will undergo regular eye exams including cycloplegic autorefraction and measurements of axial length using a device called Myopia Master. Researchers will track the incidence of myopia and changes in eye length over two years. Safety and adherence are monitored closely, and participants who meet the eligibility requirements at screening and baseline visits continue in the trial. The total participation time is at least two years with visits every six months to assess eye health and treatment effects.

Researchers are evaluating the Q Therapeutic System (BQ 3.0), a wearable medical device that delivers low-intensity, low-frequency electromagnetic fields to stimulate brain networks. The goal is to reduce disability and support recovery after ischemic stroke in adults aged 22 to 80 years. This multicenter study involves about 20 to 30 centers and compares active treatment to a sham device in a randomized, controlled design. The study has three stages: Stage 1 runs from 4 to 21 days after stroke onset to day 90, where participants receive either active or sham treatment five times per week, completing at least 45 sessions. Each session lasts about 60 minutes, with 40 minutes of stimulation combined with a home-based exercise program. In Stage 2, from day 90 to day 180, all participants who adhered to Stage 1 can continue active treatment up to five times weekly. Stage 3, from day 180 to day 270, involves no treatments but continued follow-up. Participants and caregivers receive training on device use and exercises, with support provided remotely or in person. Researchers assess outcomes at days 45, 90, 180, and 270 after stroke, focusing on changes in neurological disability using the Modified Rankin Scale. Safety is monitored throughout, and participation complements usual care without replacing it.

Researchers are evaluating GetUp&Go, a remotely delivered program designed to promote increased physical activity in adults who are at least six months post moderate-to-severe traumatic brain injury (TBI). This randomized controlled trial aims to see if the 10-week GetUp&Go program, which includes personalized activity planning and a mobile health app called RehaBot, can help participants increase physical activity and improve mental and physical health compared to those on a waitlist. The study also examines whether continued access to RehaBot supports maintaining physical activity gains and explores how individual characteristics affect response to the program. Participants will first undergo baseline testing and then be randomly assigned either to immediate GetUp&Go treatment or a waitlist for 10 weeks. After this initial phase, the waitlist group will receive the GetUp&Go program. Following completion of the intervention, all participants will be randomly assigned to either continue with RehaBot support without therapist contact or to no longer have access to RehaBot for another 10 weeks. Evaluations will be conducted after each phase, including the initial 10 weeks and the follow-up period. During the study, researchers will monitor physical activity using accelerometers to measure movement counts per minute at baseline, after the initial 10-week intervention, and after the follow-up period. They will also assess secondary outcomes such as self-reported physical activity, emotional function, fatigue, sleep quality, pain, and health-related quality of life. Safety will be overseen by study physicians, and participants will be evaluated for their ability to use mobile technology and communicate in English. The total study duration includes baseline, intervention, waitlist crossover, and follow-up assessments.

Researchers are evaluating the effectiveness of the Gloreha Sinfonia robotic exoskeleton for upper limb rehabilitation in adults who have upper limb weakness following a recent stroke. This international multicenter randomized controlled trial compares robotic-assisted therapy combined with conventional therapy to conventional therapy alone. The main goal is to see if robotic therapy improves voluntary motor control and coordination better than conventional therapy, using the Fugl-Meyer Assessment for the upper limb as the primary measure. The study also looks at muscle strength, range of motion, eye-hand coordination, manual dexterity, functional independence, patient satisfaction, and any adverse events. Participants will be randomly assigned to one of two groups. The Experimental Group receives 90 minutes per day of upper limb therapy, including 30 minutes with the robotic device and the rest conventional physical and occupational therapy, progressing through passive to active mobilization over five weeks. The Control Group receives 90 minutes per day of conventional physical and occupational therapy tailored to their clinical needs. Both groups follow individualized rehabilitation programs. The study includes a baseline evaluation, treatment period, post-treatment evaluation, and a 3-month follow-up. Throughout the study, clinical assessments occur at baseline, after treatment, and at 3 months follow-up, with some follow-ups done remotely. Researchers measure motor function using standardized scales and track changes in strength, coordination, dexterity, and independence in daily living. Patient data are securely collected and analyzed to compare outcomes between groups. The total study duration is about 36 months, including recruitment, treatment, and follow-up phases.

Researchers are evaluating the safety and effectiveness of the iovera system in people with spasticity affecting the muscles of the upper arm and elbow due to cerebral or spinal conditions. This randomized, double-blind study involves about 132 participants, with two-thirds receiving the iovera system treatment and one-third receiving a sham treatment. The goal is to compare muscle tone changes and monitor safety over 13 weeks. Participants will receive either ultrasound-guided treatment with the iovera system or a sham device, following local anesthetic injection. Target nerves treated include the medial and lateral pectoral nerves and the musculocutaneous nerve branches to certain arm muscles. Ultrasound and nerve stimulation techniques will be used to precisely locate nerves. Treatment and screening may occur on the same day or up to 30 days apart. During the 13-week follow-up, participants will be assessed at weeks 3, 7, and 13 for changes in muscle tone using the Modified Ashworth Scale and other scales evaluating spasticity and goal achievement. Safety and efficacy will be closely monitored through clinical assessments and participant evaluations. The primary outcome is the change in muscle tone from baseline to week 13 using the Modified Ashworth Scale for the elbow.

Researchers are evaluating whether adding telerehabilitation focused on arm movement to usual care improves arm function and reduces disability after stroke. The study targets patients who experienced a stroke 90 to 150 days prior and have arm weakness. This is a randomized, controlled, assessor-blind study comparing telerehabilitation plus usual care to usual care alone. The hypothesis is that those receiving telerehabilitation will show greater recovery of arm function. Participants are randomly assigned to one of two groups: one receives telerehabilitation plus usual care, while the other receives usual care only but will be offered telerehabilitation after the study ends. Telerehabilitation involves 70 minutes per day of arm-focused activities, including exercises, games, stroke education, and videoconferencing with therapists, for 6 days a week over 6 to 8 weeks. Usual care continues for all participants during the study period. The study lasts about 8 months and includes four in-person visits for assessments such as arm function tests and a brain MRI. Those in the telerehabilitation group complete 36 sessions of motor training exercises and education. Researchers measure changes in arm function using the Action Research Arm Test after 2 months. Safety and progress are monitored throughout, and participants in the usual care group can access telerehabilitation after the study concludes.

Researchers are evaluating the use of the Eksobionic Exoskeleton (Esko), a robotic device designed to provide high repetition and intense training, for people with Parkinson's disease (PWPD) who have difficulties with walking or balance. The study aims to assess the impact of this eight-week intervention on walking ability, balance, and quality of life. Up to 24 participants with idiopathic Parkinson's disease at various stages (Hoehn and Yahr stages 1-4) will take part in this research to help establish a foundation for future long-term treatments. Participants will receive physical therapy using the Ekso robotic device twice a week for eight weeks. Each session lasts 60 minutes and includes setup, three 15-minute exercise segments, and a wrap-up. The device assists walking by guiding leg movements along a programmed path, with assistance levels gradually reduced as participants improve. Therapists adjust support or resistance based on patient fatigue and progress, with the goal of encouraging self-generated movement by the final phase. Heart rate and perceived exertion are monitored during sessions to gauge intensity. Throughout the study, participants will undergo several assessments such as walking speed and endurance tests, balance and fall risk evaluations, strength measures, and quality of life questionnaires. Monitoring includes continuous heart rate tracking and participant feedback on exertion. The last medication dose time will be recorded during assessments. Safety is closely observed, and participants can withdraw at any time. The study anticipates minimal risks like fatigue or discomfort, with measures in place to manage these and protect participant confidentiality. The total participation period includes treatment and a 3-month follow-up evaluation.