Wijk Aan Zee

Every year, about 40,000 people in the Netherlands experience a stroke, and many survivors face challenges with upper limb function, which is important for daily activities. This trial evaluates the effectiveness and cost-effectiveness of continuous theta burst stimulation (cTBS) treatment to improve upper limb recovery in stroke patients admitted to rehabilitation centers. This phase III, multi-center, double-blind, randomized, and sham-controlled clinical trial aims to build on promising phase II results showing significant improvement in arm function and reduced rehabilitation stay. Participants will receive either 10 daily sessions of active cTBS or sham cTBS delivered to the contralesional primary motor cortex within 3 weeks after stroke onset. These sessions are administered over 2 weeks and are given immediately before the patients' regular physical therapy for the affected upper limb. Two groups will be compared: one receiving active cTBS and the other receiving sham cTBS. During the study, researchers will assess upper limb recovery using the Fugl-Meyer Assessment at 90 days post-stroke as the primary outcome. Additional outcomes include arm function tests, stroke impact measures, quality of life, and disability scales at 90 days and one year after stroke. Participants will be closely monitored throughout the study to track their progress and safety, with total participation lasting up to one year after stroke.

Researchers are evaluating the effectiveness and cost-effectiveness of microprocessor-controlled knees (MPKs) compared to conventional mechanical knees (CMKs) in adults with lower limb amputation. The study focuses on walking distance as the primary outcome, along with other aspects of body function, activity, and participation. This observational study takes place within the standard healthcare system in the Netherlands and aims to provide a comprehensive understanding of how these prosthetic knees impact users' daily lives. Participants will first be assessed using their own conventional mechanical knee. Then, they will receive a microprocessor-controlled knee and undergo a six-week trial, including twice-weekly 30-minute physical therapy sessions. After the trial, participants switch back to their conventional knee for four weeks before repeating performance tests. Those who received the MPK will have a final follow-up assessment nine months later. This design allows comparison at multiple time points: baseline, after the trial, after returning to the original knee, and long-term follow-up. During four visits over one year, participants perform physical tests such as the 6-minute walking test and Timed Up and Go test. They also complete questionnaires on cost, balance confidence, rehabilitation participation, physical activity, and prosthesis evaluation. Additionally, participants wear an activity monitor for seven consecutive days to track real-life movement. These comprehensive assessments help researchers measure walking ability, prosthesis use, and quality of life while monitoring safety and long-term outcomes.