588139-Lustenhouwer

25 NA-CONTROL STUDY PROTOCOL 2 Taken together, the available evidence strongly suggests that maladaptive motor planning plays a role in long-term symptoms and disability in NA. Indirect evidence includes the presence of persistent scapular dyskinesia despite peripheral nerve recovery and muscle strength, and the fact that rehabilitation focused on relearning motor control can normalise scapular movements and positioning. However, at this time, there is no direct evidence for (mal)adaptive cerebral neuroplasticity in NA. Despite the high incidence of NA (1/1000 a year) 3 and the presence of debilitating residual complaints, 8 there are no randomised controlled trials (RCTs) investigating rehabilitation therapies targeting the residual complaints in NA. The NA-CONTROL study is an RCT designed to fill this gap; it compares the effect of a rehabilitation programme specifically designed for the residual complaints in this disorder to usual care in patients with NA. Additionally, the trial will combine clinical measures with measures derived to assess motor planning and representations in the central motor system, to provide mechanistic insights into how the rehabilitation program could change central motor system plasticity. Objectives Primary objectives The primary objective of this study is to determine the effect of a specific rehabilitation programme that combines relearning of motor control by targeting cerebral mechanisms with strategies to improve self-management, on functional capability of the upper extremity compared to usual care in patients with NA. Secondary objectives The secondary objectives of this study are: • To evaluate whether this rehabilitation program results in improvements in a range of domains, including but not limited to scapular dyskinesia, participation, quality of life and personal factors such as pain and fatigue, compared to usual care in patients with NA. • To assess the longer term (17 weeks post treatment) effects of the rehabilitation program on a variety of outcomes, including but not limited to functional capability of the upper extremity, participation, quality of life and personal factors such as pain and fatigue. • To determine the effect of this rehabilitation program on cortical motor planning and representations compared to usual care in patients with NA. Methods Study description The NA-CONTROL study is the first RCT to investigate treatment for residual complaints in neuralgic amyotrophy. It additionally investigates a relatively unexplored concept (i.e. the role of (mal)adaptive cerebral neuroplasticity in a disorder of the peripheral nervous system) and employs techniques (including functional magnetic resonance imaging (fMRI)) that have not yet been used to study the underlying cerebral mechanisms in NA. This study is conducted at the Donders Institute for Brain Cognition and Behaviour and the departments of Rehabilitation and Neurology of the Radboudumc in Nijmegen, the

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