588139-Lustenhouwer

37 NA-CONTROL STUDY PROTOCOL 2 inferior, trigonum spinae and angulus acromialis) 64 at three levels of anteflexion (0°, 90° and 120°). Marker locations will be captured with 3D-photography at the Radboudumc’s 3D-photography laboratory. Subsequent analyses will provide the position and orientation of the scapula relative to the thoracic reference coordinate system. Randomization and blinding Patients with NA will be randomly assigned to either the experimental intervention or to the usual care in a 1:1 ratio. Patients are randomized using a Good Clinical Practice (GCP)-compliant system (Castor Electronic Data Capture), which employs stratified, variable block randomization. To prevent uneven distribution of certain characteristics across groups, randomization will be stratified according to two factors: sex (male/female) and age (4 blocks: 18–30, 30–42, 42–54, > 54 years). Randomization will be performed on site (at the Donders Institute for Brain Cognition and Behaviour, Centre for Cognitive Neuroimaging) after the participant has completed the baseline measurement (see Table 1). Due to the project design, it is not possible to blind participants or the assessor. Participants will inevitably know whether they are receiving the rehabilitation program or usual care. The assessor cannot be blinded either, for multiple reasons: all assessments are performed by a single assessor; as the number of assessments differs across groups, the assessor will know which participant belongs to which group; as the rehabilitation program takes place at the assessor’s workplace facility, the assessor could be un-blinded on encountering a participant visiting the facility for treatment. Withdrawal procedures Participants can choose to withdraw their consent and leave the study at any time, without specifying the reason. No additional assessments will be obtained after a subject withdraws. Data that have been collected up until that point will be used for analyses. Participants have consented to this as part of the original informed consent. Patients that want to withdraw from the study can continue with the rehabilitation program outside the trial if they wish to do so. The investigator or a member of the treatment team can decide to withdraw a subject from the study for urgent medical reasons. Patients with NA who have a recurrent attack during their participation will be withdrawn from the study. If a patient is withdrawn from the study before their visit to the expert outpatient clinic, they are asked to come to the Rehabilitation or Neurology outpatient clinic for a single interdisciplinary visit, to confirm their diagnosis of NA and provide treatment advice as usual. Patient retention Patient retention is promoted in several ways. When participating in the specific rehabilitation program, the patient is in regular contact with the Radboudumc treatment team (i.e. first five weekly visits, followed by two biweekly visits and two monthly visits over a 17-week period). Patients in the usual care group will be contacted at least twice during the 17-week control treatment period. The coordinating researcher will contact them by phone to inquire how the patient is and to remind them of the dairy in which

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