96 CHAPTER 5 Design A single-centre, two-armed RCT (NA-CONTROL study) with repeated measurements was conducted at the Neuromuscular Center of the Radboud University Medical Center in Nijmegen, the Netherlands. The full study protocol and statistical analysis plan were published. 124 The study was approved by the local medical ethics committee (Medical Ethical Committee region Arnhem-Nijmegen, CMO 2017-3740) and was registered at ClinicalTrials.gov (NCT03441347) before the start. Written informed consent was obtained from all participants in this study. Participants Patients were recruited via the outpatient clinic of our Neuromuscular Center which hosts the outpatient Plexus Clinic, a national expert and European referral centre for patients with NA. Inclusion criteria were, diagnosed with NA6, 186 with presence of coordinative motor dysfunction (i.e. scapular dyskinesia), beyond the acute phase of NA (> 8 weeks after onset) and aged ≥ 18 years. Exclusion criteria were previous participation in MR, relevant comorbidities influencing rehabilitation, and in case of a recurrent NA episode during the study. 124 For full in- and exclusion criteria, selection and enrolment, see our design paper. 124 Randomization and blinding Participants were randomly (1:1 ratio) assigned to either the MR group or the UC group using a Good Clinical Practice (GCP)-compliant electronic data management system (Castor EDC) with stratified (sex (male/female) and age (18–30, 30–42, 42–54, > 54 years)) and variable (2-4-6) block randomization. After an initial period of 18 weeks receiving UC, the UC group also received the MR. Both groups were followed up for another 18 weeks after finishing the MR, for a total follow up of 36 weeks after start of MR (see Figure 1). Blinding was not possible due to the nature of the intervention (MR at the expert center versus UC) and self-report character of the primary outcome measure (SRQ-DLV). Outcomes The SRQ-DLV, our primary outcome, is a reliable and validated self-report questionnaire measuring functional capability of the shoulder, arm and hand. 34 It has shown to be sensitive to changes in patients with NA. 1 It consists of a visual analogue scale measuring the global assessment of wellbeing (very poor to very well) considering the complaints of the affected shoulder and 19 multiple choice items covering seven domains (pain, daily activities, recreational or athletic activities, work, satisfaction and areas for improvement). 187 The SRQ-DLV total score ranges from 17 to 100, with higher scores indicating better functioning (range 15-90 if no score in the work domain). A set of secondary outcomes was pre-specified to cover multiple domains (impairments, activities, participation and personal factors) of the International Classification of Functioning, disability and health (ICF) and are described below. 47 Impairments Arm muscle strength was measured with a MicroFET2®, digital manual muscle dynamometer, to determine maximal force exerted by the serratus anterior muscle, 75 and
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