29 NA-CONTROL STUDY PROTOCOL 2 4. History of brain surgery 5. Claustrophobia 6. Epilepsy Participant selection and enrolment Figure 3 provides a flow-chart of the recruitment, consent and other procedures of patients in the NA-CONTROL study. Identifying potential participants All patients with NA that are newly referred to the Muscle Center of the Radboudumc during the study inclusion period will be checked for eligibility (i.e. meeting inclusion criteria 1–5) by a member of the treatment team through evaluation of the referral information. Eligible patients are informed about the NA-CONTROL study and their eligibility by post. At least a week after this notification letter is sent, a member of the treatment team will contact the patient to ask for his/her consent to be contacted by the coordinating researcher. Patients who express interest and provide consent will receive the extensive trial information package by e-mail. Consenting participants The coordinating researcher will contact patients who consent 7–14 days after the extensive trial information has been sent. After providing further clarification if needed, the coordinating researcher will state the inclusion and exclusion criteria. If the patient meets the inclusion and exclusion criteria, the researcher will ask the patient for oral consent and the baseline measurement will be scheduled. Written informed consent will be obtained by the coordinating researcher at the research location. prior to the start of the baseline measurement. All participants will receive a copy of the signed informed consent form. The original signed informed consent forms will be kept at the study site. After written informed consent is obtained, the patient’s hand dominance will be determined using the Edinburgh Handedness Inventory (EHI) 46 and the patient will be screened for signs of depressive mood disorder using the Beck Depression Inventory-Fast Screen (see Inclusion criteria 6 and Exclusion criteria 8, respectively). Patients’ participation will be noted in their medical chart. As per national regulations, all participants’ general practitioners will be notified of their participation. Ineligible and non-recruited patients A patient’s decision to decline participation will in no way affect their treatment at the Radboudumc. This is clearly communicated to patients during all contacts. For patients who are not eligible, who express that they are not interested in participation or who do not meet all inclusion and exclusion criteria, the usual procedure is followed; they will be put on the regular waiting list for a consultation at our expert outpatient clinic. The content of the rehabilitation programme is the same for patients that participate in the trial as for those that receive the rehabilitation programme outside the study.
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