Motor Improvement in Neurological Conditions (MINC): Multiple Sclerosis Design and methods of a single-arm feasibility study

Introduction Multiple sclerosis (MS) is a chronic progressive neurological disease. There is ample evidence that exercise can be beneficial. The advancement of modern technology led to improvements in the way therapy can be offered and can make it more motivating, thereby increasing adherence. The primary objective of this two site single blinded randomized control trial (RCT) is to explore the feasibility of conducting a multicentre definite RCT trial with a neuroanimation intervention of high-dose practice in people with mild-to-moderate MS. The secondary objective is to collect data on the variability of outcome measures to inform sample size calculations for a RCT. The tertiary outcome is to assess if this intervention changes exercise behaviour. Methods and analysis This study is in preparation for a future definitive randomised control trial (RCT) where the efficacy compared to a dose matched control therapy will be assessed. The setting for this study is a research laboratory at Edith Cowan University (ECU) and a neurological service provider, Multiple Sclerosis Society of Western Australia (MSWA). This feasibility study will recruit people with MS who have mild to moderate disability. Subjects will participate in 24 session, 2 times a week, of 60 minutes time-on-task intense arm training, using an exergaming system. Participants will undergo a follow up within 3 days and at 6 months after the final study visit. Ethics and dissemination This study was approved by the local Ethics Committee of Edith Cowan University. Subjects will be included after signing informed consent. Study outcomes will be disseminated through presentations at scientific conferences and through peer-reviewed journals. Trial registration ACTRN12622000281796 Strengths and limitations of this study ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial ACTRN12620001064998 ### Funding Statement This study is supported by MSWA. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: This study was approved by the local Ethics Committee of Edith Cowan University. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present work are contained in the manuscript