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

Abstract

AbstractIntroductionMultiple 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 analysisThis 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 disseminationThis 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 registrationACTRN12622000281796Strengths and limitations of this studyThe study intervention is a newly developed exercise intervention protocol designed to be engaging and motivatingNext to investigating primary efficacy in order to determine sample size for a larger trial, the study also uses implementation science to assess future obstacles in a follow up randomized control trialThe feasibility of conducting a larger trial will be based on standardised criteria regarding process, resource, and management metricsThis study without a control group demonstrates feasibility rather than efficacy