Journal of Clinical Trials

Journal of Clinical Trials
Open Access

ISSN: 2167-0870

+44 1478 350008


Innovative Physiotherapy and Continuity of Care in People with Multiple Sclerosis: A Randomized Controlled Trial and a Qualitative Study

Britt Normann, Paolo Zanaboni, Ellen Christin Arntzen and Gunn Kristin Øberg

Background: Individuals with Multiple Sclerosis (MS) frequently present balance and walking problems; in which reduced trunk stability, often termed core stability, is one essential aspect. A new group-based, individualized core stability training (GroupCoreSIT) is developed and will be evaluated in terms of effects, users’ perceptions, performance and coordination of care. Methods: The study consists of two related parts: 1) a prospective randomized controlled trial (RCT), and 2) a qualitative study. The RCT will be conducted in six municipalities to evaluate the effects of GroupCoreSIT on people with MS compared to standard care. The intervention addresses movement quality in core and balance training highlighting the following elements: dynamic stability, sensory stimulation, specificity, individualization, intensity, and teaching. GroupCoreSIT will be offered three hours per week for 6 weeks, complemented with unsupervised home exercises, with a 6-month follow-up. Seventy-to ambulant people with MS will be included, baseline tested and randomized to intervention and control group. Assessor blinded standardized outcome measurements will be carried at 1-week, 3-month and 6-month post-intervention. The qualitative study will include: i) qualitative interviews conducted twice with 12 participants from each group, at 1-week and 6-month post intervention, aimed to increase the knowledge about short and long-term experiences with GroupCoreSIT and standard care; ii) 12 observations and 12 qualitative interviews with physiotherapists conducting GroupCoreSIT, aimed to identify essential aspects of physiotherapy performance and perceptions related to delivery of intervention; and iii) qualitative interviews conducted twice with 16-20 health professionals in hospital and municipalities, focusing on intensive programs in the coordination of care for people with MS. Conclusion: Evaluation of the efficacy of GroupCoreSIT, participants’ perceptions, physiotherapists’ performance and reflections, and health professionals’ deliberations regarding coordination of intensive programs will provide information for evidence based selection of physiotherapy in ambulatory people with MS.