Individually Designed Fall Prevention Strategies Compared To Generic Strategies For Mastering Complex Fall Risk Situations In People With Multiple Sclerosis: Study Protocol Of A Randomised Controlled Trial

Introduction

Of individuals with mild-to-moderate multiple sclerosis (MS), 56% report falling at least once during a 3-month period. Several fall risk factors have been identified, but the issue is complex, with interactions between triggering factors and preceding activities and events. There is a lack of studies explicitly evaluating fall prevention strategies given as counselling over time.

The project includes (1) a two-armed randomised controlled internal pilot study with a nested qualitative study on participants’ experiences and (2) a randomised controlled trial (RCT). The pilot study will evaluate feasibility in terms of recruitment, dropout, adverse events and battery of tests and will constitute a basis for recalculating the preliminary estimated sample size for a full-scale study. The RCT study will evaluate whether fall prevention strategies based on individual fall risk evaluation reduce fall frequency compared with general fall prevention information. Participants in the intervention group will have an extensive discussion with a physiotherapist regarding the impact of specific MS symptoms, environmental and personal factors, triggering factors and activities and/or circumstances that they perceive to precede fall situations; these discussions will then lead to the creation of individual strategies. In case of falling during follow-up, further discussions on strategies will be held by phone contact. The control group will receive general fall risk prevention recommendations. After completion of the study, the control group will be offered individual strategies based on reported falls. Participants in the pilot study allocated to the intervention group will after follow-up be invited to individual interviews focusing on experiences of taking part in the intervention and the study.

Adults diagnosed with MS, fall history and remaining walking ability will be recruited by physiotherapists from six sites in Sweden. The primary outcome will be self-reported falls for 6 months and secondary outcomes will be self-rating scales covering concern about falling, confidence in remaining balance during activities, walking limitations and ability to avoid falls. Descriptive measures of disease impact will be used.

The study was approved by the Swedish Ethical Review Authority, Stockholm Dept. 4 (ID: 2025-04486-1, date: 2025-08-12). All participants will provide written informed consent. Findings will be disseminated through peer-reviewed journals, conference presentations and relevant patient organisations.

NCT07378566.