Digitally Supported Intervention to Master Complex Fall Risk Situations in Persons With Multiple Sclerosis - a Multicenter Study (STAR)
Phase: NA
Conditions: Multiple Sclerosis, Fall
Sponsor: Region Örebro County

Study protocol & Statistical analyses plan 
Official title: Digitally Supported Intervention to Master Complex Fall Risk 
Situations in Persons with Multiple Sclerosis – a Multicenter Study (STAR) 
Brief title: Intervention to Master Complex Fall Risk Situations in Persons 
with Multiple Sclerosis (STAR)  
Protocol date: 2025-12-0812-08 ID 285079 
 
Background Fifty-six percent of those with a mild to moderate multiple sclerosis (MS) report 
falls during a three-month period and 60 % express fear of falling. Several fall risk factors have 
been identified a complexity of falls including the interaction of triggering factors and 
preceding activities and events has been described. There is a lack of studies explicitly 
evaluating fall prevention strategies given as counselling over time.  
Methods This is a two-armed internal pilot study with a parallel group design and random 
allocation to control or intervention group (1:1). The pilot study will evaluate feasibility in 
terms of recruitment, drop-outs, adverse events and battery of tests, and constitute the base for 
recalculation of the beforehand estimated sample size for a full-scale study. The full-scale study 
will evaluate whether a fall preventative strategy based on individual fall risk evaluation will 
reduce fall frequency compared to general fall preventative information. The hypothesis is that 
the intervention group will report 30% less falls during the 6-months period when the 
intervention is active, compared to the control group. Based on descriptions of recent fall 
situations, fall risk factors will be categorized using the International Classification of 
Functioning, Disability and Health. Participants in the intervention group will discuss the 
impact from specific MS-symptoms, environmental and personal factors, triggering factors and 
activities and/ or circumstances that the individual perceive precede fall situations with the 
physiotherapist leading to individual strategies. 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.  
Adults diagnosed with MS, fall history and remained walking ability will be recruited in six 
sites in Sweden by physiotherapists. Primary outcome is self-reported falls during six months. 
Secondary outcomes are self-rating scales focusing on concern of falling, confidence in 
remaining balance during activities, walking limitations and ability to avoid falls. 

 
Statistical methods  
The flow of participants through the study will be examined and illustrated according to the 
Consolidation Standard of Reporting Trials (CONSORT) (1). We will calculate the proportion 
of participants lost to follow-up.  

Analyses will be performed on an intention-to-treat basis. Baseline demographic and clinical 
characteristics of the study participants will be summarized for the two intervention groups 
separately. Continuous variables will be summarized using the measures of central tendency 
and dispersion (mean and standard deviation, the median and interquartile range as well as 
minimum and maximum values) as appropriate based on the distribution. Categorical variables 
will be summarized using frequencies and percentages. Since baseline characteristics are 
expected to be balanced between intervention groups due to randomization, we will evaluate if 
any substantial imbalance may have occurred by chance. 
The distribution of outcome data will be examined. For the analysis of primary outcome, we 
will consider Poisson regression if the assumptions are satisfied or Negative binomial 
regression, which relaxes the assumption made by Poisson regression that the variance is equal 
to the mean. We may consider also Cox regression to compare time to the first fall between 
intervention arms. Since falls may occur repeatedly in patients with MS, we may consider also 
extensions of Cox proportional hazards regression that are for recurrent event analyses. 
Estimates unadjusted and adjusted for baseline covariates will be presented. Secondary 
outcomes will be analyzed according to the measurement type and distribution.