Intervention to Master Complex Fall Risk Situations in Persons With Mu
Digitally Supported Intervention to Master Complex Fall Risk Situations in Persons With Multiple Sclerosis - a Multicenter Study (STAR)
What it found
No result yet.
What was tested
Treatment tested
- Individual strategies
What it measured
Main measures
Prospectively self-reported falls (rate, time to fall)
every 14th day during 6 months
Walking and mobility
Other measures (6)
Falls-Efficacy Scale-International score
baseline and immediately after the intervention
Walking and mobilityActivity-specific balance Confidence Scale score
baseline and immediately after the intervention
Walking and mobilitySelf-rated ability to reduce falls
baseline and immediately after the intervention
Walking and mobilitySelf-rated ability to understand one's own fall risk factors
baseline and immediately after the intervention
Walking and mobilitySelf-rated fear of falling reducing activities
baseline and immediately after the intervention
12-item MS Walking scale score
baseline and immediately after the intervention
Walking and mobility
Who could take part
MS (type not specified) · 18 and over
Show the full criteria
Inclusion criteria
* Diagnosed with MS * Affected ability to walk du to MS according to the participant * At least one self-reported fall the last 3 months due to MS according to the participant
Exclusion criteria
* Unable to walk 100m even with walking device and/or pauses. * Apparently affected walking ability due to other conditions such as for example orthopedic or other neurological diseases. * Difficulty to answer questionnaires written in Swedish
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
People with multiple sclerosis (MS) have a higher fall risk compared to older people and to the general population. A meta-analysis reported that 56% of those with mild to moderate MS, fell at least once during a 3-month period. The risk of falling seems to peak when the walking distance starts to be affected and when walking aids are introduced and the walking distance is as short as 100 m. Previous studies have identified a number of fall risk factors, both relating to MS- symptoms and contextual factors. In a study published in 2025, we reported the complexity of fallsituations and the interaction between triggering factors, contextual factors and activities and circumstances that occurred before the fall incidents . The symptoms when having MS varies between individuals as well as over time. I the planned randomised, controlled multicenter study we move forward, producing individual fallrisk analyses based upon the findings from the study published in 2025, and offer individual strategies. This has not been studied before. All participants will receive general information on how fall risk can be prevented. Those randomised to control group will be offered the intervention after ending of the study. The study will be conducted in two phases starting with an internal pilot study followed by a full scale randomized controlled trial (RCT).
Papers
Results
Salari N, Darvishi N, Ahmadipanah M, Shohaimi S, Mohammadi M. Global prevalence of falls in the older adults: a comprehensive systematic review and meta-analysis. J Orthop Surg Res. 2022 Jun 28;17(1):334. doi: 10.1186/s13018-022-03222-1.Results
Mazumder R, Murchison C, Bourdette D, Cameron M. Falls in people with multiple sclerosis compared with falls in healthy controls. PLoS One. 2014 Sep 25;9(9):e107620. doi: 10.1371/journal.pone.0107620. eCollection 2014.Results
Nilsagard Y, Gunn H, Freeman J, Hoang P, Lord S, Mazumder R, Cameron M. Falls in people with MS--an individual data meta-analysis from studies from Australia, Sweden, United Kingdom and the United States. Mult Scler. 2015 Jan;21(1):92-100. doi: 10.1177/1352458514538884. Epub 2014 Jun 16.Results
Gunn HJ, Newell P, Haas B, Marsden JF, Freeman JA. Identification of risk factors for falls in multiple sclerosis: a systematic review and meta-analysis. Phys Ther. 2013 Apr;93(4):504-13. doi: 10.2522/ptj.20120231. Epub 2012 Dec 13.Results
Carling A, Forsberg A, Nilsagard Y. Falls in people with multiple sclerosis: experiences of 115 fall situations. Clin Rehabil. 2018 Apr;32(4):526-535. doi: 10.1177/0269215517730597. Epub 2017 Sep 13.Results
Nilsagard Y, Lundholm C, Denison E, Gunnarsson LG. Predicting accidental falls in people with multiple sclerosis -- a longitudinal study. Clin Rehabil. 2009 Mar;23(3):259-69. doi: 10.1177/0269215508095087.Results
Gunn H, Creanor S, Haas B, Marsden J, Freeman J. Risk factors for falls in multiple sclerosis: an observational study. Mult Scler. 2013 Dec;19(14):1913-22. doi: 10.1177/1352458513488233. Epub 2013 Apr 30.Results
Waneskog AH, Forsberg AS, Nilsagard YE. Exploring the Complexity of Falls in People With Multiple Sclerosis: A Qualitative Study. Int J MS Care. 2024 Nov 5;26(Q4):308-314. doi: 10.7224/1537-2073.2024-020. eCollection 2024 Oct.Results
Nilsagard Y, Udumyan R, Halleberg Nyman M, Waneskog A. 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. BMJ Open. 2026 Jul 15;16(7):e115430. doi: 10.1136/bmjopen-2025-115430.
Loading reviews and guidelines…
History
Started
Jan 2026
Main results due
Jul 2028
Finished
Dec 2028