NCT07378566

Intervention to Master Complex Fall Risk Situations in Persons With Multiple Sclerosis (STAR)

Digitally Supported Intervention to Master Complex Fall Risk Situations in Persons With Multiple Sclerosis - a Multicenter Study (STAR)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Region Örebro County · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

The intervention will be based on previous findings i. e., fall risk factors related to the International Classification of Functioning, Disability and Health and is an add-on intervention to a general fall risk information.

Conditions

• Multiple Sclerosis
• Fall

Interventions

Type	Name	Description
BEHAVIORAL	Individual strategies	This arm will receive an individual analyses of current fall situations and a tailored individual strategy aiming to reduce fall frequency

Timeline

• Start date: 2026-01-01
• Primary completion: 2028-07-31
• Completion: 2028-12-31
• First posted: 2026-01-30
• Last updated: 2026-01-30