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

NCT07378566 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-01-30

No results posted yet for this study

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).

Conditions

Interventions

BEHAVIORAL

Individual strategies

This arm will receive an individual analyses of current fall situations and a tailored individual strategy aiming to reduce fall frequency

Sponsors & Collaborators

  • Institution of Medical Sciences, Örebro University

    collaborator UNKNOWN

  • Region Gävleborg

    collaborator OTHER

  • Region Västmanland

    collaborator OTHER

  • Sormland County Council, Sweden

    collaborator OTHER

  • Region Örebro County

    lead OTHER

Principal Investigators

  • Ylva E Nilsagård, Ass. prof · University Healthcare Research Center, Faculty of Medicine and Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2028-07-31
Completion
2028-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07378566 on ClinicalTrials.gov