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NCT07378566Not yet recruiting

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)

Source: ClinicalTrials.gov · Last updated 30 Jan 2026

Brief summary (registry, in English)

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).

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
80 (estimated)
First submitted
3 Sept 2025
Start date
1 Jan 2026
Primary completion date
31 Jul 2028
Lead sponsor
Region Örebro County
NCT number
NCT07378566

What you commit to

  • Study type: Interventional
  • Planned participants: 80
  • From 1 Jan 2026 to the primary completion date, 31 Jul 2028
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Apparently affected walking ability due to other conditions such as for example orthopedic or other neurological diseases.

Other

  • Unable to walk 100m even with walking device and/or pauses.
  • Difficulty to answer questionnaires written in Swedish

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.