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

Not yet recruitingNot a drug-phase studyMS (type not specified)NCT07378566

What it found

Still running

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 mobility
  • Activity-specific balance Confidence Scale score

    baseline and immediately after the intervention

    Walking and mobility
  • Self-rated ability to reduce falls

    baseline and immediately after the intervention

    Walking and mobility
  • Self-rated ability to understand one's own fall risk factors

    baseline and immediately after the intervention

    Walking and mobility
  • Self-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 registry

About 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

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History

    1. Started

      Jan 2026

    2. Main results due

      Jul 2028

    3. Finished

      Dec 2028

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