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NCT Number: NCT07378566

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

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).

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Fall Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Individual strategies

Behavioral

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

Primary outcomes

  1. Prospectively self-reported falls (rate, time to fall)

    Time frame: every 14th day during 6 months

    Self-reported falls collected every two weeks during a 6-month period

Secondary outcomes

  1. Falls-Efficacy Scale-International score

    Time frame: baseline and immediately after the intervention

    16 questions regarding level of concern about falling. Scores for each item together adds up to a total that ranges as follows: 16 (no concerns about falling( to 28 (severe concern about falling

  2. Activity-specific balance Confidence Scale score

    Time frame: baseline and immediately after the intervention

    16 questions regarding confidence to remain balance during everyday activities scoring from 0 (no confidence) to 100 (full confidence)

  3. Self-rated ability to reduce falls

    Time frame: baseline and immediately after the intervention

    One question measured using a visual analogue scale 0 (no ability) to 100 (full ability)

  4. Self-rated ability to understand one's own fall risk factors

    Time frame: baseline and immediately after the intervention

    One question using a visual analogue scale 0 (no understanding) to 100 (full understanding)

  5. Self-rated fear of falling reducing activities

    Time frame: baseline and immediately after the intervention

    One question where the person rates whether fear of falling have made them do less activities compared to before (yes, no, don't know, prefer not to answer)

  6. 12-item MS Walking scale score

    Time frame: baseline and immediately after the intervention

    Measures self-rated affected walking ability due to MS using 12 items. A score is obtained by subtracting the minimum score possible (=12) from the achieved sum, dividing by the range (=48) and multiplying by 100. Higher scores indicate more limited walking ability

Other outcomes

  1. Timed Up and Go test

    Time frame: baseline

    Measures basic mobility (time for rising up from a chair, walk 3m, turn around, walk back and sit down.

  2. Six Spot Step Test

    Time frame: baseline

    Measures speed, coordination and balance using time for a person to walk in zic-zac, kicking bricks using one foot for round one and the other foot for round two.

  3. Symbol Digit Modalities Test

    Time frame: baseline

    Screening test for cognitive function pairing geometric figures with 10 numbers. Number of right and wrong answers given during 90 seconds

  4. "Frändin Grimby" activity scale

    Time frame: baseline and immediately after the intervention

    Measures physical activity the past 6 months using six alternatives ranging from hardly no physical activity to very hard physical activity

  5. MS Impact Scale-29

    Time frame: baseline

    Measures self-rated physical and psychological MS-specific outcomes the past two weeks ranging from not at all to extremely. summing responses for its 20-item Physical Scale and 9-item Psychological Scale. The raw scores are transformed to a 0-100 scale, where higher scores indicate greater impact from the disease. The transformation for the Physical Scale is (100*(observed score - 20)) / (100-20), and for the Psychological Scale is (100*(observed score - 9)) / (45-9). A responder specific mean score can be calculated from completed items if at least 50% of the items in a scale are answered.

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Wäneskog, PhD

CONTACT

[email protected]

+460 021-175972

Ylva E Nilsagård, Ass. prof

CONTACT

[email protected]

+46 070 609 37 37

Sponsors and collaborators

Lead sponsor

Region Örebro County

Other

Collaborators

  • Institution of Medical Sciences, Örebro University
  • Region Gävleborg
  • Region Västmanland
  • Sormland County Council, Sweden

Registry information

Official study title

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

Acronym: STAR

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 30, 2026
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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