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Multiple SclerosisSTARNCT07378566

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

A study testing Individual strategies in people with Multiple Sclerosis and Fall, run by Region Örebro County.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Sclerosis, Fall
What is being tested?
Individual strategies
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
No sites listed yet
Study dates
1 Jan 2026to 31 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Ylva E Nilsagård, Ass. prof contact

+46 070 609 37 37

ylva.nilsagard@regionorebrolan.se

Anna Wäneskog, PhD contact

+460 021-175972

anna.waneskog@regionvastmanland.se

About this study

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

Read the 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.

Being tested
Individual strategies
Keywords
falls, prevention
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Individual strategiesBehavioural

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

Study groups in NCT07378566
Study groupRoleWhat they receive
Intervention groupExperimentalThis arm will receive an individual analyses of current fall situations and a tailored individual strategy aiming to reduce fall frequency
Receives: Behavioral: Individual strategies
Control groupNo interventionThis arm will only receive general advice. Will be offered the intervention after ending of the study period

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: every 14th day during 6 months

Secondary outcomes (6)

  1. Falls-Efficacy Scale-International score

    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

    Measured: baseline and immediately after the intervention

  2. Activity-specific balance Confidence Scale score

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

    Measured: baseline and immediately after the intervention

  3. Self-rated ability to reduce falls

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

    Measured: baseline and immediately after the intervention

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

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

    Measured: baseline and immediately after the intervention

  5. Self-rated fear of falling reducing activities

    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)

    Measured: baseline and immediately after the intervention

  6. 12-item MS Walking scale score

    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

    Measured: baseline and immediately after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2026
  2. Study start1 Jan 2026 (estimated)
  3. Primary completion31 Jul 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study will be conducted in two phases starting with an internal pilot study followed by a full scale RCT
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07378566
Sponsor's protocol ID
285079
Acronym
STAR
Status last verified
Nov 2025
First submitted
3 Sep 2025
Last updated
30 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: We aim to publish a study protocol that includes a full description of the study

Publications

  • Salari N, Darvishi N, Ahmadipanah M, Shohaimi S, Mohammadi M. Global prevalence of falls in the older adults: a comprehensive systematic review and meta-analysis. J Orthop Surg Res. 2022 Jun 28;17(1):334. doi: 10.1186/s13018-022-03222-1.

    PubMed 35765037

  • Mazumder R, Murchison C, Bourdette D, Cameron M. Falls in people with multiple sclerosis compared with falls in healthy controls. PLoS One. 2014 Sep 25;9(9):e107620. doi: 10.1371/journal.pone.0107620. eCollection 2014.

    PubMed 25254633

  • Nilsagard Y, Gunn H, Freeman J, Hoang P, Lord S, Mazumder R, Cameron M. Falls in people with MS--an individual data meta-analysis from studies from Australia, Sweden, United Kingdom and the United States. Mult Scler. 2015 Jan;21(1):92-100. doi: 10.1177/1352458514538884. Epub 2014 Jun 16.

    PubMed 24948687

  • Gunn HJ, Newell P, Haas B, Marsden JF, Freeman JA. Identification of risk factors for falls in multiple sclerosis: a systematic review and meta-analysis. Phys Ther. 2013 Apr;93(4):504-13. doi: 10.2522/ptj.20120231. Epub 2012 Dec 13.

    PubMed 23237970

  • Carling A, Forsberg A, Nilsagard Y. Falls in people with multiple sclerosis: experiences of 115 fall situations. Clin Rehabil. 2018 Apr;32(4):526-535. doi: 10.1177/0269215517730597. Epub 2017 Sep 13.

    PubMed 28901164

  • Nilsagard Y, Lundholm C, Denison E, Gunnarsson LG. Predicting accidental falls in people with multiple sclerosis -- a longitudinal study. Clin Rehabil. 2009 Mar;23(3):259-69. doi: 10.1177/0269215508095087.

    PubMed 19218300

  • Gunn H, Creanor S, Haas B, Marsden J, Freeman J. Risk factors for falls in multiple sclerosis: an observational study. Mult Scler. 2013 Dec;19(14):1913-22. doi: 10.1177/1352458513488233. Epub 2013 Apr 30.

    PubMed 23633067

  • Waneskog AH, Forsberg AS, Nilsagard YE. Exploring the Complexity of Falls in People With Multiple Sclerosis: A Qualitative Study. Int J MS Care. 2024 Nov 5;26(Q4):308-314. doi: 10.7224/1537-2073.2024-020. eCollection 2024 Oct.

    PubMed 39502367

  • Nilsagard Y, Udumyan R, Halleberg Nyman M, Waneskog A. Individually designed fall prevention strategies compared to generic strategies for mastering complex fall risk situations in people with multiple sclerosis: study protocol of a randomised controlled trial. BMJ Open. 2026 Jul 15;16(7):e115430. doi: 10.1136/bmjopen-2025-115430.

    PubMed 42457429

Questions about this trial

What is this clinical trial studying?

A study testing Individual strategies in people with Multiple Sclerosis and Fall, run by Region Örebro County.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ylva E Nilsagård, Ass. prof (+46 070 609 37 37, ylva.nilsagard@regionorebrolan.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prospectively self-reported falls (rate, time to fall) (time frame: every 14th day during 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07378566, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.

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STAR Clinical Trial NCT07378566 | AzTrials