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

NCT07378566 | Not Yet Recruiting

• 1 other identifier: 285079
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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

Fall; Multiple Sclerosis

Keywords

falls; prevention

Outcome Measures

Primary Outcomes (1)

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

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

  every 14th day during 6 months

Secondary Outcomes (6)

• Falls-Efficacy Scale-International score

  baseline and immediately after the intervention

• Activity-specific balance Confidence Scale score

  baseline and immediately after the intervention

• Self-rated ability to reduce falls

  baseline and immediately after the intervention

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

  baseline and immediately after the intervention

• Self-rated fear of falling reducing activities

  baseline and immediately after the intervention

Other Outcomes (5)

• Timed Up and Go test

  baseline

• Six Spot Step Test

  baseline

• Symbol Digit Modalities Test

  baseline

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Behavioral: Individual strategies

Control group

NO INTERVENTION

This arm will only receive general advice. Will be offered the intervention after ending of the study period

Interventions

Individual strategies BEHAVIORAL

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

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Related Publications (8)

• 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.

  PMID: 35765037 RESULT

• 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.

  PMID: 25254633 RESULT

• 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.

  PMID: 24948687 RESULT

• 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.

  PMID: 23237970 RESULT

• 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.

  PMID: 28901164 RESULT

• 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.

  PMID: 19218300 RESULT

• 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.

  PMID: 23633067 RESULT

• 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.

  PMID: 39502367 RESULT

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Ylva E Nilsagård, Ass. prof

  University Healthcare Research Center, Faculty of Medicine and Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Statistician
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research leader Integrated care

Model Details: The study will be conducted in two phases starting with an internal pilot study followed by a full scale RCT

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: January 30, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 30, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Study protocol and Statistical Analysis plan before study start.
• Access Criteria: Open access if accepted for publication