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

Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Prospectively self-reported falls (rate, time to fall) [Срок оценки: every 14th day during 6 months]

Вторичные конечные точки (6)

• Falls-Efficacy Scale-International score [Срок оценки: baseline and immediately after the intervention]
• Activity-specific balance Confidence Scale score [Срок оценки: baseline and immediately after the intervention]
• Self-rated ability to reduce falls [Срок оценки: baseline and immediately after the intervention]
• Self-rated ability to understand one's own fall risk factors [Срок оценки: baseline and immediately after the intervention]
• Self-rated fear of falling reducing activities [Срок оценки: baseline and immediately after the intervention]
• 12-item MS Walking scale score [Срок оценки: baseline and immediately after the intervention]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07378566 · 285079

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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