Fall, Multiple Sclerosis
Conditions
Keywords
falls, prevention
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).
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.
Interventions
BEHAVIORALIndividual strategies
This arm will receive an individual analyses of current fall situations and a tailored individual strategy aiming to reduce fall frequency
Sponsors
Region Örebro County
Institution of Medical Sciences, Örebro University
Region Gävleborg
Region Västmanland
Sormland County Council, Sweden
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Statistician
Intervention model description
The study will be conducted in two phases starting with an internal pilot study followed by a full scale RCT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prospectively self-reported falls (rate, time to fall) | every 14th day during 6 months | Self-reported falls collected every two weeks during a 6-month period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Falls-Efficacy Scale-International score | 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 |
| Activity-specific balance Confidence Scale score | 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) |
| Self-rated ability to reduce falls | baseline and immediately after the intervention | One question measured using a visual analogue scale 0 (no ability) to 100 (full ability) |
| Self-rated ability to understand one's own fall risk factors | baseline and immediately after the intervention | One question using a visual analogue scale 0 (no understanding) to 100 (full understanding) |
| Self-rated fear of falling reducing activities | 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) |
| 12-item MS Walking scale score | 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 |
Contacts
CONTACTYlva E Nilsagård, Ass. prof
CONTACTAnna Wäneskog, PhD
PRINCIPAL_INVESTIGATORYlva E Nilsagård, Ass. prof
University Healthcare Research Center, Faculty of Medicine and Health
Outcome results
None listed