An interventional study of Individual strategies in Multiple Sclerosis and Fall, sponsored by Region Örebro County. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-30.
Sponsored by Region Örebro County · Not applicable, Interventional, and Treatment
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).
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.
Exclusion Criteria:
This arm will receive an individual analyses of current fall situations and a tailored individual strategy aiming to reduce fall frequency
Behavioral: Individual strategies
This arm will only receive general advice. Will be offered the intervention after ending of the study period
This arm will receive an individual analyses of current fall situations and a tailored individual strategy aiming to reduce fall frequency
Prospectively self-reported falls (rate, time to fall)
Self-reported falls collected every two weeks during a 6-month period
Time frame: every 14th day during 6 months
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
Time frame: baseline and immediately after the intervention
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)
Time frame: baseline and immediately after the intervention
Self-rated ability to reduce falls
One question measured using a visual analogue scale 0 (no ability) to 100 (full ability)
Time frame: baseline and immediately after the intervention
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)
Time frame: baseline and immediately after the intervention
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)
Time frame: baseline and immediately after the intervention
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
Time frame: baseline and immediately after the intervention
Timed Up and Go test
Measures basic mobility (time for rising up from a chair, walk 3m, turn around, walk back and sit down.
Time frame: baseline
Six Spot Step Test
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.
Time frame: baseline
Symbol Digit Modalities Test
Screening test for cognitive function pairing geometric figures with 10 numbers. Number of right and wrong answers given during 90 seconds
Time frame: baseline
"Frändin Grimby" activity scale
Measures physical activity the past 6 months using six alternatives ranging from hardly no physical activity to very hard physical activity
Time frame: baseline and immediately after the intervention
MS Impact Scale-29
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.
Time frame: baseline
No study locations are listed for this record.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — We aim to publish a study protocol that includes a full description of the study
Supporting information: Study protocol, Sap
This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Region Örebro County