Intervention to Master Complex Fall Risk Situations in Persons With Multiple Sclerosis (STAR)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegion Örebro County
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Individual strategies
BehavioralThis arm will receive an individual analyses of current fall situations and a tailored individual strategy aiming to reduce fall frequency
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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 monthsSecondary outcomes
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
Time frame
baseline and immediately after the intervention2
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 intervention3
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 intervention4
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 interventionOther outcomes
1
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
baseline2
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
baseline3
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
baseline4
"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 interventionLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Region Örebro County
Lead sponsor
Institution of Medical Sciences, Örebro University
Collaborator
Region Gävleborg
Collaborator
Region Västmanland
Collaborator
Sormland County Council, Sweden
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: