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

Region Örebro County

Status: Not yet enrolling

Conditions: Multiple Sclerosis; Fall

Treatments: Behavioral: Individual strategies

Study type: Interventional

Funder types: Other

Identifiers

NCT07378566

285079

Details and patient eligibility

About

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).

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

80 participants in 2 patient groups

Intervention group

Experimental group

Description:

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

Treatment:

Behavioral: Individual strategies

Control group

No Intervention group

Description:

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