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临床试验/NCT07378566
NCT07378566尚未招募不适用

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

Region Örebro County0 个研究点目标入组 80 人开始时间: 2026年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
80
主要终点
Prospectively self-reported falls (rate, time to fall)

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

Statistician

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Intervention group

Experimental

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

干预措施: Individual strategies (Behavioral)

Control group

No Intervention

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

结局指标

主要结局

Prospectively self-reported falls (rate, time to fall)

时间窗: every 14th day during 6 months

Self-reported falls collected every two weeks during a 6-month period

次要结局

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

研究者

发起方
Region Örebro County
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ylva Nilsagard

Research leader Integrated care

Region Örebro County

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