跳至主要内容
临床试验/NCT06815809
NCT06815809招募中不适用

Floor-hugging Intervention: Managing Fear of Falling Through Floor Exposure and Developing After-fall Contingency

Karlstad University1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2025年2月11日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
48
试验地点
1
主要终点
Falls Efficacy Scale-International

研究概览

简要总结

Fear of falling is a major public health problem and is characterized by a lack of confidence in one's ability to maintain balance and prevent falls. The fear can range from reasonable precautions to avoid slippery surfaces to an overwhelming fear that prevents people from performing everyday activities. Several factors contribute to this fear, including physical, psychological, social and environmental factors. These factors can not only lead to an increased tendency to fall, but also to increased anxiety, depression and social isolation, which can ultimately impair the individual's physical and mental health. Current approaches to help have only limited or moderate success, often because they do not take into account how the environment affects people's relationship with the floor.

For example, in urbanized societies, people spend less time in contact with the floor, which may have led to an individual's perception of the floor changing. This connection is not only physical, but can also involve a lack of mental and sensory familiarity. Without regular interaction with the floor in different positions, the individual may feel insecure or unfamiliar with the floor. This unfamiliarity can increase anxiety and encourage hypervigilant behavior that can lead to a fear of falling. Similarly, unfamiliarity with the floor can also contribute to a person's ability to respond effectively to a fall, often leaving the person unsure of what steps to take next.

The Floor-Hugging Intervention (Floor-HI) is a new intervention that can address these issues. The intervention consists of three main parts: learning how to get down on the floor, familiarizing oneself with the floor, and learning how to get back up. In the first part, participants learn how to lie down on the floor using evidence-based methods. The participant then practices lying on the floor to become more comfortable and less anxious. By repeatedly practicing lying on the floor in a safe environment, the intervention aims to break the connection between the floor and the fear associated with it, while promoting a more positive and confident mindset.

The third part of Floor-HI is to teach strategies for getting up from the floor. This is important to help participants gain the confidence and physical strength to recover from falls. Participants are given practice in different ways to get up, first with the help of furniture and then without assistance. The training aims not only to improve participants' physical abilities but also their confidence in dealing with falls.

Each session of the Floor HI programme is designed to last 1 hour and to be performed three times a week for three weeks. The training would be divided equally between getting used to the floor and learning to stand up. The results of the programme would be evaluated by assessing its impact on participants' fear of falling, static and dynamic balance, fall frequency, ability to get up from the floor and general quality of life. In addition, the acceptability of the intervention and any adverse events occurring as a result of participation in the intervention will also be collected. In conclusion, Floor-HI can be a good way to manage the fear of falling by focusing on both mental and physical aspects, which can ultimately help people to live more active and fulfilling lives.

详细描述

Background Fear of falling (FoF) is a serious public health problem affecting healthy and patient populations worldwide. It can range from a healthy caution that leads individuals to avoid environmental hazards such as icy, slippery roads or wet surfaces, to a disabling fear that forces them to stay at home, limiting their mobility and participation in activities of daily living. Several factors contribute to the development of FoF, including physical, cognitive, psychological, social and environmental influences. For example, in older adults, age-related declines in strength, sensation and cognitive function increase the risk of falling, which ultimately increases the FoF. Similarly, environmental factors such as icy winter conditions, particularly in Scandinavia, have been shown to increase FoF, not only in older adults but also in middle-aged and younger populations. FoF leads to self-imposed avoidance behaviors, meaning that individuals suffering from FoF voluntarily restrict their own mobility, which further worsens their health outcomes, increases their social isolation and reduces their overall quality of life. Ironically, this avoidance behavior, which is intended to prevent falls, has been reported to increase the risk of falling.

Despite the availability of interventions to reduce FoF, their effectiveness remains limited. One possible explanation is the lack of focus on the design of the environment, particularly on how individuals interact with the floor itself. In urbanized societies, direct contact with the floor through activities such as sitting, lying down or kneeling is rare. This lack of engagement can create a sense of unfamiliarity, similar to the discomfort a European might feel when eating with chopsticks in Asia, or a Swedish driver navigating left-hand traffic in the UK. Both examples illustrate how unfamiliarity with a task can lead to psychological uncertainty. For individuals with limited exposure to floor-based activities, this disconnect may similarly exacerbate psychological uncertainty about the floor and managing falls, intensifying FoF. Likewise, reduced engagement with floor-based activities in urbanized societies might also lead to deconditioning of the muscular strength and coordination needed to recover from falls. This could explain why adults who are do not know how to get back up after a fall experience heightened FoF.

These explanations are consistent with the uncertainty and anticipation model, which suggests that uncertainty about potential threats - such as falling - can increase threat expectancy. This overestimation of the risks associated with falling may in turn lead to maladaptive behaviors, including hypervigilance, avoidance, biased attention and poor updating of associative learning, all of which may contribute to increased FoF (10). Addressing this multifaceted problem therefore requires interventions that address underlying causes, such as limited ground exposure and inadequate post-fall recovery strategies, to mitigate the development of FoF.

The Floor Hugging Intervention (Floor-HI) is one such program that has been developed along these lines and may prove to be a potentially beneficial approach to alleviating FoF. The program comprises two main components: one aimed at enhancing familiarity with the floor and the other focused on developing post-fall strategies. Here, the first component of the Floor-HI, which deals with floor exposure, is based on emotional processing theory and allows for confrontation with the uncertainty of the floor and falls by asking individuals to lie on the floor in various positions while imagining that they have fallen. The act of spending time on the floor and imagining a fall in a safe environment is intended to create cognitive dissonance that can reshape and update fear structures to reduce the FoF. The second component of Floor-HI, which involves teaching individuals' strategies for getting back up after a fall, is intended to further empower individuals by increasing their self-efficacy in coping with falls, thereby further reducing the uncertainty (i.e. lack of post-fall contingencies) that also contributes to the development of FoF.

An innovative feature of Floor-HI is the use of printed surfaces that simulate high-risk environments such as icy, snowy, wet and cluttered surfaces, allowing participants to train in environments that reflect real-world challenges. This environmentally relevant approach ensures that training remains ecologically salient, safe while preparing individuals for potential hazards in a controlled and engaging manner. The program also addresses a critical gap in current government guidelines, which focus primarily on ground level strategies that rely on furniture for support. Such strategies may not be applicable in outdoor or unsupported environments. Floor-HI takes a personalized approach, allowing participants to choose between supported and unsupported floor-rising techniques based on their physical abilities.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Participants must be healthy adults between the ages of 18 and
  • Participants must be fluent in either Swedish or English.
  • Participants must have a Montreal Cognitive Assessment (MoCA) score of 23 or higher.
  • Participants must be able to perform activities of daily living independently.

排除标准

  • Participants with neurological diseases (e.g., stroke, Parkinson's disease, multiple sclerosis, traumatic brain injury, etc.).
  • Participants with musculoskeletal disorders (e.g., rheumatoid arthritis, sprains, strains, etc.).
  • Participants with severe cognitive impairments (Montreal Cognitive Assessment score < 23).
  • Participants with psychiatric disorders (e.g., bipolar disorder, schizophrenia).
  • Participants currently involved in any other exercise-based interventions that involves prolonged floor contact (e.g., yoga, martial arts, dance).

结局指标

主要结局

Falls Efficacy Scale-International

时间窗: Evaluated at four time points: baseline (week 0), pre-intervention (week 3), post-intervention (week 6), and follow-up (week 9).

Fear of falling will be evaluated using the 16-item Falls Efficacy Scale-International. This scale measures fear of falling during daily activities, making it suitable for active adults. Additionally, it incorporates the social aspects of this fear and has demonstrated strong measurement properties, even across different cultural settings.

次要结局

  • Sitting rising test(Evaluated at four time points: baseline (week 0), pre-intervention (week 3), post-intervention (week 6), and follow-up (week 9).)
  • Mini-BESTest(Evaluated at four time points: baseline (week 0), pre-intervention (week 3), post-intervention (week 6), and follow-up (week 9).)
  • 360° Turn Test(Evaluated at four time points: baseline (week 0), pre-intervention (week 3), post-intervention (week 6), and follow-up (week 9).)
  • 36-item RAND Health Survey(Evaluated at four time points: baseline (week 0), pre-intervention (week 3), post-intervention (week 6), and follow-up (week 9).)
  • Fall incidence (Fall diary)(Self-recorded by participants everyday from week 0 (baseline) to week 9 (follow-up) i.e., 63 days)
  • Theoretical Framework of Acceptability questionnaire(Evaluated at two time points: pre-intervention (week 3) and post-intervention (week 6).)

研究者

发起方
Karlstad University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Shashank Ghai

Associate Senior Lecturer

Karlstad University

研究点 (1)

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