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

NCT06815809 | Recruiting

• 1 other identifier: 2024-07271-01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fear of Falling; Balance Changes; Healthy

Keywords

Fear of falling; Balance assessment; After fall contingency

Outcome Measures

Primary Outcomes (1)

• Falls Efficacy Scale-International

  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.

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

Secondary Outcomes (6)

• 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

Other Outcomes (1)

• National Institute on Aging Adverse Event Form

  Evaluated during each training session i.e., nine training sessions during the course of three weeks

Study Arms (1)

Floor-HI intervention

EXPERIMENTAL

In the Floor-HI intervention arm the participants will undergo a 3-week training, where training is performed thrice a week during a 1-hour session. The training is conducted in three systematic steps mentioned as following: 1. Positioning on the floor: Participants assume a position on the floor, using the backward chaining method. 2. Floor hugging: Participants will assume a position on the floor, which may include supine, prone, side-lying, or semi-prone/supine poses. They will be encouraged to simulate a fall scenario by observing their surroundings while engaging in deep breathing exercises. 3. Getting back up from the floor: Participants will learn strategies to recover from a fall, tailored to their individual balance capabilities i.e., getting back up using supported furniture or without any support. The interventions are performed on printed surfaces that are attached to sports mat. These printed surfaces mimic high fall risk surfaces such as wet, icy, or snowy surfaces.

Behavioral: Floor-HI (intervention combines floor exposure with floor rise strategies)

Interventions

Floor-HI (intervention combines floor exposure with floor rise strategies) BEHAVIORAL

Floor HI training consists of the following three systematic steps 1. Positioning on the floor: Participants are first taught the backward chaining method. This technique involves using nearby furniture as support to move from an upright position to a kneeling position, through prone and side lying positions, and finally to a supine position. 2. Ground hugging: In this phase, participants will assume a position on the floor. They are encouraged to simulate a fall scenario by observing their surroundings while using relaxation techniques. This includes deep breathing exercises. 3. Getting up from the floor: The final phase focuses on teaching participants techniques to recover from a fall, tailored to their individual balance abilities. The intervention is carried out on printed surfaces that mimic high fall risk surfaces such as icy, cluttered, wet surfaces.

Floor-HI intervention

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must be healthy adults between the ages of 18 and 64.
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Karlstad University: lead

Study Sites (1)

RiskLab, Karlstad University

Karlstad, Värmland County, Sweden

RECRUITING

Related Publications (14)

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• Ohlsson-Nevo E, Hiyoshi A, Noren P, Moller M, Karlsson J. The Swedish RAND-36: psychometric characteristics and reference data from the Mid-Swed Health Survey. J Patient Rep Outcomes. 2021 Aug 4;5(1):66. doi: 10.1186/s41687-021-00331-z.

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• Potter K, Brandfass K. The Mini-Balance Evaluation Systems Test (Mini-BESTest). J Physiother. 2015 Oct;61(4):225. doi: 10.1016/j.jphys.2015.04.002. Epub 2015 Jun 1. No abstract available.

  PMID: 26044345 BACKGROUND

• Araujo CGS, Castro CLB, Franca JFC, Araujo DS. Sitting-rising test: Sex- and age-reference scores derived from 6141 adults. Eur J Prev Cardiol. 2020 May;27(8):888-890. doi: 10.1177/2047487319847004. Epub 2019 May 1. No abstract available.

  PMID: 31039614 BACKGROUND

• Halvarsson A, Stahle A. Psychometric properties of the Swedish version of the Falls Efficacy Scale-International for older adults with osteoporosis, self-reported balance deficits and fear of falling. Disabil Rehabil. 2018 Nov;40(22):2658-2661. doi: 10.1080/09638288.2017.1347210. Epub 2017 Jul 7.

  PMID: 28687055 BACKGROUND

• Leonhardt R, Becker C, Gross M, Mikolaizak AS. Impact of the backward chaining method on physical and psychological outcome measures in older adults at risk of falling: a systematic review. Aging Clin Exp Res. 2020 Jun;32(6):985-997. doi: 10.1007/s40520-019-01459-1. Epub 2020 Jan 14.

  PMID: 31939202 BACKGROUND

• Grupe DW, Nitschke JB. Uncertainty and anticipation in anxiety: an integrated neurobiological and psychological perspective. Nat Rev Neurosci. 2013 Jul;14(7):488-501. doi: 10.1038/nrn3524.

  PMID: 23783199 BACKGROUND

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  PMID: 34636923 BACKGROUND

• Lee D, Tak SH. A concept analysis of fear of falling in older adults: insights from qualitative research studies. BMC Geriatr. 2023 Oct 11;23(1):651. doi: 10.1186/s12877-023-04364-5.

  PMID: 37821830 BACKGROUND

• Bjornstig U, Bjornstig J, Dahlgren A. Slipping on ice and snow--elderly women and young men are typical victims. Accid Anal Prev. 1997 Mar;29(2):211-5. doi: 10.1016/s0001-4575(96)00074-7.

  PMID: 9088360 BACKGROUND

• Tinetti ME, Mendes de Leon CF, Doucette JT, Baker DI. Fear of falling and fall-related efficacy in relationship to functioning among community-living elders. J Gerontol. 1994 May;49(3):M140-7. doi: 10.1093/geronj/49.3.m140.

  PMID: 8169336 BACKGROUND

• Xiong W, Wang D, Ren W, Liu X, Wen R, Luo Y. The global prevalence of and risk factors for fear of falling among older adults: a systematic review and meta-analysis. BMC Geriatr. 2024 Apr 5;24(1):321. doi: 10.1186/s12877-024-04882-w.

  PMID: 38580924 BACKGROUND

• Ghai S, Ghai I. Floor-hugging Intervention: A Perspective on Floor Exposure and After-Fall Contingency Intervention. Adv Rehabil Sci Pract. 2024 Aug 22;13:27536351241271548. doi: 10.1177/27536351241271548. eCollection 2024 Jan-Dec.

  PMID: 39184216 BACKGROUND

Central Study Contacts

Shashank Ghai, Doctorate in Philosophy

CONTACT

46 070 290 4119; shashank.ghai@kau.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Senior Lecturer

Model Details: This study will use a sequential design with multiple pre- and post-assessments. Participants will be evaluated at four time points: baseline (week 0), pre-intervention (week 3), post-intervention (week 6), and follow-up (week 9).

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 7, 2025
• Study Start: February 11, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: February 14, 2025

Record last verified: 2025-02

Locations

SE (1)