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Completed

NCT Number: NCT03874728

The Effects of Minimal Shoes in Older People at Risk of Falls: The Feetback Shoe Study

A third of people over 65, and half of people over 80, fall at least once a year. Falls are the most common cause of death from injury in the over 65s and result in a significant financial burden on the whole society. Shoes directly influence balance, gait, and the subsequent risk of slips, trips and falls by altering somatosensory feedback to the foot and ankle. Minimal shoes, that is shoes lacking a firm heel cup, a rigid sole or longitudinal arch support, have shown advantages in strengthening muscles and improving balance as compared to conventional shoes. However, limited research has studied the effect of minimal shoe in older people at risk of falls. The aim of the project will be to assess the effects of minimal shoes in older people at risk of falls, compared to conventional shoes and barefoot.

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Key information

Conditions

Falls Aging

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Liverpool

Liverpool, Merseyside, L8 0TL, United Kingdom

About this study

Study participants will attend a one-day testing session at the Movement Laboratory, University of Liverpool. Participants will be subjected to several standing and walking tests while wearing three types of footwear in a randomised order: (i) a minimal shoe, (ii) a conventional shoe, and (iii) barefoot. Participants' physical function, stability during standing and walking and an activity of lower leg muscles will be assessed in each of those three footwear conditions. Participants will also be asked about perceptions of footwear, regarding a minimal shoe and a conventional shoe. At the end of assessments, participants will be asked to complete several walking bouts while wearing a minimal shoe with "smart" shoe insoles, to determine "smart" insoles' validity in obtaining gait characteristics against a gold standard measure. Finally, those participants who volunteer to take part in a two-week follow-up study, will be asked to wear the minimal shoes with "smart" insoles during daily life for two weeks, After two weeks, they will be asked to fill in an online questionnaire asking them about total time they used the minimal shoes and insoles and about how satisfied they were with them.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: ≥ 60 years old
  • One of the vulnerability criteria for risk falls:

(i) ≥ 1 self-reported falls after the age of 60; (ii) balance impairment as indicated by a score <45 on the Berg Balance Scale, by a score >2 on the simplified Tinetti Gait & Balance test or via any other validated and reliable clinical instrument used at the recruitment site; (iii) one or two criteria for physical frailty

Exclusion criteria

  • Macro-vascular symptoms (angina, stroke or a peripheral vascular disease)
  • Neuromuscular diseases (Multiple Sclerosis, Alzheimer Disease or Parkinson Disease)
  • Diabetes
  • Use of a walking aid (cane or walker)
  • Ankle, knee, hip surgery ≤ 3 months
  • Pain in the lower extremities of ≥ 8 on the numeric rating scale

Treatment and study plan

Minimal shoes

Other

A minimal shoe (Vivobarefoot Ltd., London, UK) will be used.

Standardised conventional shoes

Other

The Go Walk 4.0-Pursuit shoe for women (Skechers USA, Inc.) and the Superior 2.0-Jeveno shoe for men (Skechers USA, Inc) will be used.

Barefoot

Other

Participants will conduct the assessments barefoot.

"Smart" shoe insoles

Other

Arion pressure-measuring insoles (Eindhoven, The Netherlands) will be used in the study.

Primary outcomes

  1. Timed Up and Go test

    Time frame: First day of joining the study

    Time (in seconds) to complete the Timed Up and Go test

  2. Star Excursion Balance Test

    Time frame: First day of joining the study

    Reach (in centimetres) to achieve during the Star Excursion Balance Test

  3. Postural stability

    Time frame: First day of joining the study

    Anterior-Posterior and latero-medial movement (in centimetres) of the centre of pressure

  4. Dynamic stability

    Time frame: First day of joining the study

    Variability (standard deviations) of spatio-temporal gait characteristics

  5. Muscle activity

    Time frame: First day of joining the study

    Electromyography activity for selected lower leg muscles and expressed in millivolts

  6. Perceived attractiveness

    Time frame: First day of joining the study

    Scored on a 100-millimetres (mm) visual analogue scale with 0 mm being "extremely unattractive" and 100 mm being "extremely attractive"

  7. Perceived attractiveness for others

    Time frame: First day of joining the study

    Scored on a 100-millimetres (mm) visual analogue scale with 0 mm being "extremely unattractive for others" and 100 mm being "extremely attractive for others"

  8. Perceived comfort

    Time frame: First day of joining the study

    Scored on a 100-millimetres (mm) visual analogue scale with 0 mm being "extremely uncomfortable" and 100 mm being "extremely comfortable"

  9. Perceived weight

    Time frame: First day of joining the study

    Scored on a 100-millimetres (mm) visual analogue scale with 0 mm being "extremely light" and 100 mm being "extremely heavy"

  10. Perceived fit

    Time frame: First day of joining the study

    Scored on a 100-millimetres (mm) visual analogue scale with 0 mm being "poorest fit possible" and 100 mm being "best fit possible"

  11. Perceived ease of use

    Time frame: First day of joining the study

    Scored on a 100-millimetres (mm) visual analogue scale with 0 mm being "most difficult as possible" and 100 mm being "as easy as imaginable"

  12. Perceived stability

    Time frame: First day of joining the study

    Scored on a 100-millimetres (mm) visual analogue scale with 0 mm being "extremely unstable" and 100 mm being "extremely stable"

Secondary outcomes

  1. Validity of "smart" shoe insoles

    Time frame: First day of joining the study

    Validity of Arion insoles against Qualisys Motion Capture System

  2. Adherence to wearing minimal shoes in daily life

    Time frame: The assessment will be performed at 2 weeks

    Adherence to wearing minimal shoes with "smart" shoe insoles assessed with an online questionnaire and expressed in total time in days and hours

  3. Satisfaction of wearing minimal shoes in daily life

    Time frame: The assessment will be performed at 2 weeks

    Satisfaction of wearing minimal shoes with "smart" shoe insoles assessed with an online questionnaire and expressed on a 5-point Likert scale, with the following levels: 1 - Very dissatisfied, 2 - dissatisfied, 3 - unsure, 4 - satisfied, 5 - Very satisfied.

  4. Gait characteristics during daily life

    Time frame: The assessment will be performed at 2 weeks

    Gait characteristics, assessed with "smart" shoe insoles, during activities of daily life and expressed in spatio-temporal metrics

Sponsors and collaborators

Lead sponsor

University of Liverpool

Other

Collaborators

  • Liverpool University Hospitals NHS Foundation Trust

Registry information

Official study title

Preventing Falls in Older People Using an Innovative Connected Shoe: Development & Biomechanics Study.

Acronym: FSS

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 14, 2019
Registry last updated
Jul 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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