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

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

Study Overview

• Status: Completed
• Conditions: Aging; Falls
• Intervention / Treatment: Other: Minimal shoes; Other: Standardised conventional shoes; Other: Barefoot; Other: "Smart" shoe insoles

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United Kingdom
  • Merseyside
    • Liverpool, Merseyside, United Kingdom, L8 0TL
      • University of Liverpool

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Community-dwelling older adults

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Older people at risk of falls

Other: Minimal shoes; A minimal shoe (Vivobarefoot Ltd., London, UK) will be used.; Other: Standardised conventional shoes; 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.; Other: Barefoot; Participants will conduct the assessments barefoot.; Other: "Smart" shoe insoles; Arion pressure-measuring insoles (Eindhoven, The Netherlands) will be used in the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timed Up and Go test	Time (in seconds) to complete the Timed Up and Go test	First day of joining the study
Star Excursion Balance Test	Reach (in centimetres) to achieve during the Star Excursion Balance Test	First day of joining the study
Postural stability	Anterior-Posterior and latero-medial movement (in centimetres) of the centre of pressure	First day of joining the study
Dynamic stability	Variability (standard deviations) of spatio-temporal gait characteristics	First day of joining the study
Muscle activity	Electromyography activity for selected lower leg muscles and expressed in millivolts	First day of joining the study
Perceived attractiveness	Scored on a 100-millimetres (mm) visual analogue scale with 0 mm being "extremely unattractive" and 100 mm being "extremely attractive"	First day of joining the study
Perceived attractiveness for others	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"	First day of joining the study
Perceived comfort	Scored on a 100-millimetres (mm) visual analogue scale with 0 mm being "extremely uncomfortable" and 100 mm being "extremely comfortable"	First day of joining the study
Perceived weight	Scored on a 100-millimetres (mm) visual analogue scale with 0 mm being "extremely light" and 100 mm being "extremely heavy"	First day of joining the study
Perceived fit	Scored on a 100-millimetres (mm) visual analogue scale with 0 mm being "poorest fit possible" and 100 mm being "best fit possible"	First day of joining the study
Perceived ease of use	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"	First day of joining the study
Perceived stability	Scored on a 100-millimetres (mm) visual analogue scale with 0 mm being "extremely unstable" and 100 mm being "extremely stable"	First day of joining the study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validity of "smart" shoe insoles	Validity of Arion insoles against Qualisys Motion Capture System	First day of joining the study
Adherence to wearing minimal shoes in daily life	Adherence to wearing minimal shoes with "smart" shoe insoles assessed with an online questionnaire and expressed in total time in days and hours	The assessment will be performed at 2 weeks
Satisfaction of wearing minimal shoes in daily life	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.	The assessment will be performed at 2 weeks
Gait characteristics during daily life	Gait characteristics, assessed with "smart" shoe insoles, during activities of daily life and expressed in spatio-temporal metrics	The assessment will be performed at 2 weeks

Collaborators and Investigators

• Sponsor: University of Liverpool
• Collaborators: Liverpool University Hospitals NHS Foundation Trust
• Investigators: Principal Investigator: Kristiaan D'Août, PhD, University of Liverpool

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 20, 2019
• Primary Completion (ACTUAL): March 1, 2020
• Study Completion (ACTUAL): March 1, 2020

Study Registration Dates

• First Submitted: March 12, 2019
• First Submitted That Met QC Criteria: March 12, 2019
• First Posted (ACTUAL): March 14, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 3, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Gait; Stability; Muscle activity; Falls; Footwear; Minimal shoes; Smart shoe insoles
• Other Study ID Numbers: 4151

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No