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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-20

Study Completion Date

2020-03-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Falls Aging

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Older people at risk of falls

Minimal shoes

Intervention Type OTHER

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

Standardised conventional shoes

Intervention Type 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

Intervention Type OTHER

Participants will conduct the assessments barefoot.

"Smart" shoe insoles

Intervention Type OTHER

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

Interventions

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Minimal shoes

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

Intervention Type 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.

Intervention Type OTHER

Barefoot

Participants will conduct the assessments barefoot.

Intervention Type OTHER

"Smart" shoe insoles

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No