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

U

University of Liverpool

Status

Completed

Conditions

Aging
Falls

Treatments

Other: Barefoot
Other: Minimal shoes
Other: "Smart" shoe insoles
Other: Standardised conventional shoes

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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

Trial design

30 participants in 1 patient group

Older people at risk of falls
Description:
Older people at risk of falls
Treatment:
Other: Barefoot
Other: Minimal shoes
Other: "Smart" shoe insoles
Other: Standardised conventional shoes

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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