NCT03874728

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: University of Liverpool · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Falls
• Aging

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-11-20
• Primary completion: 2020-03-01
• Completion: 2020-03-01
• First posted: 2019-03-14
• Last updated: 2020-07-07

Locations

1 site across 1 country: United Kingdom