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

Completed

• Conditions: Aging; Falls
• Interventions: Other: Minimal shoes; Other: Standardised conventional shoes; Other: Barefoot; Other: "Smart" shoe insoles

• Registration Number: NCT03874728
• Lead Sponsor: University of Liverpool

Brief 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.

Study Timeline

• Study First Submitted: 2019-03-12
• Study First Submitted QC: 2019-03-12
• Study First Posted: 2019-03-14
• Study Start: 2019-11-20
• Primary Completion: 2020-03-01
• Study Completion: 2020-03-01
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-03
• Last Update Posted: 2020-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Older people at risk of falls	Barefoot	Older people at risk of falls
Older people at risk of falls	Minimal shoes	Older people at risk of falls
Older people at risk of falls	Standardised conventional shoes	Older people at risk of falls
Older people at risk of falls	"Smart" shoe insoles	Older people at risk of falls

Primary Outcome Measures

Name	Time	Method
Star Excursion Balance Test	First day of joining the study	Reach (in centimetres) to achieve during the Star Excursion Balance Test
Perceived ease of use	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"
Perceived stability	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"
Perceived attractiveness for others	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"
Timed Up and Go test	First day of joining the study	Time (in seconds) to complete the Timed Up and Go test
Postural stability	First day of joining the study	Anterior-Posterior and latero-medial movement (in centimetres) of the centre of pressure
Dynamic stability	First day of joining the study	Variability (standard deviations) of spatio-temporal gait characteristics
Perceived attractiveness	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"
Perceived comfort	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"
Perceived weight	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"
Perceived fit	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"
Muscle activity	First day of joining the study	Electromyography activity for selected lower leg muscles and expressed in millivolts

Secondary Outcome Measures

Name	Time	Method
Validity of "smart" shoe insoles	First day of joining the study	Validity of Arion insoles against Qualisys Motion Capture System
Adherence to wearing minimal shoes in daily life	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
Satisfaction of wearing minimal shoes in daily life	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.
Gait characteristics during daily life	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

Trial Locations

Locations (1)

University of Liverpool; 🇬🇧 Liverpool, Merseyside, United Kingdom