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

Sponsor

University of Liverpool (Other)

Overall Status

Completed

CT.gov ID

NCT03874728

Collaborator

Liverpool University Hospitals NHS Foundation Trust (Other)

Enrollment

Location

3.4

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Falls Aging	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 Design

Study Type:

Observational

Actual Enrollment :

30 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Nov 20, 2019

Actual Primary Completion Date :

Mar 1, 2020

Actual Study Completion Date :

Mar 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Older people at risk of falls 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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Timed Up and Go test [First day of joining the study]
Time (in seconds) to complete the Timed Up and Go test
Star Excursion Balance Test [First day of joining the study]
Reach (in centimetres) to achieve during the Star Excursion Balance 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
Muscle activity [First day of joining the study]
Electromyography activity for selected lower leg muscles and expressed in millivolts
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 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"
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"
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"

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts 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