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

Study Overview
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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.

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.

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

Conditions
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Falls, Aging

Intervention / Treatment
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* Other: Minimal shoes
* Other: Standardised conventional shoes
* Other: Barefoot
* Other: Smart shoe insoles


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Older people at risk of falls<br>Older people at risk of falls | Other: Minimal shoes<br>* A minimal shoe (Vivobarefoot Ltd., London, UK) will be used.<br>Other: Standardised conventional shoes<br>* 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.<br>Other: Barefoot<br>* Participants will conduct the assessments barefoot.<br>Other: Smart shoe insoles<br>* Arion pressure-measuring insoles (Eindhoven, The Netherlands) will be used in the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed Up and Go test | Time (in seconds) to complete the Timed Up and Go test | First day of joining the study | 
| Star Excursion Balance Test | Reach (in centimetres) to achieve during the Star Excursion Balance Test | First day of joining the study | 
| Postural stability | Anterior-Posterior and latero-medial movement (in centimetres) of the centre of pressure | First day of joining the study | 
| Dynamic stability | Variability (standard deviations) of spatio-temporal gait characteristics | First day of joining the study | 
| Muscle activity | Electromyography activity for selected lower leg muscles and expressed in millivolts | First day of joining the study | 
| Perceived attractiveness | Scored on a 100-millimetres (mm) visual analogue scale with 0 mm being extremely unattractive and 100 mm being extremely attractive | First day of joining the study | 
| Perceived attractiveness for others | 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 | First day of joining the study | 
| Perceived comfort | Scored on a 100-millimetres (mm) visual analogue scale with 0 mm being extremely uncomfortable and 100 mm being extremely comfortable | First day of joining the study | 
| Perceived weight | Scored on a 100-millimetres (mm) visual analogue scale with 0 mm being extremely light and 100 mm being extremely heavy | First day of joining the study | 
| Perceived fit | Scored on a 100-millimetres (mm) visual analogue scale with 0 mm being poorest fit possible and 100 mm being best fit possible | First day of joining the study | 
| Perceived ease of use | 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 | First day of joining the study | 
| Perceived stability | Scored on a 100-millimetres (mm) visual analogue scale with 0 mm being extremely unstable and 100 mm being extremely stable | First day of joining the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validity of smart shoe insoles | Validity of Arion insoles against Qualisys Motion Capture System | First day of joining the study | 
| Adherence to wearing minimal shoes in daily life | Adherence to wearing minimal shoes with smart shoe insoles assessed with an online questionnaire and expressed in total time in days and hours | The assessment will be performed at 2 weeks | 
| Satisfaction of wearing minimal shoes in daily life | 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. | The assessment will be performed at 2 weeks | 
| Gait characteristics during daily life | Gait characteristics, assessed with smart shoe insoles, during activities of daily life and expressed in spatio-temporal metrics | The assessment will be performed at 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stability, Falls, Gait, Muscle activity, Footwear, Minimal shoes, Smart shoe insoles