Aging, Falls
Conditions
Keywords
Falls, Gait, Stability, Muscle activity, Footwear, Minimal shoes, Smart shoe insoles
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.
Interventions
OTHERMinimal shoes
A minimal shoe (Vivobarefoot Ltd., London, UK) will be used.
OTHERStandardised 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.
OTHERBarefoot
Participants will conduct the assessments barefoot.
OTHERSmart shoe insoles
Arion pressure-measuring insoles (Eindhoven, The Netherlands) will be used in the study.
Sponsors
Liverpool University Hospitals NHS Foundation Trust
University of Liverpool
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Validity of smart shoe insoles | First day of joining the study | Validity of Arion insoles against Qualisys Motion Capture System |
Countries
United Kingdom
Outcome results
None listed