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| Name | Class |
|---|---|
| Liverpool University Hospitals NHS Foundation Trust | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Older people at risk of falls | Older people at risk of falls |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimal shoes | Other | A minimal shoe (Vivobarefoot Ltd., London, UK) will be used. |
|
| 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 |
| 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 |
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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:
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Community-dwelling older adults
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| Name | Affiliation | Role |
|---|---|---|
| Kristiaan D'Août, PhD | University of Liverpool | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Liverpool | Liverpool | Merseyside | L8 0TL | United Kingdom |
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| ID | Term |
|---|---|
| D003150 | Community Health Workers |
| ID | Term |
|---|---|
| D000488 | Allied Health Personnel |
| D006282 | Health Personnel |
| D005159 | Health Care Facilities Workforce and Services |
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| Standardised conventional shoes | Other | 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. |
|
| Barefoot | Other | Participants will conduct the assessments barefoot. |
|
| "Smart" shoe insoles | Other | Arion pressure-measuring insoles (Eindhoven, The Netherlands) will be used in 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 |
| 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 |