FallsFSSNCT03874728
The Effects of Minimal Shoes in Older People at Risk of Falls: The Feetback Shoe Study
An observational study of Falls and Aging, run by University of Liverpool at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- What is being tested?
- Minimal shoes, Standardised conventional shoes and Barefoot
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Nov 2019to 1 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Community-dwelling older adults
Who may be able to join
- Age: ≥ 60 years old
- One of the vulnerability criteria for risk falls:
- ≥ 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Liverpool
Liverpool, Merseyside, L8 0TL
About this study
Official title: Preventing Falls in Older People Using an Innovative Connected Shoe: Development & Biomechanics Study.
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.
Read the 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.
- Being tested
- Minimal shoes, Standardised conventional shoes, Barefoot, "Smart" shoe insoles
- Keywords
- Falls, Gait, Stability, Muscle activity, Footwear, Minimal shoes, Smart shoe insoles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimal shoesOther
A minimal shoe (Vivobarefoot Ltd., London, UK) will be used.
Standardised conventional shoesOther
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.
BarefootOther
Participants will conduct the assessments barefoot.
"Smart" shoe insolesOther
Arion pressure-measuring insoles (Eindhoven, The Netherlands) will be used in the study.
| Study group | Role | What they receive |
|---|---|---|
| Older people at risk of falls | Older people at risk of falls Receives: Other: Minimal shoes; Other: Standardised conventional shoes; Other: Barefoot; Other: "Smart" shoe insoles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Up and Go test
Time (in seconds) to complete the Timed Up and Go test
Measured: First day of joining the study
Star Excursion Balance Test
Reach (in centimetres) to achieve during the Star Excursion Balance Test
Measured: First day of joining the study
Postural stability
Anterior-Posterior and latero-medial movement (in centimetres) of the centre of pressure
Measured: First day of joining the study
Dynamic stability
Variability (standard deviations) of spatio-temporal gait characteristics
Measured: First day of joining the study
Muscle activity
Electromyography activity for selected lower leg muscles and expressed in millivolts
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: First day of joining the study
Secondary outcomes (4)
Validity of "smart" shoe insoles
Validity of Arion insoles against Qualisys Motion Capture System
Measured: 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
Measured: 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.
Measured: 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
Measured: The assessment will be performed at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start20 Nov 2019
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FallsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liverpool
- Sponsor type
- University, hospital or other
- Collaborators
- Liverpool University Hospitals NHS Foundation Trust
- Responsible party
- Principal investigator, Tomasz Cudejko, University of Liverpool
- Investigators
- Kristiaan D'Août, PhD, Principal investigator, University of Liverpool
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03874728
- Sponsor's protocol ID
- 4151
- Acronym
- FSS
- Status last verified
- Jul 2020
- First submitted
- 12 Mar 2019
- Last updated
- 7 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Falls in Older People Using an Innovative Connected Shoe: Development & Biomechanics Study.
- ClinicalTrials.gov ID
- NCT03874728
- Acronym / sponsor ID
- FSS / 4151
- Keywords
- Falls, Gait, Stability, Muscle activity, Footwear, Minimal shoes, Smart shoe insoles
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of LiverpoolUniversity, hospital or other
- Collaborators
- Liverpool University Hospitals NHS Foundation Trust
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 14 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Older people at risk of falls | – | Other: Minimal shoes, Other: Standardised conventional shoes, Other: Barefoot, Other: "Smart" shoe insolesOlder people at risk of falls |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community-dwelling older adults
Key inclusion criteria (3 listed)
- Age: ≥ 60 years old
- One of the vulnerability criteria for risk falls:
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimal shoesA minimal shoe (Vivobarefoot Ltd., London, UK) will be used. | Other | Older people at risk of falls |
| Standardised conventional shoesThe 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 | Older people at risk of falls |
| BarefootParticipants will conduct the assessments barefoot. | Other | Older people at risk of falls |
| "Smart" shoe insolesArion pressure-measuring insoles (Eindhoven, The Netherlands) will be used in the study. | Other | Older people at risk of falls |
Primary outcome
Timed Up and Go test
Time frame: First day of joining the study
Time (in seconds) to complete the Timed Up and Go test
Star Excursion Balance Test
Time frame: First day of joining the study
Reach (in centimetres) to achieve during the Star Excursion Balance Test
Postural stability
Time frame: First day of joining the study
Anterior-Posterior and latero-medial movement (in centimetres) of the centre of pressure
Dynamic stability
Time frame: First day of joining the study
Variability (standard deviations) of spatio-temporal gait characteristics
Muscle activity
Time frame: First day of joining the study
Electromyography activity for selected lower leg muscles and expressed in millivolts
Perceived attractiveness
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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"
4 secondary outcomes
Validity of "smart" shoe insoles
Time frame: First day of joining the study
Adherence to wearing minimal shoes in daily life
Time frame: The assessment will be performed at 2 weeks
Satisfaction of wearing minimal shoes in daily life
Time frame: The assessment will be performed at 2 weeks
Gait characteristics during daily life
Time frame: The assessment will be performed at 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristiaan D'Août, PhD principal investigator
University of Liverpool
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Falls and Aging, run by University of Liverpool at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed Up and Go test (time frame: First day of joining the study). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.