Clinical trial NCT03874728: The Effects of Minimal Shoes in Older People at Risk of Falls: The Feetback Shoe Study
Official title: Preventing Falls in Older People Using an Innovative Connected Shoe: Development & Biomechanics Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Falls
Aging
Keywords: Falls
Gait
Stability
Muscle activity
Footwear
Minimal shoes
Smart shoe insoles
Lead sponsor: University of Liverpool
Sponsor class: OTHER
Collaborators: name: Liverpool University Hospitals NHS Foundation Trust
First posted: 2019-03-14
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community-dwelling older adults

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.

Eligibility criteria: 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

Primary outcomes:
measure: Timed Up and Go test
timeFrame: First day of joining the study
measure: Star Excursion Balance Test
timeFrame: First day of joining the study
measure: Postural stability
timeFrame: First day of joining the study
measure: Dynamic stability
timeFrame: First day of joining the study
measure: Muscle activity
timeFrame: First day of joining the study
measure: Perceived attractiveness
timeFrame: First day of joining the study
measure: Perceived attractiveness for others
timeFrame: First day of joining the study
measure: Perceived comfort
timeFrame: First day of joining the study
measure: Perceived weight
timeFrame: First day of joining the study
measure: Perceived fit
timeFrame: First day of joining the study
measure: Perceived ease of use
timeFrame: First day of joining the study
measure: Perceived stability
timeFrame: First day of joining the study
Secondary outcomes:
measure: Validity of "smart" shoe insoles
timeFrame: First day of joining the study
measure: Adherence to wearing minimal shoes in daily life
timeFrame: The assessment will be performed at 2 weeks
measure: Satisfaction of wearing minimal shoes in daily life
timeFrame: The assessment will be performed at 2 weeks
measure: Gait characteristics during daily life
timeFrame: The assessment will be performed at 2 weeks
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: University of Liverpool
state: Merseyside
Study officials:
affiliation: University of Liverpool
name: Kristiaan D'Août, PhD
role: PRINCIPAL_INVESTIGATOR
References: