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

NCT03874728 | Completed

• 1 other identifier: 4151
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Falls; Aging

Keywords

Falls; Gait; Stability; Muscle activity; Footwear; Minimal shoes; Smart shoe insoles

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (4)

• Validity of "smart" shoe insoles

  First day of joining the study

• Adherence to wearing minimal shoes in daily life

  The assessment will be performed at 2 weeks

• Satisfaction of wearing minimal shoes in daily life

  The assessment will be performed at 2 weeks

• Gait characteristics during daily life

  The assessment will be performed at 2 weeks

Study Arms (1)

Older people at risk of falls

Older people at risk of falls

Other: Minimal shoes; Other: Standardised conventional shoes; Other: Barefoot; Other: "Smart" shoe insoles

Interventions

Minimal shoes OTHER

A minimal shoe (Vivobarefoot Ltd., London, UK) will be used.

Older people at risk of falls

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.

Older people at risk of falls

Barefoot OTHER

Participants will conduct the assessments barefoot.

Older people at risk of falls

"Smart" shoe insoles OTHER

Arion pressure-measuring insoles (Eindhoven, The Netherlands) will be used in the study.

Older people at risk of falls

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community-dwelling older adults

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Liverpool: lead
• Liverpool University Hospitals NHS Foundation Trust: collaborator

Study Sites (1)

University of Liverpool

Liverpool, Merseyside, L8 0TL, United Kingdom

Location

MeSH Terms

Interventions

Community Health Workers

Intervention Hierarchy (Ancestors)

Allied Health Personnel; Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Kristiaan D'Août, PhD

  University of Liverpool

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study coordinator

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: March 14, 2019
• Study Start: November 20, 2019
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: July 7, 2020

Record last verified: 2020-07

Locations

GB (1)