Preventing Falls in Older People Using an Innovative Connected Shoe: Development & Biomechanics Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Star Excursion Balance Test
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Macro-vascular symptoms (angina, stroke or a peripheral vascular disease)
- •Neuromuscular diseases (Multiple Sclerosis, Alzheimer Disease or Parkinson Disease)
- •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
结局指标
主要结局
Star Excursion Balance Test
时间窗: First day of joining the study
Reach (in centimetres) to achieve during the Star Excursion Balance Test
Perceived ease of use
时间窗: 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
时间窗: 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 attractiveness for others
时间窗: 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"
Timed Up and Go test
时间窗: First day of joining the study
Time (in seconds) to complete the Timed Up and Go test
Perceived attractiveness
时间窗: 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"
Postural stability
时间窗: First day of joining the study
Anterior-Posterior and latero-medial movement (in centimetres) of the centre of pressure
Dynamic stability
时间窗: First day of joining the study
Variability (standard deviations) of spatio-temporal gait characteristics
Perceived comfort
时间窗: 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
时间窗: 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
时间窗: 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"
Muscle activity
时间窗: First day of joining the study
Electromyography activity for selected lower leg muscles and expressed in millivolts
次要结局
- 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)
研究者
Tomasz Cudejko
Study coordinator
University of Liverpool