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临床试验/NCT02696668
NCT02696668Unknown不适用

The Effect of a Modified FaME vs. a Multisensory Group Balance Programme on Falls Risk, Balance Confidence and Quality of Life in Older Adult Who Fall or Are at Risk of Falling

King's College London0 个研究点目标入组 100 人开始时间: 2017年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
100
主要终点
Functional Gait Assessment

研究概览

简要总结

This study's main aim is to compare the effect of a modified FaME vs. a multisensory balance exercise programme on falls risk, balance confidence and quality of life in older adults who fall or at risk of falling when implemented in a group setting.

详细描述

Falls in older adults have a major impact on health, morbidity and mortality and have significant cost implications to healthcare providers (Alexander et al., 1992, Tinetti and Williams, 1998, Davis et al., 2010). Government legislation states targeted multifactorial falls rehabilitation programmes should be provided to older adult fallers (Excellence, 2013). The FaME programme, a group based rehabilitation programme is reported effective for improving balance and walking speed, and reducing the number of falls, chance of hospitalization, institutionalization, and death, and fear of falling (Skelton et al., 2005, Yeung et al., 2014). Sensory integration and re-weighting of peripheral sensory information from visual, somatosensory, and vestibular (i.e. inner ear) systems play an important role in maintaining balance (Horak, 2006). However, until recently no studies had incorporated vestibular exercises into falls rehabilitation programmes and therefore, the efficacy of this type of multisensory balance programme in older adult fallers was unknown.

A recent study showed that a programme combining the widely used modified OTAGO falls rehabilitation programme with multisensory balance exercises was feasible in older adult fallers and may have a greater beneficial effect on balance, gait, and falls risk compared to the OTAGO programme in isolation (Liston et al., 2014). However, multisensory rehabilitation targeting sensory integration and re-weighting which is crucial for postural control is not addressed in current guidelines. To develop the best programme for fall prevention, understanding the complexity of postural control and defining a specified exercise programme targeting essential systems is required. The FaME programme includes certain multisensory balance exercises, but these are introduced only in the latter phase of the programme. This study's main aim is to compare the effect of a modified FaME vs. a multisensory balance exercise programme on falls risk, balance confidence and quality of life in older adults who fall or at risk of falling when implemented in a group setting.

Research questions:

Primary research question:

Does exposure to multisensory balance rehabilitation provide better outcome in balance confidence, falls risk and quality of life in older adult who fall or are at risk of falling compared to the modified FaME programme?

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Older adult 65 years old or older who have either experienced a fall or are at risk of falling (Timed Up and Go score >15 seconds) and have been referred by the assessing physiotherapist to a falls rehabilitation group class.

排除标准

  • •Older adults who have:
  • •i) Cardiac syncope/pre-syncope ii) Postural hypotension iii) A Mini Mental State score of <24/
  • •ii) Diagnosis of dementia or mild cognitive impairment ii) Acute illness iii) Side effects of medication or drug intoxication iv) Evident musculo-skeletal or neurological deficit that is likely to contribute to postural instability
  • •Any individual with poor written/spoken English will not be included in the study due to the need to complete multiple questionnaires.
  • •Individuals with a known history of epilepsy in the last one year or currently experiencing migraine will not be included in this study due to the use of optokinetic stimuli.

研究组 & 干预措施

modified FaME

Active Comparator

Participants in the modified FaME group will receive a 16 weeks falls rehabilitation programme which will be tailored and progressed according to their abilities and their needs by the physiotherapist / instructor providing the rehabilitation at the hospital.

干预措施: modified FaME (Other)

Multisensory

Experimental

Participants in the multisensory group will receive balance exercises training which will be tailored and progressed to their abilities and needs.

干预措施: Multisensory (Other)

结局指标

主要结局

Functional Gait Assessment

时间窗: Baseline (prior to start of intervention), 8 weeks, 16 weeks and 32 weeks

A 10-item test assesses complex gait tasks such as walking with head turns or stepping over an obstacle

次要结局

  • Vestibular Symptom Scale(Baseline (prior to start of intervention), 8 weeks, 16 weeks, 32 weeks and one year)
  • Timed Up and Go test(Baseline (prior to start of intervention), 8 weeks, 16 weeks and 32 weeks)
  • Activities-Specific Balance Confidence Scale(Baseline (prior to start of intervention), 8 weeks, 16 weeks and 32 weeks)
  • Mini Balance Evaluation Systems Test(Baseline (prior to start of intervention), 8 weeks, 16 weeks and 32 weeks)
  • Environmental Analysis of Mobility Questionnaire(Baseline (prior to start of intervention), 8 weeks, 16 weeks, 32 weeks and one year)
  • Hospital Anxiety and Depression Scale(Baseline (prior to start of intervention), 8 weeks, 16 weeks, 32 weeks and one year)
  • EQ-5D self-report questionnaire(Baseline (prior to start of intervention), 8 weeks, 16 weeks, 32 weeks and one year)
  • Falls Efficacy Scale - International(Baseline (prior to start of intervention), 8 weeks, 16 weeks and 32 weeks)

研究者

申办方类型
Other
责任方
Sponsor

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