Clinical trial NCT02696668: Advances in Group-based Falls Rehabilitation
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Accidental Falls
Keywords: multisensory exercises
group-based balance exercise programme
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: University College London Hospitals
name: Guy's and St Thomas' NHS Foundation Trust
name: St George's University Hospitals NHS Foundation Trust
First posted: 2016-03-02
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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?

Secondary research questions:

1. What is the long term effect of a multisensory balance rehabilitation programme vs. the modified FaME on all outcome measure scores and falls rate?
2. Is there a relationship between baseline cognitive function, vestibular function and intervention outcome?
3. Can vestibular dysfunction be effectively screened for in a community setting?

Study design:

This study will be a single blinded randomised control study to investigate the effect of the multisensory balance rehabilitation programme vs. the modified FaME on falls risk, balance confidence and quality of life in older adults who fall or are at risk of falling. This study will have two arms provided within a community-based setting. This study will compare intervention outcome between participants receiving the modified FaME falls rehabilitation programme and those receiving multisensory balance rehabilitation exercises.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

1. Older adults who have:

   i) Cardiac syncope/pre-syncope ii) Postural hypotension iii) A Mini Mental State score of \<24/30. 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
2. Any individual with poor written/spoken English will not be included in the study due to the need to complete multiple questionnaires.
3. 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.

Primary outcomes:
measure: Functional Gait Assessment
timeFrame: Baseline (prior to start of intervention), 8 weeks, 16 weeks and 32 weeks
Secondary outcomes:
measure: Timed Up and Go test
timeFrame: Baseline (prior to start of intervention), 8 weeks, 16 weeks and 32 weeks
measure: Mini Balance Evaluation Systems Test
timeFrame: Baseline (prior to start of intervention), 8 weeks, 16 weeks and 32 weeks
measure: Activities-Specific Balance Confidence Scale
timeFrame: Baseline (prior to start of intervention), 8 weeks, 16 weeks and 32 weeks
measure: Falls Efficacy Scale - International
timeFrame: Baseline (prior to start of intervention), 8 weeks, 16 weeks and 32 weeks
measure: Environmental Analysis of Mobility Questionnaire
timeFrame: Baseline (prior to start of intervention), 8 weeks, 16 weeks, 32 weeks and one year
measure: Hospital Anxiety and Depression Scale
timeFrame: Baseline (prior to start of intervention), 8 weeks, 16 weeks, 32 weeks and one year
measure: EQ-5D self-report questionnaire
timeFrame: Baseline (prior to start of intervention), 8 weeks, 16 weeks, 32 weeks and one year
measure: Vestibular Symptom Scale
timeFrame: Baseline (prior to start of intervention), 8 weeks, 16 weeks, 32 weeks and one year
Other outcomes:
measure: Cantab Dementia Battery
timeFrame: Baseline (prior to start of intervention), 8 weeks, 16 weeks and 32 weeks
Locations:
Study officials:
affiliation: King's College London
name: Marousa Pavlou, PhD
role: PRINCIPAL_INVESTIGATOR
References: