Ignite Creation Date:
2025-12-24 @ 5:50 PM
Ignite Modification Date:
2025-12-27 @ 1:16 AM
Study NCT ID:
NCT02696668
Status:
UNKNOWN
Last Update Posted:
2017-03-10
First Post:
2016-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Advances in Group-based Falls Rehabilitation
Sponsor:
King's College London
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2017-03
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: