Advances in Group-based Falls Rehabilitation
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
1 other identifier
interventional
100
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2017
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2016
CompletedFirst Posted
Study publicly available on registry
March 2, 2016
CompletedStudy Start
First participant enrolled
May 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2020
CompletedMarch 10, 2017
March 1, 2017
2.6 years
February 25, 2016
March 8, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Functional Gait Assessment
A 10-item test assesses complex gait tasks such as walking with head turns or stepping over an obstacle
Baseline (prior to start of intervention), 8 weeks, 16 weeks and 32 weeks
Secondary Outcomes (8)
Timed Up and Go test
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
Activities-Specific Balance Confidence Scale
Baseline (prior to start of intervention), 8 weeks, 16 weeks and 32 weeks
Falls Efficacy Scale - International
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
- +3 more secondary outcomes
Other Outcomes (1)
Cantab Dementia Battery
Baseline (prior to start of intervention), 8 weeks, 16 weeks and 32 weeks
Study Arms (2)
modified FaME
ACTIVE COMPARATORParticipants 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.
Multisensory
EXPERIMENTALParticipants in the multisensory group will receive balance exercises training which will be tailored and progressed to their abilities and needs.
Interventions
Group based exercise classes one hour weekly for 16 weeks. Each exercise class will have 8-10 participants and two instructors. The components of the FaME programme include specific falls management strategies, such as bone loading, gait, dynamic posture, balance, reaction and co-ordination training, functional floor activities to improve coping skills and confidence.
Group based exercise classes one hour weekly for 16 weeks. Each exercise class will have 8-10 participants and two instructors.Participants will receive an initial assessment by the research physiotherapists to determine the most appropriate interventions for each participant. Interventions used will include: 1. Limits of stability training with eyes open / eyes closed 2. Self induced movement strategies with eyes open / eyes closed 3. Gaze stability exercises in sitting / standing / walking 4. Sensory integration 5. Habituation exercises
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- King's College Londonlead
- University College London Hospitalscollaborator
- Guy's and St Thomas' NHS Foundation Trustcollaborator
- St George's University Hospitals NHS Foundation Trustcollaborator
Study Officials
- PRINCIPAL INVESTIGATOR
Marousa Pavlou, PhD
King's College London
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2016
First Posted
March 2, 2016
Study Start
May 1, 2017
Primary Completion
December 1, 2019
Study Completion
March 1, 2020
Last Updated
March 10, 2017
Record last verified: 2017-03