Accidental Falls, Aging, Vestibular Disorder
Conditions
Keywords
Rehabilitation, Tele-rehabilitation, Physical Therapy, Coaching, Physical Activity
Brief summary
This study will utilise an assessor blinded, randomised controlled design to investigate the acceptability and feasibility of providing a novel tele-rehabilitation balance training system (HOLOBalance) for community dwelling older adults at risk for falls. Older adults (age 65-80) who meet the inclusion criteria (e.g. independently living, no neurological conditions) will be recruited from falls services and from the wider community (via AgeUK) and will be randomly allocated to receive either a prescribed exercise programme delivered by: 1) the HOLOBalance tele-rehabilitation system or 2) an exercise booklet (The OTAGO Home Exercise Programme). Participants will be required to perform a series of prescribed exercises each day (duration of up to 30 minutes per day) for the entirety of the 8-week exercise programme. These exercises will be provided via the HOLOBalance tele-rehabilitation system (intervention arm) or by written instructions (control arm). Primary objectives for this study are to assess recruitment rate, compliance with exercise programmes (exercise diaries) and drop-out rates within the intervention group and a control group undertaking standard practice, home based balance rehabilitation (the OTAGO Home Exercise Programme) to explore whether HOLOBalance is acceptable to participants. Furthermore, acceptability to older adults will also be investigated via exit interviews performed within the HOLOBalance tele-rehabilitation intervention arm. Feasibility will be assessed by documenting adverse events (and SAE's), adverse device effects (and SADE's), deviations from protocol and feedback from treating clinicians. Implementation issues such as technology break down, service delivery and usability issues will also be documented. Secondary outcomes to explore trends for effectiveness will investigate performance of both groups at baseline and after the 8 week intervention across a range of outcome measures associated with balance function and falls risk, cognitive function, Physical activity and social participation, and subjective report of mobility and balance.
Interventions
DEVICEHOLOBalance
The HOLOBalance tele-rehabilitation system will be used to deliver an evidence based, multi-sensory balance rehabilitation programme to participants, and will deliver a series of exercises prescribed by an expert balance physiotherapist following an initial balance assessment. The HOLOBalance system will use a head mounted augmented reality display to deliver exercises and games to participants and will record task performance via a combination of body worn sensors and a depth camera. The HOLOBalance tele-rehabilitation system will provide feedback to the supervising clinical team regarding task performance, participant usage and user feedback. The system will have daily presence in the users' home with users expected to complete their prescribed rehabilitation on a daily basis, which mirrors the prescribed exercise routines often provided by balance physiotherapists.
The OTAGO is a systematic, progressive strength and balance training programme and is supported by a comprehensive workbook that provides written and pictorial instructions for each exercise. It is well-established and widely used in clinical practice in the UK, and has been shown to reduce falls rate in older adults by 35-40%. It is well tolerated in older adults in community settings with good adherence rates.The OTAGO has also been used as the standard intervention in previous investigations of MSR interventions in older adults. To match intervention and control interventions, participants in the OTAGO group will be asked to complete the OTAGO programme every day for the duration of the 8 week programme.
Sponsors
University College, London
Horizon 2020 - European Commission
University of Ioannina
Roessingh Research and Development
University of Athens
University Hospital Freiburg
King's College London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
Only the outcome assessor will be masked in this study
Intervention model description
This multi-centre, assessor-blinded, randomised proof of concept study will explore the acceptability and feasibility of providing a home-based balance tele-rehabilitation programme to older adults at risk for falls. It will 1) compare acceptability of the tele-health programme (e.g. compliance, drop-out rate) to an established home exercise programme (the OTAGO HEP) and 2) explore trends for effectiveness across a number of validated outcome measures to explore whether a future trial is warranted, and if so to provide data for a sample size estimate. Data will be collected at baseline (week 0) and at completion of the intervention (week 9). The flow of participants through the trial will be recorded in compliance with the CONSORT statement. The blinded outcome assessor will collect all measures at baseline and follow up and will be asked to record any incidences of unblinding and detail how this occurred.
Eligibility
Sex/Gender
ALL
Age
65 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Independent community-dwelling participants able to walk 500 meters independently or with a stick * No significant visual impairment * Able to understand and to consent to the research * A score of \>22 on the MoCA, i.e. adults with no or mild cognitive impairment; * At risk of falls (i.e. FGA less than 22/30), have significant fear of falling (FESI short form \>10) or having experienced a fall/s in the last 12 months * Willing to participate and to comply with the proposed training and testing regime. * Available space of 1x2 metres at home and sufficient home broadband to allow the system to operate as designed
Exclusion criteria
* Orthostatic hypotension or uncontrolled hypertension * Have depression i.e. a score of \>10 at the Geriatric depression scale * Have cognitive impairment as indicated by the MoCA score(score \<22) * Other neurological problem (stroke, Parkinson's, peripheral neuropathy) * Acute musculo-skeletal injury that prevents participation in a structured exercise programme (e.g. lower limb fracture) * No internet connection at home * Has participated in a clinical drug trial in the past 6 months * Currently receiving falls and/or cognitive rehabilitation. * Has an implanted medical device or cardiac pacemaker
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of providing HOLOBalance 2: Monitoring for deviations from study protocol | Through study completion (12 months) | Assessment of any deviations from protocol reported logged in the site files using the deviation from protocol form. |
| Acceptability Assessment 3: Drop out rate | Through study completion (12 months) | Comparison of drop-out rates (%) between the intervention group and a control group undertaking standard practice, home based balance rehabilitation (the OTAGO Home Exercise Programme). |
| Acceptability 4: Qualitative interview | Collected at end of each participants participation in the study (After 8 weeks) | Acceptability of HOLOBalance to older adults will be investigated via exit interviews performed within the tele-rehabilitation intervention arm. |
| Feasibility of providing HOLOBalance 1: Monitoring of Adverse and Serious Adverse Events | Through study completion (12 months) | Feasibility will be assessed by documenting adverse events (and SAE's) and adverse device effects (and SADE's). |
| Acceptability Assessment 1: Recruitment Rate | Through study completion (12 months) | Assessment of recruitment rate of study (% of eligible participants enrolled) |
| Acceptability Assessment 2: Programme Compliance | Through study completion (12 months) | Comparison of compliance with exercise programmes (% of sessions completed) within the intervention group and a control group undertaking standard practice, home based balance rehabilitation (the OTAGO Home Exercise Programme). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive Function Assessment | Baseline (Week 0) and Follow up (Week 9) | Montreal Cognitive Assessment. This test includes sections on visuospatial/executive function (alternating trail-making, cube copy, clock drawing), naming (lion, rhinoceros, camel), attention (forward and backward digit span, tapping to the letter A, subtracting 7s from 100), language (sentence repetition, letter fluency), abstraction (similarities between train and bicycle, watch and ruler), memory (delayed verbal recall of 5 words) and orientation to time and place (6 questions) |
| Subjective Questionnaire | Baseline (Week 0) and Follow up (Week 9) | Rapid Assessment of Physical Activity (RAPA). This is a 9-item, self-administered questionnaire developed to provide an easily administered and interpreted means of assessing levels of physical activity among adults older than 50 years. RAPA evaluates a wide range of physical activity level, from sedentary to vigorous activity, as well as strength and flexibility training |
| Balance Function Assessment | Baseline (Week 0) and Follow up (Week 9) | Functional Gait Assessment. This is a 10-item test that assesses performance on complex gait tasks (e.g. walking with head turns or stopping and turning). Each item is rated on a 4 point scale (0-3) with higher scores indicating better task performance. |
Countries
United Kingdom
Contacts
Primary ContactMatthew Liston, PhD
Outcome results
None listed