Feasibility and Acceptability of HOLOBalance Compared to Standard Care in Older Adults at Risk for Falls
- Conditions
- Accidental FallsAgingVestibular Disorder
- Interventions
- Device: HOLOBalanceOther: OTAGO Home Exercise Programme
- Registration Number
- NCT04053829
- Lead Sponsor
- King's College London
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HOLOBalance HOLOBalance The experimental arm will use the HOLOBalance tele-rehabilitation system to provide the intervention. Participants will be required to use the HOLOBalance system on a daily basis for the duration of the 8 week study. Although participants will have daily interaction with the HOLOBalance system, they will be free to choose when to complete their exercises. OTAGO Home Exercise Programme OTAGO Home Exercise Programme The comparator for this study is the OTAGO home exercise programme. 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. The OTAGO is well-established and is widely used in clinical practice in the UK for the management of older adults who fall or have increased risk for falling. It has been shown to be well tolerated in older adults in community settings with good adherence rates, and reduces falls rate in older adults by 35%, with greatest effects observed in frailer older women
- Primary Outcome Measures
Name Time Method 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).
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 1: Recruitment Rate Through study completion (12 months) Assessment of recruitment rate of study (% of eligible participants enrolled)
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 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.
- Secondary Outcome Measures
Name Time Method Balance Function Assessment Baseline (Week 0) and Follow up (Week 9) Mini-BESTest. This is a 14-item test that assesses dynamic balance components including anticipatory postural adjustments, reactive postural control, sensory orientation and dynamic gait. The 14 items are scored on a 3 point scale (0-2), with a maximum score of 28 points awarded. Higher scores indicate better task performance.
Cognitive Function Assessment Baseline (Week 0) and Follow up (Week 9) Cambridge Neuropsychological Test Automated Battery (CANTAB). The test battery includes: (i) Motor screening task to assess a participant's general ability to understand and complete tasks and highlights if any sensorimotor or hearing impairments will have an impact on test performance, (ii) Paired Associated Learning assesses visual associative learning and memory, (iii) Spatial Working Memory to assess one's ability to retain and use visuospatial input, (iv) Reaction Time tests a person's mental and motor response speed, (v) Rapid Visual Information Processing assesses the ability to maintain visual attention and continuous performance on a task and (vi) Delayed Matching to Sample tests visual recognition memory and short term visual memory.
Subjective Questionnaire Baseline (Week 0) and Follow up (Week 9) Environmental Mobility Scale. This is a self-report scale assessing the effect of the physical environment on community mobility. Twenty-four features of the physical environment are identified. For each feature, an encounter question (How often do you?) is paired with an avoidance question (How often do you avoid?). Subjects report on frequency of encounter and avoidance behaviour using a five-point ordinal scale (never, rarely, sometimes, often, always). The test-retest reliability of the questionnaire is good.
Trial Locations
- Locations (1)
King's College London
🇬🇧London, United Kingdom