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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
120
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.
King's College London
London, United Kingdom
RECRUITINGAcceptability Assessment 1: Recruitment Rate
Assessment of recruitment rate of study (% of eligible participants enrolled)
Time frame: Through study completion (12 months)
Acceptability Assessment 2: Programme Compliance
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).
Time frame: Through study completion (12 months)
Acceptability Assessment 3: Drop out rate
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).
Time frame: Through study completion (12 months)
Acceptability 4: Qualitative interview
Acceptability of HOLOBalance to older adults will be investigated via exit interviews performed within the tele-rehabilitation intervention arm.
Time frame: Collected at end of each participants participation in the study (After 8 weeks)
Feasibility of providing HOLOBalance 1: Monitoring of Adverse and Serious Adverse Events
Feasibility will be assessed by documenting adverse events (and SAE's) and adverse device effects (and SADE's).
Time frame: Through study completion (12 months)
Feasibility of providing HOLOBalance 2: Monitoring for deviations from study protocol
Assessment of any deviations from protocol reported logged in the site files using the deviation from protocol form.
Time frame: Through study completion (12 months)
Balance Function Assessment
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.
Time frame: Baseline (Week 0) and Follow up (Week 9)
Balance Function Assessment
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.
Time frame: Baseline (Week 0) and Follow up (Week 9)
Cognitive Function Assessment
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)
Time frame: Baseline (Week 0) and Follow up (Week 9)
Cognitive Function Assessment
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.
Time frame: Baseline (Week 0) and Follow up (Week 9)
Subjective Questionnaire
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
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Time frame: Baseline (Week 0) and Follow up (Week 9)
Subjective Questionnaire
WHO Disability Assessment Schedule 2.0. This is an assessment which provides a global measure of disability. It covers the following domains of functioning: Cognition - understanding \& communicating; Mobility- moving \& getting around; Self-care- hygiene, dressing, eating \& staying alone; Getting along- interacting with other people; Life activities- domestic responsibilities, leisure, work \& school; Participation- joining in community activities.
Time frame: Baseline (Week 0) and Follow up (Week 9)
Subjective Questionnaire
Activities-Specific Balance Confidence Scale (ABC). This questionnaire assesses patients perceived confidence for performing 16-activities of daily living without losing balance. Scores ≤67/100% indicate increased falls risk.
Time frame: Baseline (Week 0) and Follow up (Week 9)
Subjective Questionnaire
Falls Self-Efficacy Scale International. This is a short, easy to administer tool measuring an individual's level of concern regarding falling during social and physical activities inside and outside the home, whether or not the person actually does the activity. Level of concern is measured on a four-point Likert scale (1=not at all to 4=very). It has excellent internal validity and test-retest reliability. Scores of \>23 for the long form and \>10 for the short form have been suggested as cut points for indicating high concern about falling
Time frame: Baseline (Week 0) and Follow up (Week 9)
Subjective Questionnaire
Behavioral Regulation in Exercise Questionnaire (BREQ-3). This is a 24 item questionnaire to assess motivation to exercise. Participants rate whether statements apply to themselves (or not) using a 5 point likertLikert scale ranging from 0 (Not true for me) to 4 (Very true for me)
Time frame: Baseline (Week 0) and Follow up (Week 9)
Subjective Questionnaire
EQ-5D-5L. This is a standardized, valid and reliable simple, generic measure of health status for clinical and economic appraisal. The EQ-5D-5L has 5 dimensions (mobility, selfcare, usual activities, pain/discomfort, anxiety/depression) and includes the EQ visual Analogue scale (EQ VAS). The respondent is asked to rate their health status on these five dimensions from 1 to 5 respectively as no problems, slight problems, moderate problems, severe problems, and extreme problems. The EQ VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labeledlabelled 'the best health you can imagine' and 'the worst health you can imagine'. The respondent is asked to mark an X on the scale to indicate "how your health is TODAY".
Time frame: Baseline (Week 0) and Follow up (Week 9)
Subjective Questionnaire
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.
Time frame: Baseline (Week 0) and Follow up (Week 9)