Aging Clinical Trial
— HOLOBALANCEOfficial title:
A Phase 2 Study to Investigate the Feasibility and Acceptability of the HOLOBalance System Compared to Standard Care in Older Adults at Risk for Falls: a Multi-site Study
NCT number | NCT04053829 |
Other study ID # | 76957 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2020 |
Est. completion date | April 2021 |
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.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | April 2021 |
Est. primary completion date | April 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years to 80 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | King's College London | London |
Lead Sponsor | Collaborator |
---|---|
King's College London | Horizon 2020 - European Commission, Roessingh Research and Development, University College, London, University Hospital Freiburg, University of Athens, University of Ioannina |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Acceptability Assessment 1: Recruitment Rate | Assessment of recruitment rate of study (% of eligible participants enrolled) | Through study completion (12 months) | |
Primary | 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). | Through study completion (12 months) | |
Primary | 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). | Through study completion (12 months) | |
Primary | Acceptability 4: Qualitative interview | Acceptability of HOLOBalance to older adults will be investigated via exit interviews performed within the tele-rehabilitation intervention arm. | Collected at end of each participants participation in the study (After 8 weeks) | |
Primary | 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). | Through study completion (12 months) | |
Primary | 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. | Through study completion (12 months) | |
Secondary | 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. | Baseline (Week 0) and Follow up (Week 9) | |
Secondary | 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. | Baseline (Week 0) and Follow up (Week 9) | |
Secondary | 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) | Baseline (Week 0) and Follow up (Week 9) | |
Secondary | 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. | Baseline (Week 0) and Follow up (Week 9) | |
Secondary | 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 | Baseline (Week 0) and Follow up (Week 9) | |
Secondary | 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. | Baseline (Week 0) and Follow up (Week 9) | |
Secondary | 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. | Baseline (Week 0) and Follow up (Week 9) | |
Secondary | 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 | Baseline (Week 0) and Follow up (Week 9) | |
Secondary | 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) | Baseline (Week 0) and Follow up (Week 9) | |
Secondary | 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". | Baseline (Week 0) and Follow up (Week 9) | |
Secondary | 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. | Baseline (Week 0) and Follow up (Week 9) |
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