Clinical trial NCT04053829: Feasibility and Acceptability of HOLOBalance Compared to Standard Care in Older Adults at Risk for Falls
Official 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Accidental Falls
Aging
Vestibular Disorder
Keywords: Rehabilitation
Tele-rehabilitation
Physical Therapy
Coaching
Physical Activity
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: University College, London
name: Horizon 2020 - European Commission
name: University of Ioannina
name: Roessingh Research and Development
name: University of Athens
name: University Hospital Freiburg
First posted: 2019-08-13
Enrollment: 120
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Acceptability Assessment 1: Recruitment Rate
timeFrame: Through study completion (12 months)
measure: Acceptability Assessment 2: Programme Compliance
timeFrame: Through study completion (12 months)
measure: Acceptability Assessment 3: Drop out rate
timeFrame: Through study completion (12 months)
measure: Acceptability 4: Qualitative interview
timeFrame: Collected at end of each participants participation in the study (After 8 weeks)
measure: Feasibility of providing HOLOBalance 1: Monitoring of Adverse and Serious Adverse Events
timeFrame: Through study completion (12 months)
measure: Feasibility of providing HOLOBalance 2: Monitoring for deviations from study protocol
timeFrame: Through study completion (12 months)
Secondary outcomes:
measure: Balance Function Assessment
timeFrame: Baseline (Week 0) and Follow up (Week 9)
measure: Balance Function Assessment
timeFrame: Baseline (Week 0) and Follow up (Week 9)
measure: Cognitive Function Assessment
timeFrame: Baseline (Week 0) and Follow up (Week 9)
measure: Cognitive Function Assessment
timeFrame: Baseline (Week 0) and Follow up (Week 9)
measure: Subjective Questionnaire
timeFrame: Baseline (Week 0) and Follow up (Week 9)
measure: Subjective Questionnaire
timeFrame: Baseline (Week 0) and Follow up (Week 9)
measure: Subjective Questionnaire
timeFrame: Baseline (Week 0) and Follow up (Week 9)
measure: Subjective Questionnaire
timeFrame: Baseline (Week 0) and Follow up (Week 9)
measure: Subjective Questionnaire
timeFrame: Baseline (Week 0) and Follow up (Week 9)
measure: Subjective Questionnaire
timeFrame: Baseline (Week 0) and Follow up (Week 9)
measure: Subjective Questionnaire
timeFrame: Baseline (Week 0) and Follow up (Week 9)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College London
Study officials:
affiliation: University College, London
name: Doris-Eva Bamiou, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: King's College London
name: Marousa Pavlou, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tsakanikas V, Gatsios D, Pardalis A, Tsiouris KM, Georga E, Bamiou DE, Pavlou M, Nikitas C, Kikidis D, Walz I, Maurer C, Fotiadis D. Automated Assessment of Balance Rehabilitation Exercises With a Data-Driven Scoring Model: Algorithm Development and Validation Study. JMIR Rehabil Assist Technol. 2022 Aug 31;9(3):e37229. doi: 10.2196/37229.
citation: Liston M, Genna G, Maurer C, Kikidis D, Gatsios D, Fotiadis D, Bamiou DE, Pavlou M. Investigating the feasibility and acceptability of the HOLOBalance system compared with standard care in older adults at risk for falls: study protocol for an assessor blinded pilot randomised controlled study. BMJ Open. 2021 Feb 12;11(2):e039254. doi: 10.1136/bmjopen-2020-039254.