HOLOBalance
Research type
Research Study
Full title
A single-blinded randomised controlled study to investigate the feasibility and acceptability of the HOLOBalance system compared to standard care in an ageing population with balance disorders
IRAS ID
248101
Contact name
Marousa Pavlou
Contact email
Sponsor organisation
King's College London
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 11 months, 29 days
Research 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 10-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 10 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.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
19/LO/1908
Date of REC Opinion
7 Feb 2020
REC opinion
Further Information Favourable Opinion