Feasibility and Acceptability of HOLOBalance Compared to Standard Care in Older Adults at Risk for Falls

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.

Conditions

• Accidental Falls
• Aging
• Vestibular Disorder

Interventions

OTHER

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. 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.

DEVICE

HOLOBalance

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.

Sponsors & Collaborators

• University College, London

  collaborator OTHER

• Horizon 2020 - European Commission

  collaborator OTHER

• University of Ioannina

  collaborator OTHER

• Roessingh Research and Development

  collaborator OTHER

• University of Athens

  collaborator OTHER

• University Hospital Freiburg

  collaborator OTHER

• King's College London

  lead OTHER

Principal Investigators

• Doris-Eva Bamiou, PhD · University College, London

• Marousa Pavlou, PhD · King's College London

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-09-30

Primary Completion

2021-04-30

Completion

2021-04-30

Countries

• United Kingdom

Study Locations