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

NCT ID: NCT04053829

Last Updated: 2020-09-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-30
• Study Completion Date: 2021-04-30

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.

Conditions

Accidental Falls; Aging; Vestibular Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

HOLOBalance

The experimental arm will use the HOLOBalance tele-rehabilitation system to provide the intervention. Participants will be required to use the HOLOBalance system on a daily basis for the duration of the 8 week study. Although participants will have daily interaction with the HOLOBalance system, they will be free to choose when to complete their exercises.

Group Type: EXPERIMENTAL

HOLOBalance

Intervention Type: DEVICE

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.

OTAGO Home Exercise Programme

The comparator for this study is the 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. The OTAGO is well-established and is widely used in clinical practice in the UK for the management of older adults who fall or have increased risk for falling. It has been shown to be well tolerated in older adults in community settings with good adherence rates, and reduces falls rate in older adults by 35%, with greatest effects observed in frailer older women

Group Type: ACTIVE_COMPARATOR

OTAGO Home Exercise Programme

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University College, London

OTHER

Sponsor Role: collaborator

Horizon 2020 - European Commission

OTHER

Sponsor Role: collaborator

University of Ioannina

OTHER

Sponsor Role: collaborator

Roessingh Research and Development

OTHER

Sponsor Role: collaborator

University of Athens

OTHER

Sponsor Role: collaborator

University Hospital Freiburg

OTHER

Sponsor Role: collaborator

King's College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Doris-Eva Bamiou, PhD

Role: PRINCIPAL_INVESTIGATOR

University College, London

Marousa Pavlou, PhD

Role: PRINCIPAL_INVESTIGATOR

King's College London

Locations

King's College London

London, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Matthew Liston, PhD

Role: CONTACT

matthew.liston@kcl.ac.uk

+442078486316

Facility Contacts

Matthew Liston, PhD

Role: primary

matthew.liston@kcl.ac.uk

0207 848 6679

References

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.

Reference Type: DERIVED

PMID: 36044258 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33579762 (View on PubMed)

Related Links

http://holobalance.eu

HOLOBalance study website

Other Identifiers

76957

Identifier Type: -

Identifier Source: org_study_id