Feasibility and Acceptability of HOLOBalance Compared to Standard Care in Older Adults at Risk for Falls
HOLOBALANCE
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
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 26, 2019
CompletedFirst Posted
Study publicly available on registry
August 13, 2019
CompletedStudy Start
First participant enrolled
September 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2021
CompletedSeptember 2, 2020
August 1, 2020
7 months
July 26, 2019
September 1, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Acceptability Assessment 1: Recruitment Rate
Assessment of recruitment rate of study (% of eligible participants enrolled)
Through study completion (12 months)
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)
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)
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)
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)
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 Outcomes (11)
Balance Function Assessment
Baseline (Week 0) and Follow up (Week 9)
Balance Function Assessment
Baseline (Week 0) and Follow up (Week 9)
Cognitive Function Assessment
Baseline (Week 0) and Follow up (Week 9)
Cognitive Function Assessment
Baseline (Week 0) and Follow up (Week 9)
Subjective Questionnaire
Baseline (Week 0) and Follow up (Week 9)
- +6 more secondary outcomes
Study Arms (2)
HOLOBalance
EXPERIMENTALThe 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.
OTAGO Home Exercise Programme
ACTIVE COMPARATORThe 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
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- King's College Londonlead
- University College, Londoncollaborator
- Horizon 2020 - European Commissioncollaborator
- University of Ioanninacollaborator
- Roessingh Research and Developmentcollaborator
- University of Athenscollaborator
- University Hospital Freiburgcollaborator
Study Sites (1)
King's College London
London, SE1 1UL, United Kingdom
Related Publications (2)
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.
PMID: 36044258DERIVEDListon 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.
PMID: 33579762DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Doris-Eva Bamiou, PhD
University College, London
- PRINCIPAL INVESTIGATOR
Marousa Pavlou, PhD
King's College London
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Only the outcome assessor will be masked in this study
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 26, 2019
First Posted
August 13, 2019
Study Start
September 1, 2020
Primary Completion
April 1, 2021
Study Completion
April 1, 2021
Last Updated
September 2, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Upon completion of all project outcomes and assessments for commercial exploitation.
- Access Criteria
- Sharing will be made possible only by the approval of the Holobalance data management board, and use and re-use of the pilot dataset will be subject to the license under which the data objects were deposited.
Electronic data will be anonymised and uploaded to a data repository that supports restricted access.Restricted access will be required for the data generated from the study participants.These files will not be made publicly available and sharing will be made possible only by the approval of the Holobalance data management board, and use and re-use of the pilot dataset will be subject to the license under which the data objects were deposited. Holobalance will also consider to deposit the content under an embargo status and provide an end date for the embargo in order to explore exploitation possibilities which affect the availability of data for third parties and usually is not finalized before the end of the project and the outcomes of the pilot study.