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

Primary Purpose

Accidental Falls, Aging, Vestibular Disorder

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
HOLOBalance
OTAGO Home Exercise Programme
Sponsored by
King's College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Accidental Falls focused on measuring Rehabilitation, Tele-rehabilitation, Physical Therapy, Coaching, Physical Activity

Eligibility Criteria

65 Years - 80 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • King's College LondonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HOLOBalance

OTAGO Home Exercise Programme

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Acceptability Assessment 1: Recruitment Rate
Assessment of recruitment rate of study (% of eligible participants enrolled)
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).
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).
Acceptability 4: Qualitative interview
Acceptability of HOLOBalance to older adults will be investigated via exit interviews performed within the tele-rehabilitation intervention arm.
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).
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.

Secondary Outcome Measures

Balance Function Assessment
Functional Gait Assessment. This is a 10-item test that assesses performance on complex gait tasks (e.g. walking with head turns or stopping and turning). Each item is rated on a 4 point scale (0-3) with higher scores indicating better task performance.
Balance Function Assessment
Mini-BESTest. This is a 14-item test that assesses dynamic balance components including anticipatory postural adjustments, reactive postural control, sensory orientation and dynamic gait. The 14 items are scored on a 3 point scale (0-2), with a maximum score of 28 points awarded. Higher scores indicate better task performance.
Cognitive Function Assessment
Montreal Cognitive Assessment. This test includes sections on visuospatial/executive function (alternating trail-making, cube copy, clock drawing), naming (lion, rhinoceros, camel), attention (forward and backward digit span, tapping to the letter A, subtracting 7s from 100), language (sentence repetition, letter fluency), abstraction (similarities between train and bicycle, watch and ruler), memory (delayed verbal recall of 5 words) and orientation to time and place (6 questions)
Cognitive Function Assessment
Cambridge Neuropsychological Test Automated Battery (CANTAB). The test battery includes: (i) Motor screening task to assess a participant's general ability to understand and complete tasks and highlights if any sensorimotor or hearing impairments will have an impact on test performance, (ii) Paired Associated Learning assesses visual associative learning and memory, (iii) Spatial Working Memory to assess one's ability to retain and use visuospatial input, (iv) Reaction Time tests a person's mental and motor response speed, (v) Rapid Visual Information Processing assesses the ability to maintain visual attention and continuous performance on a task and (vi) Delayed Matching to Sample tests visual recognition memory and short term visual memory.
Subjective Questionnaire
Rapid Assessment of Physical Activity (RAPA). This is a 9-item, self-administered questionnaire developed to provide an easily administered and interpreted means of assessing levels of physical activity among adults older than 50 years. RAPA evaluates a wide range of physical activity level, from sedentary to vigorous activity, as well as strength and flexibility training
Subjective Questionnaire
WHO Disability Assessment Schedule 2.0. This is an assessment which provides a global measure of disability. It covers the following domains of functioning: Cognition - understanding & communicating; Mobility- moving & getting around; Self-care- hygiene, dressing, eating & staying alone; Getting along- interacting with other people; Life activities- domestic responsibilities, leisure, work & school; Participation- joining in community activities.
Subjective Questionnaire
Activities-Specific Balance Confidence Scale (ABC). This questionnaire assesses patients perceived confidence for performing 16-activities of daily living without losing balance. Scores ≤67/100% indicate increased falls risk.
Subjective Questionnaire
Falls Self-Efficacy Scale International. This is a short, easy to administer tool measuring an individual's level of concern regarding falling during social and physical activities inside and outside the home, whether or not the person actually does the activity. Level of concern is measured on a four-point Likert scale (1=not at all to 4=very). It has excellent internal validity and test-retest reliability. Scores of >23 for the long form and >10 for the short form have been suggested as cut points for indicating high concern about falling
Subjective Questionnaire
Behavioral Regulation in Exercise Questionnaire (BREQ-3). This is a 24 item questionnaire to assess motivation to exercise. Participants rate whether statements apply to themselves (or not) using a 5 point likertLikert scale ranging from 0 (Not true for me) to 4 (Very true for me)
Subjective Questionnaire
EQ-5D-5L. This is a standardized, valid and reliable simple, generic measure of health status for clinical and economic appraisal. The EQ-5D-5L has 5 dimensions (mobility, selfcare, usual activities, pain/discomfort, anxiety/depression) and includes the EQ visual Analogue scale (EQ VAS). The respondent is asked to rate their health status on these five dimensions from 1 to 5 respectively as no problems, slight problems, moderate problems, severe problems, and extreme problems. The EQ VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labeledlabelled 'the best health you can imagine' and 'the worst health you can imagine'. The respondent is asked to mark an X on the scale to indicate "how your health is TODAY".
Subjective Questionnaire
Environmental Mobility Scale. This is a self-report scale assessing the effect of the physical environment on community mobility. Twenty-four features of the physical environment are identified. For each feature, an encounter question (How often do you?) is paired with an avoidance question (How often do you avoid?). Subjects report on frequency of encounter and avoidance behaviour using a five-point ordinal scale (never, rarely, sometimes, often, always). The test-retest reliability of the questionnaire is good.

Full Information

First Posted
July 26, 2019
Last Updated
September 1, 2020
Sponsor
King's College London
Collaborators
University College, London, Horizon 2020 - European Commission, University of Ioannina, Roessingh Research and Development, University of Athens, University Hospital Freiburg
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1. Study Identification

Unique Protocol Identification Number
NCT04053829
Brief Title
Feasibility and Acceptability of HOLOBalance Compared to Standard Care in Older Adults at Risk for Falls
Acronym
HOLOBALANCE
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

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 2020 (Anticipated)
Primary Completion Date
April 2021 (Anticipated)
Study Completion Date
April 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College London
Collaborators
University College, London, Horizon 2020 - European Commission, University of Ioannina, Roessingh Research and Development, University of Athens, University Hospital Freiburg

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Accidental Falls, Aging, Vestibular Disorder
Keywords
Rehabilitation, Tele-rehabilitation, Physical Therapy, Coaching, Physical Activity

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Masking Description
Only the outcome assessor will be masked in this study
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HOLOBalance
Arm Type
Experimental
Arm Description
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.
Arm Title
OTAGO Home Exercise Programme
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
HOLOBalance
Intervention Description
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
Other
Intervention Name(s)
OTAGO Home Exercise Programme
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acceptability Assessment 1: Recruitment Rate
Description
Assessment of recruitment rate of study (% of eligible participants enrolled)
Time Frame
Through study completion (12 months)
Title
Acceptability Assessment 2: Programme Compliance
Description
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).
Time Frame
Through study completion (12 months)
Title
Acceptability Assessment 3: Drop out rate
Description
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).
Time Frame
Through study completion (12 months)
Title
Acceptability 4: Qualitative interview
Description
Acceptability of HOLOBalance to older adults will be investigated via exit interviews performed within the tele-rehabilitation intervention arm.
Time Frame
Collected at end of each participants participation in the study (After 8 weeks)
Title
Feasibility of providing HOLOBalance 1: Monitoring of Adverse and Serious Adverse Events
Description
Feasibility will be assessed by documenting adverse events (and SAE's) and adverse device effects (and SADE's).
Time Frame
Through study completion (12 months)
Title
Feasibility of providing HOLOBalance 2: Monitoring for deviations from study protocol
Description
Assessment of any deviations from protocol reported logged in the site files using the deviation from protocol form.
Time Frame
Through study completion (12 months)
Secondary Outcome Measure Information:
Title
Balance Function Assessment
Description
Functional Gait Assessment. This is a 10-item test that assesses performance on complex gait tasks (e.g. walking with head turns or stopping and turning). Each item is rated on a 4 point scale (0-3) with higher scores indicating better task performance.
Time Frame
Baseline (Week 0) and Follow up (Week 9)
Title
Balance Function Assessment
Description
Mini-BESTest. This is a 14-item test that assesses dynamic balance components including anticipatory postural adjustments, reactive postural control, sensory orientation and dynamic gait. The 14 items are scored on a 3 point scale (0-2), with a maximum score of 28 points awarded. Higher scores indicate better task performance.
Time Frame
Baseline (Week 0) and Follow up (Week 9)
Title
Cognitive Function Assessment
Description
Montreal Cognitive Assessment. This test includes sections on visuospatial/executive function (alternating trail-making, cube copy, clock drawing), naming (lion, rhinoceros, camel), attention (forward and backward digit span, tapping to the letter A, subtracting 7s from 100), language (sentence repetition, letter fluency), abstraction (similarities between train and bicycle, watch and ruler), memory (delayed verbal recall of 5 words) and orientation to time and place (6 questions)
Time Frame
Baseline (Week 0) and Follow up (Week 9)
Title
Cognitive Function Assessment
Description
Cambridge Neuropsychological Test Automated Battery (CANTAB). The test battery includes: (i) Motor screening task to assess a participant's general ability to understand and complete tasks and highlights if any sensorimotor or hearing impairments will have an impact on test performance, (ii) Paired Associated Learning assesses visual associative learning and memory, (iii) Spatial Working Memory to assess one's ability to retain and use visuospatial input, (iv) Reaction Time tests a person's mental and motor response speed, (v) Rapid Visual Information Processing assesses the ability to maintain visual attention and continuous performance on a task and (vi) Delayed Matching to Sample tests visual recognition memory and short term visual memory.
Time Frame
Baseline (Week 0) and Follow up (Week 9)
Title
Subjective Questionnaire
Description
Rapid Assessment of Physical Activity (RAPA). This is a 9-item, self-administered questionnaire developed to provide an easily administered and interpreted means of assessing levels of physical activity among adults older than 50 years. RAPA evaluates a wide range of physical activity level, from sedentary to vigorous activity, as well as strength and flexibility training
Time Frame
Baseline (Week 0) and Follow up (Week 9)
Title
Subjective Questionnaire
Description
WHO Disability Assessment Schedule 2.0. This is an assessment which provides a global measure of disability. It covers the following domains of functioning: Cognition - understanding & communicating; Mobility- moving & getting around; Self-care- hygiene, dressing, eating & staying alone; Getting along- interacting with other people; Life activities- domestic responsibilities, leisure, work & school; Participation- joining in community activities.
Time Frame
Baseline (Week 0) and Follow up (Week 9)
Title
Subjective Questionnaire
Description
Activities-Specific Balance Confidence Scale (ABC). This questionnaire assesses patients perceived confidence for performing 16-activities of daily living without losing balance. Scores ≤67/100% indicate increased falls risk.
Time Frame
Baseline (Week 0) and Follow up (Week 9)
Title
Subjective Questionnaire
Description
Falls Self-Efficacy Scale International. This is a short, easy to administer tool measuring an individual's level of concern regarding falling during social and physical activities inside and outside the home, whether or not the person actually does the activity. Level of concern is measured on a four-point Likert scale (1=not at all to 4=very). It has excellent internal validity and test-retest reliability. Scores of >23 for the long form and >10 for the short form have been suggested as cut points for indicating high concern about falling
Time Frame
Baseline (Week 0) and Follow up (Week 9)
Title
Subjective Questionnaire
Description
Behavioral Regulation in Exercise Questionnaire (BREQ-3). This is a 24 item questionnaire to assess motivation to exercise. Participants rate whether statements apply to themselves (or not) using a 5 point likertLikert scale ranging from 0 (Not true for me) to 4 (Very true for me)
Time Frame
Baseline (Week 0) and Follow up (Week 9)
Title
Subjective Questionnaire
Description
EQ-5D-5L. This is a standardized, valid and reliable simple, generic measure of health status for clinical and economic appraisal. The EQ-5D-5L has 5 dimensions (mobility, selfcare, usual activities, pain/discomfort, anxiety/depression) and includes the EQ visual Analogue scale (EQ VAS). The respondent is asked to rate their health status on these five dimensions from 1 to 5 respectively as no problems, slight problems, moderate problems, severe problems, and extreme problems. The EQ VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labeledlabelled 'the best health you can imagine' and 'the worst health you can imagine'. The respondent is asked to mark an X on the scale to indicate "how your health is TODAY".
Time Frame
Baseline (Week 0) and Follow up (Week 9)
Title
Subjective Questionnaire
Description
Environmental Mobility Scale. This is a self-report scale assessing the effect of the physical environment on community mobility. Twenty-four features of the physical environment are identified. For each feature, an encounter question (How often do you?) is paired with an avoidance question (How often do you avoid?). Subjects report on frequency of encounter and avoidance behaviour using a five-point ordinal scale (never, rarely, sometimes, often, always). The test-retest reliability of the questionnaire is good.
Time Frame
Baseline (Week 0) and Follow up (Week 9)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew Liston, PhD
Phone
+442078486316
Email
matthew.liston@kcl.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doris-Eva Bamiou, PhD
Organizational Affiliation
University College, London
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marousa Pavlou, PhD
Organizational Affiliation
King's College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
King's College London
City
London
ZIP/Postal Code
SE1 1UL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Liston, PhD
Phone
0207 848 6679
Email
matthew.liston@kcl.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Upon completion of all project outcomes and assessments for commercial exploitation.
IPD Sharing 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.
Citations:
PubMed Identifier
36044258
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.
Results Reference
derived
PubMed Identifier
33579762
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.
Results Reference
derived
Links:
URL
http://holobalance.eu
Description
HOLOBalance study website

Learn more about this trial

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

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