Telerehabilitation of Balance Clinical and Economic Decision Support System
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 460
- 试验地点
- 7
- 主要终点
- Recruitment Rate (acceptability)
研究概览
简要总结
This study follows the successfully completed HOLOBalance project which was funded by the EU Horizon 2020 scheme. TheHOLOBalance platform delivers exercises demonstrated via a hologram of the physiotherapist and corrected in real time by the hologram prompts based on performance monitoring via sensors. Further information is available at: https://holobalance.eu/. HOLOBalance was developed as a comprehensive rehabilitation protocol for individualised remote (tele)rehabilitation balance physiotherapy programme. It includes different multisensory balance and gait exercises, physical activity and memory training and exergames (video games which are also exercises) to improve balance function in older adults. The system can thus assess and remotely monitor how users are performing the exercises.
This multisite randomised control trial (TeleRehab DSS, short for TeleRehabilitation Decision Support System) aims to (i) determine the system's safety, acceptability, and feasibility explore effectiveness of running such programme in comparison with the current standard care for middle-age/older adults with balance disorders/falls due to MCI, vestibular disorders, stroke or long Covid. This study also aims to (ii) assess if balance function, gait, cognitive function, balance confidence, and wellbeing can improve more compared to standard intervention and (iii) provide preliminary data for a definitive randomised controlled trial.
This study involves human participants, and each clinical site has applied for appropriate ethical approval.
详细描述
This is an assessor-blinded (researchers assessing the participants will not know what study group participants will be in), randomised (participants will join different study groups randomly) controlled study. Participants will be randomised using an online platform to undergo a home-based exercise programmes, into either the intervention group (IG) or control group (CG). Participants will not be able to choose their preferred group and must be willing to participate in the assigned group.
All study participants will attend two sessions at UCL. The first assessment will be within one week prior to starting the programme, and the second will be within one week of completing the programme. Participants will be asked to complete a questionnaire set, walking/balance tests and a cognitive test.
Participants will receive telephone calls each week to monitor their progress. Participants will also receive remote program reviews at weeks 3, 6 and 9, from a member of the research team to assess and change exercises as required. Participants will be advised to contact the research team by email or by telephone during working hours if they have concerns or questions about their rehabilitation program or the TeleRehab DSS system. The research team will judge whether an additional home visit is required. If a patient does not complete their exercises for three consecutive days, a flag/warning will appear on the patients dashboard as a priority patient to follow up with, within 24 hours.
Intervention Group (IG): TeleRehab DSS The intervention (TeleRehaB DSS) group participants will be visited by a research team member to install the TeleRehab DSS system in their home and taught how to use the system, with a practice session. The system comprises a depth camera, lightweight augmented reality headset that displays the hologram, body-worn sensors that record movements and a heart rate sensor. Participants will be required to wear all the equipment when performing the prescribed exercises. A demo-video (including equipment and hologram) is available at www.holobalance.eu. Exercise progressions will be suggested by the AI-supported TeleRehaB DSS and approved by the clinicians at weeks 3, 6, and 9, which will be loaded into the participant's programme. At the end of the study, participants will be invited to take part in an interview to discuss their experience with using the TeleRehab DSS system.
The IG will receive the TeleRehaB DSS supported, prescribed, progressed and delivered intervention. In the TeleRehaB DSS IG, the platform will suggest two possible management strategies, on an individualized basis, based on patient profiles and expected benefit: 1)The high-tech, full TeleRehaB DSS with all components of the intervention consisting of TeleRehaB DSS AI-progressed multisensory balance exercises with the use of the AR avatar, real time feedback, AR gamified intervention, sensor monitored exercise performance and additional cognitive training, 2) the low-tech, basic version of TeleRehaB DSS, with depth camera, sensors and tablet - multisensory balance exercises, real time feedback, sensor monitored exercise performance and cognitive games, with no exergames, no smartwatch, and no mobile phone. The clinician can override the TeleRehab DSS group allocation decision if it is deemed unsafe. The intervention will be delivered as a daily (5 days per week, 12 weeks long) home-based exercise programme prescribed by non-experts (junior physiotherapist without vestibular expertise or non physio) with DSS support and coaching.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Outcome assessors will be blinded to which study arm participants have been allocated to. Due to the nature of the study, investigator's and participants cannot be blinded, althouhg intervention group participants will be blinded as to which intervention (High vs. Low tech) they have been allocated to.
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40-80 years
- •community dwelling able to walk 500-m independently or with a stick
- •Depression subscale on Hospital Anxiety and Depression Scale <10/21 (14-item questionnaire)
- •No significant visual impairment (as self-reported by participants)
- •Willing to comply with study procedures, proposed training and testing regime
- •With capacity to consent
- •No acute musculoskeletal or other injuries that would prevent participation in a structured exercise program
- •Is not currently, and has not in the past 8-weeks received any falls/balance/vestibular and/or cognitive rehabilitation.
- •Does not any implanted medical devices or a cardiac pacemaker.
- •Does not have any other co-existing neurological conditions (ie. Multiple sclerosis, Parkinson's disease, neuropathy etc.)
- •Does not have any language or communication deficits impairing their ability to communicate and/or express their thoughts.
- •Has at least one functional hand for grip function and computer use.
- •Fulfilling all of the criteria from one of the below sub-groups
- •STROKE COHORT who will fulfil the additional criteria:
- •Individuals with diagnosis of focal ischaemic or haemorrhagic stroke, as confirmed by a clinical letter.
- •Onset >/= 3 months prior to study.
- •Montreal Cognitive Assessment (MoCA) score n >/=23
- •At risk of falls (i.e. Functional Gait Assessment FGA score </=22/30; FGA is a validated quick balance task assessment) AND/OR having experienced a fall(s) in the last 12 months
- •MCI COHORT who will fulfil the additional criteria:
- •Individuals with new or existing formal diagnosis of MCI, according to the International Classification of Disease 10 (ICD10) , as confirmed by a clinical letter.
- •At risk of falls (FGA </= 22/30) AND/OR having experienced a fall(s) in the last 12 months.
- •VESTIBULAR COHORT who will fulfill the additional criteria
- •Montreal Cognitive Assessment (MoCA) score n >/=23
- •Individuals with a diagnosis of a vestibular disorder (peripheral and/or mixed peripheral and central):
- •Peripheral vestibular disorder in which the balance problem lies in the vestibular/balance system within the inner ear.
- •Mixed vestibular disorder in which the balance problem lies in the vestibular/balance system within the inner ear (peripheral) and involving the nerves or neuronal network in the brain/brainstem responsible for balance (central).
- •Chronic dizziness and/or unsteadiness (>/= 3 months duration) that started at the time or after the vestibular disorder diagnosis.
- •Dizziness handicap inventory (DHI >34) AND/OR At risk of falls (FGA </=22/30)
- •LONG COVID-19 COHORT who will fulfill the additional criteria:
- •Montreal Cognitive Assessment (MoCA) score n >/=23
- •Individuals with laboratory confirmed diagnosis of Covid (>/=6 months prior to study onset), as confirmed by a clinical letter.
- •Who have been diagnosed with long Covid, as confirmed by a clinical letter.
- •Who have chronic dizziness and/or unsteadiness which started after the Covid illness (self-report by the patient; duration </=3 months).
- •Dizziness handicap inventory (DHI >34) AND/OR At risk of falls (FGA </=22/30)
排除标准
- •Outside of the stated age bracket
- •Unable to walk independently (even with use of a walking stick)
- •MOCA score <23
- •Score of 10 or higher on depression subscale of HADS
- •Unwilling to comply with study procedures, proposed training and testing regime
- •No capacity to consent
- •Significant visual impairment or homonymous hemianopia (stroke cohort only) (self-reported)
- •Orthostatic hypotension or uncontrolled hypertension
- •Other neurological problem (e.g. Parkingson's disease, Multiple Sclerosis etc.)
- •Language and communication deficits impairing ability to express thoughts (e.g. Aphasia)
- •Has participated in a clinical drug trial in the past 6 months.
- •Acute musculoskeletal injury that prevents participation in a structured exercise programme (e.g. lower limb fracture).
- •Has an implanted medical device or cardiac pacemaker.
- •Diagnosis of unstable Meniere's or with more than 4 migraines/month at the time of participating in the study
- •Not fulfilling the inclusion criteria for one of the sub-groups (such as criteria for Stroke group, or MCI group, or chronic vestibular disorder group, or long-Covid group), as outlined above.
- •Unable to provide a clinical letter confirming diagnosis.
- •For those with stroke, no visual spatial neglect.
结局指标
主要结局
Recruitment Rate (acceptability)
时间窗: Baseline (week 0) through to post-intervention at week 10
percentage of recruited participants that were eligible
Incidence of Treatment-Emergent Adverse Events (safety)
时间窗: Baseline (week 0) through to post-intervention at week 10
Participants will be monitored for adverse events during telephone or face-to-face contacts as part of the intervention phase and during follow-up assessments. Any adverse events related to the treatment will be reported via an adverse events form on the system database. Falls diaries will be collected weekly from participants during the intervention and monthly for up to 6 months after completion of the intervention.
Feasibility (protocol deviations/problems)
时间窗: Baseline (Week 0) through to post-intervention at week 10
Incidence of protocol deviation and/or implementation problems reported during the intervention.
Participants experience using the system (usability)
时间窗: weekly and post-intervention at week 10
Participants experience using the system (perceived benefits) via via weekly check in on frustration levels, technical troubleshooting and any other usability considerations, as well as during exit interviews for all TeleRehab DSS group completers.
Adherence to Intervention
时间窗: Week 1 through to completion at week 9
percentage of prescribed sessions completed throughout the intervention
Drop-out rate (acceptability)
时间窗: Baseline (week 0) through to post-intervention at week 10
Percentage of enrolled participants that were loss to follow-up or drop-outs
次要结局
- Mini Balance Evaluation Systems Test (Mini-BESTest)(Baseline (week 0) & post intervention (Week 10))
- Incremental cost-effectiveness ratio (ICER)(1 year before study to 1 year after the end of the intervention)
- Montreal Cognitive Assessment (MoCA)(Baseline (week 0) & post intervention (Week 10))
- Functional Gait Assessment (FGA)(Baseline (week 0) & post intervention (Week 10))
- EuroQol five dimensional descriptive system (EQ-5D-5L)(Baseline (week 0) & post intervention (Week 10))
- Rapid Assessment of Physical Activity (RAPA)(Baseline (week 0) & post-intervention (Week 10))
- Dizziness Handicap Inventory (DHI)(Baseline (week 0) & post intervention (Week 10))
- The Activities-specific balance confidence scale (ABC)(Baseline (week 0) & post intervention (Week 10))
- The Hospital Anxiety and Depression Scale (HADS-d) depression subscale(Baseline (week 0) & post intervention (Week 10))
- Fatigue Severity Scale (FFS)(Baseline (week 0) & post intervention (Week 10))
- Warwick-Edingburgh Mental Wellbeing Scale (WEMWBS)(Baseline (week 0) & post intervention (Week 10))
- Situational Vertigo Questionnaire(SVQ):(Baseline (week 0) & post intervention (Week 10))
- The system Usability Scale (SUS)(post-intervention (week 10))
- User experience questionnaire (UEQ)(Baseline (week 0), Week 8 & post intervention (Week 10))
- Falls(collected weekly for the duration of the 9-week intervention and up to 6 months after completing the intervention)
- System performance(post-intervention (week 10))
- eHealth Literacy Assessment (eHEALS)(Baseline (week 0))
- The Senior technology acceptance & adoption model (STAM)(Baseline (week 0))
- Mobile Device Proficiency Questionnaire - short (MDPQ-s)(Baseline (week 0))