Telerehabilitation Decision Support System: Pilot Testing Protocol

A vizsgálat adatai

Ki végzi

University College, London

Azonosító

NCT07079787

A regiszteradat frissítve

2025. július 23.

Eredeti leírás

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.A teljes eredeti leírásKevesebb

Telerehabilitation of Balance Clinical and Economic Decision Support System

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 pilot testing of a multisite randomised control trial (TeleRehab DSS, short for TeleRehabilitation Decision Support System) aims to investigating the usability and feasibility among a smaller sample population at each clinical site, identifying any technical bugs, and/or clinical procedural flaws to be remedied before delivery of the full-scale RCT.

Kizáró feltételek: Has participated in a clinical drug trial in the past 6 months; 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.); Has an implanted medical device or cardiac pacemaker; 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; For those with stroke, no visual spatial neglect; 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; Language and communication deficits impairing ability to express thoughts (e.g. Aphasia); Acute musculoskeletal injury that prevents participation in a structured exercise programme (e.g. lower limb fracture); Diagnosis of unstable Meniere's or with more than 4 migraines/month at the time of participating in the study; Unable to provide a clinical letter confirming diagnosis.

ALL PARTICIPANT Inclusion Criteria:; 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).

ClinicalTrials.gov NCT07079787