Még nem keres résztvevőt itt: ThaiföldFázis nélkül

Telerehabilitation of Balance Clinical and Economic Decision Support System

A legfontosabb adatok

Ki végzi: University College, London
Hol: Bangkok (Thaiföld)A helyszín megnézéseMég 4 másik országban, 4 helyszínen
Azonosító: NCT06534164
Állapot: Toborzás még nem indult
Résztvevők: 460 fő, tervezett
Kezdés: 2025. szept. 1.
Tervezett befejezés: 2026. aug. 31.
A vizsgálat típusa: Beavatkozással járó, 4 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
A vizsgált kezelések: Full/High Tech Telerehabilitation decision support system
Basic/Low Tech Telerehabilitation decision support system
OTAGO Home exercise program
Vestibular rehabilitation program
A regiszteradat frissítve: 2025. július 10.

Ki vehet részt

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

A vizsgálat 40 és 80 év közötti felnőtteket keres, akiknek egyensúlyproblémájuk van vagy elesnek stroke, enyhe kognitív zavar, egyensúlyszervi (belsőfül-) betegség vagy hosszú Covid miatt. Egy távoli egyensúlygyakorló programot vizsgálnak.

Életkor: 40 és 80 év között
Nem: Mindkét nem részt vehet.
A betegség stádiuma: Négy csoport egyike: 3 hónapnál régebbi stroke, enyhe kognitív zavar, tartós egyensúlyszervi betegség vagy hosszú Covid. Mindegyikhez orvosi igazolás kell a diagnózisról, és elesési kockázat (FGA pontszám 22/30 vagy kevesebb) vagy elesés az elmúlt 12 hónapban. Az egyensúlyszervi és a hosszú Covid csoportban a 34 feletti Dizziness Handicap Inventory pontszám is elég.
Korábbi kezelés: Jelenleg és az elmúlt 8 hétben nem kapott elesés-, egyensúly-, egyensúlyszervi vagy kognitív rehabilitációt. Az elmúlt 6 hónapban nem vett részt gyógyszeres klinikai vizsgálatban.
Biomarker vagy leletérték: A stroke, az egyensúlyszervi és a hosszú Covid csoportban a MoCA pontszám legalább 23. A HADS kérdőíven a depresszió pontszám 10 alatt van.

A részvétel fő kizáró okai

Nem tud 500 métert gyalogolni, egyedül vagy bottal
Beültetett orvosi eszköz vagy szívritmusszabályozó
Más idegrendszeri betegség, például Parkinson-kór vagy sclerosis multiplex
Ortosztatikus hipotónia vagy nem beállított magas vérnyomás
Jelentős látáskárosodás vagy beszédprobléma, amely akadályozza a kommunikációt

A regiszter feltételei, szó szerint

Mind a 48 feltétel megnézéseKevesebb

Ki nem vehet részt

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

Egyéb feltételek

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)

Nézd meg, megfelelhetsz-e

Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.

40 és 80 év között vagy?

Helyszínek itt: Thaiföld

Még 4 másik országban, 4 helyszínen

King Chulalongeorn Memorial Hospital (KMCH)Bangkok, ThaiföldContact: Nattawan Utoomprurkporn, PhDNo longer taking part

A vizsgálatról

Mit akar kideríteni a vizsgálat

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

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.

A vizsgálat 4 csoportja

Full/High-tech TeleRehab DSSA vizsgált kezelés
5x/week x 9 weeks All TeleRehab DSS components: multisensory balance exercises, AR avatar, real-time feedback, AR gamified activities, sensor-monitored exercise performance and additional cognitive training.
Kezelés: Full/High Tech Telerehabilitation decision support system
Basic/Low-tech TeleRehab DSSA vizsgált kezelés
5x/week x 9 weeks With depth camera, motion sensors and tablet for multisensory balance exercises, real time feedback, sensor monitored exercise performance and cognitive games. No exergames, no smartwatch, no mobile phone.
Kezelés: Basic/Low Tech Telerehabilitation decision support system
OTAGO Home Exercise programmeMár használt kezelés, összehasonlításként
9-week balance exercise programme developed by a research group at University of Otago, New Zealand \[12\]. The OTAGO HEP will be provided to all individuals in the control arm who report falls/are at risk of falls. The OTAGO group participants will receive a pamphlet with instructions for home exercises within the programme, resistance bands and an exercise diary. The OTAGO HEP booklet is available at https://www.livestronger.org.nz/assets/Uploads/acc1162-otago-exercise-manual.pdf
Kezelés: OTAGO Home exercise program
Vestibular rehabilitation programmeMár használt kezelés, összehasonlításként
Daily x 9 weeks For participants with problems chronic (lasting \>3 months) dizziness/imbalance due to chronic vestibular disorder (affecting the vestibular /balance system) or due to long Covid). The vestibular rehabilitation group participants will receive a booklet with vestibular exercises which have been individualised based on the assessment by the research team member. The exercise booklet is a validated and widely used intervention for vestibular disorder \[17\]. This will be provided to all individuals in the control arm with chronic dizziness/imbalance (\>3 months) without falls/risk of falls (FGA\>22). The booklet has descriptions and diagrams of the exercises and instructions on how to progress these as well as an exercise log, available at: https://www.menieres.org.uk/files/pdfs/balance-retraining-2012.pdf
Kezelés: Vestibular rehabilitation program