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Telerehabilitation of balance clinical and economic decision support system

Comparison of Treatment Outcomes between Telemedicine rehabilitation programme (TeleRehabDSS) and the paper-based for Fall Prevention

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20240917004
Enrollment
60
Registered
2024-09-17
Start date
2025-10-08
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

exercise rehabilitation vestibular falls artificial intelligence physiotherapy balance telerehabilitation cognitive Rehabilitation Balance Assessment Multifactorial Falls Vestibular Diseases Parkinson&#039

Interventions

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 inter
Remote initial session and follow-up phone call program reviews. - Lower limb muscle strength and balance assessment (chair stand test and the four-test balance scale) will not be performed as strengt
Experimental Device,Experimental Device,Active Comparator Procedure/Surgery,Active Comparator Procedure/Surgery
High-tech/TeleRehabDSS balance rehabilitation program,Low-tech/TeleRehabDSS balance rehabilitation program,OTAGO Home Exercise Programme (HEP),Vestibular rehabilitation programme

Sponsors

University College, London
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: All participant groups inclusion criteria: 1. Age 40-80 years 2. Community dwelling able to walk 500-m independently or with a stick 3. Depression Scale on Hospital Anxiety and Depression Scale should be less than 10/21 4. No significant visual impairment (as self-reported by participants) 5. Participants must show willing to comply with study and with capacity to consent. 5. No acute musculoskeletal or other injuries that would prevent participant in a structured exercise program. 6. Is not currently and has not received any falls/balance/vestibular and/or cognitive rehabilitation in the past 8-weeks. 7. Has not received a diagnosis of more than one of the study disease cohorts (Stroke, MCI, Vestibular Disorder) 8. Does not have any other co-existing neurological conditions (ie. Multiple sclerosis, Parkinson's disease, neuropathy etc.) 9. Does not have any language or communication deficits impairing their ability to communicate and/or express their thoughts 10. Has at least one functional hand for grip function and computer use. 9. Fulfilling all the criteria from one of the below sub-groups Inclusion criteria for Stroke: 1. Individuals with new/existing diagnosis of MCI (ICD 10 criteria) as confirmed by a clinical letter. 2. Onset > 6 months prior to study 3. Montreal Cognitive Assessment - MoCA score full version >= 23 (the Montreal Cognitive Assessment is a validated rapid screening test of language, memory, attention, visual/spatial, reasoning, orientation skills) 4. At risk of falls: FGA (Functional Gait Assessment) Score should be equal or less than 22/30 and/or having an episode of falling in the last 12 months 5. If diagnosed with a drop foot, they have a corrective device (AFO, FES etc.) in-place for exercise performance The stroke intervention group will receive TeleRehaB DSS; the Stroke control group will receive OTAGO HEP Inclusion criteria for MCI: 1. Individuals with new or existing formal diagnosis of MCI, according to the International Classification of Disease 10 (ICD10), as confirmed by a clinical letter. 2. At risk of falls: FGA (Functional Gait Assessment) Score should be equal or less than 22/30 and/or having an episode of falling in the last 12 months The MCI intervention group will receive TeleRehaB DSS; the MCI control group will receive OTAGO HEP. Inclusion criteria for Vestibular Disorders: 1. Individuals with diagnosis of a peripheral and/or mixed (peripheral and central) vestibular disorder as confirmed by a clinical letter: - 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). 2. Chronic dizziness and/or unsteadiness (self-report by the patient; duration >3 months) that started at the time or after the vestibular disorder diagnosis. 3. Montreal Cognitive Assessment - MoCA score full version >= 23 (the Montreal Cognitive Assessment is a validated rapid screening test of language, memory, attention, visual/spatial, reasoning, orientation skills) 4. Dizziness handicap inventory (DHI >34) AND/OR At risk of falls (FGA <22/30) The vestibular intervention group will receive TeleRehab DSS; the vestibular control group will receive vestibular

Exclusion criteria

Exclusion criteria: If a participant presents with any of the exclusion criteria throughout the onboarding and or intervention period, they will be withdrawn as deemed ineligible. - Outside of the stated age bracket. - Unable to walk independently even with use of a walking stick. - MoCA score less than 23 for Stroke and Vestibular dysfunction cohorts. - 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, or visual spatial neglect (stroke cohort only) (self-reported). - Uncontrolled hypertension. - Other neurological problem (for example, Parkinsons disease, Multiple Sclerosis, etc.). - Language and communication deficits impairing ability to express thoughts (for example, Aphasia). - Has participated in a clinical drug trial in the past 6 months. - Acute musculoskeletal injury that prevents participation in a structured exercise program (for example, lower limb fracture). - Has an implanted electrical medical device or cardiac pacemaker. - Diagnosis of unstable Menieres or with more than 4 migraines per month at the time of participating in the study. - Not fulfilling the inclusion criteria for one of the subgroups (such as criteria for Stroke group, or MCI group, or chronic vestibular disorder group, or long Covid group) as outlined above. - Has received a diagnosis of more than one of the study disease cohorts (Stroke, MCI, Vestibular Disorder, Long Covid). - Unable to provide a clinical letter confirming diagnosis.

Design outcomes

Primary

MeasureTime frame
EuroQol five dimensional descriptive system (EQ-5D-5L) Baseline (week 0) & end of intervention follow up (week 12) EuroQol five dimensional descriptive system (EQ-5D-5L),Functional Gait Assessment (FGA) Baseline (week 0) & end of intervention follow up (week 12) Functional Gait Assessment (FGA),Quality-Adjusted Life Years (QALYs) 1 year before the study and for 1 year after the end of intervention Quality-Adjusted Life Years (QALYs)

Secondary

MeasureTime frame
Balance & orientation assessment measures Baseline (week 0) & post intervention (week 14) Mini Balance Evaluation Systems Test (Mini-BESTest),Cognitive assessment measures Baseline (week 0) & post intervention (week 14) Montreal Cognitive Assessment (MoCA),Physical activity and social participation assessment Baseline (week 0), week 8 & post intervention (week 14) Rapid Assessment of Physical Activity (RAPA),Subjective questionnaires Baseline (week 0) & post intervention (week 14) Dizziness Handicap Inventory (DHI),Subjective questionnaires Baseline (week 0) & post intervention (week 14) The Activities-specific balance confidence scale (ABC),Subjective questionnaires Baseline (week 0) & post intervention (week 14) The Hospital Anxiety and Depression Scale (HADS-d) depression subscale,Subjective questionnaires Baseline (week 0) & post intervention (week 14) Warwick-Edingburgh Mental Wellbeing Scale (WEMWBS),Subjective questionnaires Baseline (week 0) & post intervention (week 14) Situational Characteristics Questionnaire (SCQ),System usability and experience Baseline (week 0) & post intervention (week 14) The system Usability Scale (SUS),System usability and experience Baseline (week 0), week 8 & post intervention (week 14) User experience questionnaire (UEQ),Falls collected weekly for duration of 12-week intervention and up to 12 months after completing the intervention Falls diary collected (self-reported),e-health literacy Baseline (week 0) & post intervention (week 14) eHealth Literacy Assessment (eHEALS),e-health literacy Baseline (week 0) & post intervention (week 14) The Senior technology acceptance & adoption model (STAM),e-health literacy Baseline (week 0) & post intervention (week 14) Mobile Device Proficiency Questionnaire - short (MDPQ-s)

Countries

Thailand

Contacts

Public ContactSun Reungpatana

Department of Otolaryngology

sun_reung@docchula.com0877090125

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026