Investigating the feasibility and acceptability of the TeleRehabilitation of balance clinical and economic Decision Support System (TeleRehaB DSS) in adults at risk of falls: study protocol for a multicentre clinical trial
Brooke Nairn, Isabelle D Walz, Christos Nikitas, Diego Kaski, Nattawan Utoomprurkporn, Christoph Maurer, Dimitris Kikidis, Vassilis Tsakanikas, Dimitrios Fotiadis, Marousa Pavlou, Doris-Eva BamiouIntroduction
Falls are a significant concern for older adults, particularly those with neurological, vestibular, cognitive and post-viral conditions, due to dizziness and imbalance. Conventional balance rehabilitation programmes, though effective, face challenges in adherence and accessibility. The TeleRehabilitation Decision Support System (TeleRehaB DSS) uses artificial intelligence (AI) and motion tracking to provide individualised multisensory balance rehabilitation (MBR) remotely. This trial aims to evaluate the acceptability, feasibility, safety and preliminary efficacy of a home-based TeleRehaB DSS among community-dwelling older adults at risk of falls due to stroke, mild cognitive impairment (MCI), long COVID and vestibular dysfunction.
Methods and analysis
This multicentre, assessor-blinded randomised controlled trial will recruit 460 community-dwelling adults aged 40–80 years with stroke, MCI, vestibular dysfunction or long covid across five sites in the UK, Europe and Southeast Asia. Participants will be randomised to a 9-week remotely supervised home exercise programme using either TeleRehaB DSS (high-tech or low-tech MBR with exergames and cognitive training) or standard care (OTAGO home exercise programme or Meniere’s Dizziness booklet). Primary outcomes include feasibility, acceptability and safety, alongside clinical measures of balance and health-related quality of life (Functional Gait Assessment, EuroQol five-dimensional descriptive system instrument). Secondary outcomes assess balance, cognition, physical activity, dizziness, psychological well-being, fatigue and confidence. Usability, user experience and digital health literacy will also be evaluated. Anonymised data will undergo quality checks and be analysed using descriptive and exploratory statistics, mixed-effects models, cost-effectiveness analysis (incremental cost-effectiveness ratio) and thematic analysis of qualitative interviews, adjusting for site and relevant confounders.
Ethics and dissemination
This study has received institutional ethical approvals in the UK, Germany, Greece and Thailand and from Madeira, Portugal. Findings from this study will be submitted for peer-reviewed publications.
Trial registration number