The UPBEAT Trial
Research type
Research Study
Full title
A randomised feasibility trial to evaluate a digital system for UPper limB rEhabilitation After sTroke - The UPBEAT Trial
IRAS ID
323576
Contact name
Ara Darzi
Contact email
Sponsor organisation
Imperial College London
Clinicaltrials.gov Identifier
PA4416, WorkTribe Ref Number
Duration of Study in the UK
0 years, 8 months, 26 days
Research summary
OnTrack™ is a rehabilitation system designed to help patients who have arm weakness following a stroke. The OnTrack™ system includes smart devices (smartphone and smartwatch), software (the OnTrack™ app) and coaching support. The OnTrack™ app (a Class I medical device which holds a current UKCA mark), in combination with the smart devices, are used to track arm movement. Motivational messages and a real-time display of completed arm activity (in minutes) are presented to the participant via the OnTrack™ app. Rehabilitation therapists can monitor their patients’ progress and adapt programs to an individual’s needs via a therapist facing software platform.
An existing study (Fusari et al. 2022) demonstrated OnTrack’s potential to improve patients’ experience and outcomes of arm rehabilitation. More robust evaluation of OnTrack is needed to further evaluate potential clinical benefits and cost effectiveness, as well as to inform how this intervention can be widely implemented.
UPBEAT is a randomised feasibility trial comparing OnTrack plus standard care versus standard care alone, for the rehabilitation of patients with arm weakness following a stroke. The trial will recruit two types of participants from up to five stroke rehabilitation services in hospital and community settings in England:
(i) Therapist participants who will deliver the trial intervention to patient participants.
(ii) Patient participants (n=42) who, if randomised to the intervention group, will be asked to utilise the OnTrack system for a 12 week period.All patient participants will be asked to complete assessments relating to arm weakness, arm function, participation, and quality of life at weeks 0, 6 and 12. Assessments can be completed online, over the telephone or face to face with a trial researcher.
Outcomes to be assessed relate to trial feasibility (recruitment, retention and assessment of outcome measures), and intervention feasibility (intervention fidelity, and acceptability to both patients and therapists).REC name
London - Surrey Research Ethics Committee
REC reference
23/PR/1251
Date of REC Opinion
13 Nov 2023
REC opinion
Favourable Opinion