Feasibility study of the OnTrack stroke rehabilitation system V1.0
Research type
Research Study
Full title
Feasibility study of OnTrack - a digital system for upper limb rehabilitation after stroke
IRAS ID
257058
Contact name
Ara Darzi
Contact email
Sponsor organisation
Imperial College London
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 3 months, 1 days
Research summary
Research Summary
Aims: Assess the feasibility of ‘OnTrack’ (a new arm rehabilitation system), for use by patients, and therapists in stroke rehabilitation services.
Background: Arm disability is a common problem after stroke, affecting 450,000 people in the UK. Arm disability (e.g. weakness) can lead to loss of independence. Repetitive activity is critical for recovery but research shows that people can struggle with knowing what or how much to do, and keeping track of their progress. We spent 18 months working with over 100 therapists and patients to develop a solution to this problem.
Intervention: The OnTrack system consists of smart-devices (smartphone and smartwatch) and therapist support. Smart-devices are used to track arm movement, receive motivational messages and provide a real-time display of completed arm activity. Therapist support is provided through fortnightly consultations. Additionally, OnTrack helps therapists understand more about how and when patients use their affected arm between treatments.Design and methods: A study assessing the feasibility of OnTrack for patients and therapists to use in hospital and/or community. We aim to recruit 24-38 participants from a stroke unit. Participants will be involved in the study for 14 weeks. During week 1, 8 and 14 participants will complete assessments. During weeks 2-13 participants will use OnTrack to receive daily motivational messages, and consultations from OnTrack therapists to address problems and gain feedback. Participants will be loaned equipment needed for the study.
Patient and public involvement: We have a steering group of 4 stroke patients helping develop patient facing documentation and refining key messages developed from interview data. They are members of the research team and will be reimbursed for their time and travel, according to INVOLVE guidance.
Dissemination: Results of the study will be written-up for academic publications and also compiled into reports for patients and therapists.Summary of Results
The OnTrack intervention was found to be usable and acceptable by participants; objectives were met and demonstrated that a definitive trial would be feasible and acceptable.
181 individuals were screened, 24 recruited, 12 completed the intervention. Recruitment, retention and completion rates were in line with pre-study expectations and acceptable for a definitive trial. Participants felt the study requirements were acceptable and the intervention usable. Fidelity of delivery was acceptable according to predetermined fidelity markers. Sample size estimates and primary outcomes for a definitive trial were identified.REC name
London - Surrey Research Ethics Committee
REC reference
19/LO/0881
Date of REC Opinion
19 Jun 2019
REC opinion
Favourable Opinion