Clinical Feasibility of M-Mark
Research type
Research Study
Full title
Mechanical Muscle Activity with Real-time Kinematics (M-MARK): A novel combination of existing technologies to improve arm recovery following stroke: phase 2 clinical feasibility study\n
IRAS ID
222076
Contact name
Ruth Turk
Contact email
Sponsor organisation
University of Southampton
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 4 months, 31 days
Research summary
About 150,000 people in the UK suffer a stroke each year and ~60% with moderate to severe stroke fail to recover arm or hand use. Stroke rehabilitation is increasingly home-based following early supported discharge (ESD) from hospital to facilitate self-management and avoid problems associated with prolonged hospital stays. There is strong evidence that intensive practice and re-education of normal movement is essential for functional motor recovery, hence the NHS guideline of 45 minutes therapy 5 days per week, but NHS Trusts have difficulty meeting this target due to cost and access to specialist therapists.\n\nAn M-MARK Mk1 device that combines an Inertial Measurement Unit (IMU) with an Mechanomyography (MMG) sensor has been designed and laboratory tested. Novel signal processing techniques have been demonstrated that reduce problems of vibration artifacts and generate information on mechanical muscle activity and movement. The aim of the overall M-MARK project is to develop a low-cost wearable wireless device (Mk2) that patients can use independently at home while practicing standardised everyday activities to regain upper limb function. Mk2 M-MARK has now been developed in collaboration with therapists, patients and their carers. The system incorporates feedback, presented on a computer/tablet, as motivating visualisations of movement showing them if they have moved in the correct way. A separate interface has been developed for therapists, which offers a simple system to diagnose specific movement problems to inform clinical decision-making, monitor progress and thus increase efficiency of therapy.\n\nIn phase 1 of this study user requirements were assessed to inform the development of the Mk2 M-MARK for clinical use. Ten patients and carers were interviewed and 20 health professionals took part in two focus groups, from Portsmouth Hospitals NHS trust and North Bristol NHS Trust. The final system has now been developed, reliability demonstrated and iterative testing with stroke patients has ensured usability of the system. \n\nThis phase of research will examine the clinical feasibility of using Mk2 M-MARK with stroke patients who are undergoing early supported discharge. All feasibility aspects of the wearable system will be assessed including usability and safety. Preliminary data on efficacy will be collected and a health economics analysis will be undertaken\n
REC name
South West - Frenchay Research Ethics Committee
REC reference
17/SW/0112
Date of REC Opinion
28 Jun 2017
REC opinion
Favourable Opinion