Mechanical Muscle Activity With Real-time Kinematics (M-MARK): A Novel Combination of Existing Technologies to Improve Arm Recovery Following Stroke

Not yet recruiting

Phase N/A Results N/A

Trial Description

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.
An 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.
In 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 Mk2 system has now been developed, reliability demonstrated and iterative testing with stroke patients has ensured usability of the system.
This 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.

Conditions

Interventions

  • M-MARK Device
    Intervention Desc: M-MARK will be used by therapists for assessment of the upper limb, and stroke participants will be asked to use M-MARK whilst performing individually tailored and prescribed exercises for a minimum of 5 days/week. A set of tailored arm exercises using M-MARK (including targets for repetitive and functional activities) will be prescribed which the participant will be asked to practice independently at home for four weeks. During the four weeks, the patient (with support from their carer as required) will be encouraged to don the M-Mark garment and log-on to the M-Mark computer tablet each day to carry out their programme of exercises. They will be asked to use M-Mark to repeat as many exercise sessions per day as prescribed to them by their research therapist.
    ARM 1: Kind: Experimental
    Label: M-MARK
    Description: Participants self administer rehabilitation exercises using the M-MARK device for 20 days.

Outcomes

Type Measure Time Frame Safety Issue
Primary Movement and muscle activity parameters measured by the M-MARK system Baseline - 4 weeks
Secondary Streamlined Wolf Motor Function Test Baseline - 4 weeks

Sponsors