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

Stroke Clinical Trial

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

Status Not yet recruiting

Clinical Trial 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.

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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Stroke

• NCT number: NCT03143478
• Study type: Interventional
• Source: University of Southampton
• Contact: Claire Meagher
• Phone: 442380595305
• Email: c.meagher@soton.ac.uk
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2017
• Completion date: November 1, 2017