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

NCT ID: NCT03143478

Last Updated: 2017-05-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2017-11-01

Brief 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.

Conditions

Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

M-MARK

Participants self administer rehabilitation exercises using the M-MARK device for 20 days.

Group Type: EXPERIMENTAL

M-MARK

Intervention Type: DEVICE

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.

Interventions

M-MARK

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Aged 18 years old or older.
• Between 1 and 20 weeks post clinical diagnosis of stroke with residual upper limb movement deficits.
• Currently undergoing upper limb rehabilitation post-stroke within early supported discharge.
• Be able to lift hemiparetic arm from lap onto a table.
• Physically and cognitively able to comply with study protocol (Score 19 or higher on the Montreal cognitive assessment [9] (scores between 19-25 corresponds to mild cognitive impairment, and 25-30 represent normal cognition). For aphasic patients, the Oxford cognitive screen (OCS) will be used to determine cognitive status.
• Able to walk to or transfer to a chair and bring it up to a table nearby, independently or have assistance of a carer as required.
• Able to effectively don and doff the garment independently or have a carer who is able and willing to assist them.
• Be medically stable enough to undergo arm rehabilitation, as determined by the ESD team.

Exclusion Criteria

• Unable to understand the purpose of the study, follow simple instructions and give informed consent
• Unable to provide useful feedback (either patient or carer) due to communication difficulties post stroke.
• A maximum level of arm function - full movement of the elbow, shoulder and hand with the only unresolved impairment being fine dexterity.
• Requirement of an interpreter.
• A skin disease or allergy to garment material including: Nylon, Polypropylene or Polyester.
• Severe pain of the hemiparetic arm, shoulder or hand, either at rest or during movement.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role: collaborator

Imperial College London

OTHER

Sponsor Role: collaborator

Maddison Ltd

OTHER

Sponsor Role: collaborator

Tactiq Ltd

UNKNOWN

Sponsor Role: collaborator

University of Maryland

OTHER

Sponsor Role: collaborator

North Bristol NHS Trust

OTHER

Sponsor Role: collaborator

Portsmouth Hospitals NHS Trust

OTHER_GOV

Sponsor Role: collaborator

University of Southampton

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jane Burridge

Role: PRINCIPAL_INVESTIGATOR

University of Southampton

Central Contacts

Claire Meagher

Role: CONTACT

c.meagher@soton.ac.uk

442380595305

Alex Pordage

Role: CONTACT

A.Pordage@soton.ac.uk

44238059 5278

Other Identifiers

01

Identifier Type: -

Identifier Source: org_study_id