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

Primary Purpose

Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
M-MARK
Sponsored by
University of Southampton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    M-MARK

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    Movement and muscle activity parameters measured by the M-MARK system
    Kinematic and Muscle activity data recorded within the system

    Secondary Outcome Measures

    Streamlined Wolf Motor Function Test
    Valid and reliable upper limb functional assessment

    Full Information

    First Posted
    April 25, 2017
    Last Updated
    May 3, 2017
    Sponsor
    University of Southampton
    Collaborators
    National Institute for Health Research, United Kingdom, Imperial College London, Maddison Ltd, Tactiq Ltd, University of Maryland, North Bristol NHS Trust, Portsmouth Hospitals NHS Trust
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03143478
    Brief Title
    Mechanical Muscle Activity With Real-time Kinematics (M-MARK): A Novel Combination of Existing Technologies to Improve Arm Recovery Following Stroke
    Official Title
    Mechanical Muscle Activity With Real-time Kinematics (M-MARK): A Novel Combination of Existing Technologies to Improve Arm Recovery Following Stroke
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 1, 2017 (Anticipated)
    Primary Completion Date
    November 1, 2017 (Anticipated)
    Study Completion Date
    November 1, 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Southampton
    Collaborators
    National Institute for Health Research, United Kingdom, Imperial College London, Maddison Ltd, Tactiq Ltd, University of Maryland, North Bristol NHS Trust, Portsmouth Hospitals NHS Trust

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke

    7. Study Design

    Primary Purpose
    Device Feasibility
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    M-MARK
    Arm Type
    Experimental
    Arm Description
    Participants self administer rehabilitation exercises using the M-MARK device for 20 days.
    Intervention Type
    Device
    Intervention Name(s)
    M-MARK
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Movement and muscle activity parameters measured by the M-MARK system
    Description
    Kinematic and Muscle activity data recorded within the system
    Time Frame
    Baseline - 4 weeks
    Secondary Outcome Measure Information:
    Title
    Streamlined Wolf Motor Function Test
    Description
    Valid and reliable upper limb functional assessment
    Time Frame
    Baseline - 4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Claire Meagher
    Phone
    442380595305
    Email
    c.meagher@soton.ac.uk
    First Name & Middle Initial & Last Name or Official Title & Degree
    Alex Pordage
    Phone
    44238059 5278
    Email
    A.Pordage@soton.ac.uk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jane Burridge
    Organizational Affiliation
    University of Southampton
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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