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
About this trial
This is an interventional device feasibility trial for Stroke
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.
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
NCT ID
NCT03143478
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
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
Learn more about this trial
Mechanical Muscle Activity With Real-time Kinematics (M-MARK): A Novel Combination of Existing Technologies to Improve Arm Recovery Following Stroke
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