- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02266836
MyndMove Therapy for Severe Hemiparesis of the Upper Limb Following Stroke
Clinical Feasibility and Usability of MyndMove Therapy for FES Facilitated Treatment of Subacute and Chronic Severe Hemiparesis of the Upper Limb Following Stroke
Study Overview
Status
Intervention / Treatment
Detailed Description
The purpose of this study is to examine the efficacy of MyndMove therapy in the early sub-acute, late sub-acute and chronic post-stroke patients. Other objectives include assessing the required doses of electrical current amplitudes, the usability of the device, and examining the overall safety.
Many individuals experience weakness or paralysis of their arms and hands following a stroke. As a result, they are often unable to grasp and reach objects voluntarily and have difficulty performing basic activities of daily living (ADLs) such as dressing, feeding, bathing and grooming. Despite extensive rehabilitation programs, many of these individuals remain dependent on others for assistance with ADLs. This unmet medical need remains the focus of a wide range of research efforts.
MyndMove is a newly developed Functional Electrical Stimulation based treatment designed to recover voluntary movement in severely paralyzed upper limbs following stroke and spinal cord injury.
This study will enroll stroke patients that have severe hemiparesis of an upper limb (as defined by 1) an UE-FMA score of less than or equal to 19 and 2) a Chedoke McMaster Stage of 1-2 for the arm and hand). Three cohorts of patients enrolled in the study will include:
- Early sub-acute stroke patients (less than 2 months post stroke) receiving therapy during inpatient rehabilitation;
- Late sub-acute stroke patients (post-discharge from inpatient rehab and less than 6 months post stroke) receiving therapy in outpatient clinic settings; and
- Chronic stroke patients (greater than 6 months post stroke) receiving therapy in outpatient clinic settings
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Brampton, Ontario, Canada
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London, Ontario, Canada
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Oshawa, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Windsor, Ontario, Canada
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Ischemic or hemorrhagic stroke confirmed by MRI or CT scan
- Sub-acute subjects at least 10 days post stroke. Chronic subjects at least 6 months post stroke
- Chedoke-McMaster Stroke Assessment Stage 1-2 (arm and hand)
- Severe hemiplegia of the upper extremity defined as UE-FMA score of less than or equal to 19
- Subject is able to follow instructions
- Subject is able to sit and participate in one hour of upper limb therapy
- Anticipated to be discharged home or already at home following conventional inpatient rehabilitation
- Willing to attend outpatient therapy if chronic or late sub-acute
- Subject is able and willing to give written informed consent
- Men and women aged 18 or older
Exclusion Criteria:
- Global Aphasia
- Previous history of clinical stroke either ischemic infarct, hemorrhagic and subarachnoid bleeding
- Upper extremity injury or condition prior to stroke that limits the function of the hand or arm
- Life expectancy of less than 12 months due to other illness
- Subject has malignant skin lesion on the affected upper extremity
- Subject has history of seizure disorder and on seizure medications
- Subject has existing electrical stimulation devices (ICD, Pacemaker, Spinal Stimulation)
- Neurologic condition that may affect motor response (e.g. Parkinson's, ALS, MS)
- Subject has rash or open wound at any potential electrode site
- In the judgment of the medical provider, subject has medical complications that may interfere with the execution of the study
- Botulinum toxin (Botox) injection into affected upper extremity at least 3 months before the study or during the study
- Currently enrolled in another upper limb study
- Enrolled in the past six months in a clinical study involving drugs or biologics
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: MyndMove
The MyndMove system is a neuromodulation device that delivers short electrical pulses to stimulate muscle contractions and enhance motor recovery following Stroke or Spinal Cord Injury.
MyndMove delivers therapeutic stimulation sequences called protocols, which are coded therapeutic algorithms which assist muscle movement allowing the brain and central nervous system to be retrained restoring voluntary reaching and grasping functions lost following neurological injury.
The MyndMove system comprises the hardware device, stimulation electrodes and cables, hand and foot switches, and integrated software.
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During a MyndMove therapy session, the patient is instructed to attempt to execute a task voluntarily.
As the patient is attempting to perform the designated task, specific muscles in the arm are stimulated to generate contractions that produce the desired movement.
After a brief interval of the patient attempting to initiate a movement the therapist activates the MyndMove stimulation protocol, which generates bursts of short electrical pulses, using surface electrodes, to produce muscle contractions enabling the patient to complete the desired/instructed task.
Proper sequencing of the muscle contractions as per the MyndMove protocols are tailored to achieve a wide range of reaching and grasping functions.
The technique stimulates non-damaged pathways of the central nervous system.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change in Upper Extremity Fugl-Meyer Assessment (UE-FMA)
Time Frame: baseline to 6 weeks
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The Upper Extremity Fugl-Meyer Assessment (UE-FMA) is a standardized scale used for the evaluation of physical performance in the post-stroke hemiplegic patient.
The upper extremity (UE) evaluates the function of the upper extremity motor function in four components: Shoulder/Elbow and Forearm, Wrist, Hand and Coordination and Speed in a series of performed tasks.
The maximum score associated with the UE-FMA is 66 points.
Each of the 33 specific tasks is scored as either 0 or an absence of function to a maximum score of 2 for the tasks being fully completed.
Partial function can be scored as 1 for selected tasks.
This evaluation will be completed by a trained physiotherapist or occupational therapist.
Upper extremity assessment for stroke patients.
Clinically Significant change is >6 points
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baseline to 6 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change in Functional Independence Measure and Self-Care Functional Independence Measure for the early subacute subjects
Time Frame: Baseline - 6 weeks
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To measure the degree of disability the Functional Independence Measure will be completed.
The FIM consists of 18 items of which 13 are motor related tasks and 5 are cognitive related items.
The measure is broken down into 6 classifications of self-care, sphincter control, mobility, locomotion, communication and social cognition.
The self-care consists of 6 items: eating, grooming, bathing, dressing-upper body, dressing-lower body, toileting.
Each item is rated using a 7-point scale indicating the level of functioning from total assistance with a score of 1 to complete independence with a score of 7.
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Baseline - 6 weeks
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System Usability Scale
Time Frame: An average of 5 weeks after therapy has begun
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Each Therapist will complete the System Usability Scale on the last treatment visit which is expected to be an average of 5 weeks after therapy has begun.
Each question in the System Usability Scale is scored from 1 - Strongly Disagree, through to 5 - Strongly Agree.
System Usability Scale scores, based on therapist assessments, at end of study compared to baseline (after basic training).
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An average of 5 weeks after therapy has begun
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All adverse events
Time Frame: Baseline - An average of 5 weeks after therapy has begun
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At each study visit, participants will be asked if they have experienced any adverse events.
Participants will be in the study for an expected average of 5 weeks.
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Baseline - An average of 5 weeks after therapy has begun
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Amplitudes to elicit muscle movement
Time Frame: Throughout study
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The amplitudes that are used to elicit the muscle movement will be recorded for the various muscles for each participant.
The average required amplitude will be calculated and the minimum and maximum amplitudes will be noted.
This will provide future guidance on the typical range of amplitudes needed for the various muscles to treat patients.
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Throughout study
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mark Bayley, MD, University Health Network, Toronto
- Principal Investigator: Debbie A Hebert, MSc(Kin), University Health Network, Toronto
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MT-ST-2001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hemiparesis of the Upper Limb Following Stroke
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Shirley Ryan AbilityLabCoapt, LLCRecruitingLower Limb Amputation Below Knee (Injury) | Lower Limb Amputation Above Knee (Injury) | Amputation | Phantom Limb Pain | Phantom Pain | Phantom Sensation | Lower Limb Amputation Knee | Lower Limb Amputation at Ankle (Injury) | Upper Limb Amputation at the Hand | Upper Limb Amputation at the Wrist | Upper... and other conditionsUnited States
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Mansoura UniversityCompletedSurgery to the Distal One Third of the Upper LimbEgypt
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Istituti Clinici Scientifici Maugeri SpACompletedUpper Extremity Injury | Hemiplegia and/or Hemiparesis Following StrokeItaly
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Hospital Clínico Universitario de ValladolidHospital Clinic of Barcelona; Hospital de Basurto; Complejo Hospitalario de Navarra and other collaboratorsRecruitingPeriprosthetic Fractures | Periprosthetic Fracture of the Upper or Lower Limb | Peri-implant Fracture of the Upper or Lower Limb | Peri-implant FractureSpain
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Centre Hospitalier Universitaire DijonCompletedPatient Requiring Scheduled Conventional Orthopedic Surgical Intervention of the Upper or Lower LimbFrance
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Shirley Ryan AbilityLabEunice Kennedy Shriver National Institute of Child Health and Human Development...Active, not recruitingAmputation | Amputation; Traumatic, Limb | Upper Limb Amputation at the Hand | Upper Limb Amputation at the WristUnited States
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Azienda Ospedaliero, Universitaria PisanaScuola Superiore Sant'Anna di PisaRecruitingUpper Limb Amputation at the WristItaly
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Federal University of Espirito SantoEnrolling by invitationUpper Limb Amputation at the HandBrazil
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University of ManitobaRehabilitation Centre for Children, CanadaNot yet recruitingPediatric | Upper Limb Amputation at the Hand | Upper Limb Amputation at the Wrist | Upper Limb Amputation Below Elbow (Injury) | Upper Limb Amputation | Amniotic Band Syndrome
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Union de Gestion des Etablissements des Caisses...CompletedPatients With Musculoskeletal Disorders of the Upper Limb With Symptoms of ExclusionFrance
Clinical Trials on MyndMove
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University of British ColumbiaRick Hansen Institute; MyndTec Inc.TerminatedTraumatic Spinal Cord InjuriesCanada
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University Health Network, TorontoUnknown
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MyndTec Inc.United States Department of Defense; McMaster University; U.S. Army Medical Research... and other collaboratorsCompletedTrauma, Nervous System | Spinal Cord InjuriesUnited States, Canada
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Holland Bloorview Kids Rehabilitation HospitalMyndTec Inc.UnknownStroke | Hemiparesis