StrokeNCT03323632
MyndMove Therapy for Severe Hemiparesis of the Upper Limb Following Stroke
A study testing MyndMove in people with Stroke, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- MyndMove
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2014to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Feasibility and Usability of MyndMove Therapy for FES Facilitated Treatment of Subacute and Chronic Severe Hemiparesis of the Upper Limb Following Stroke
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.
Read the 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
- Conditions
- Stroke
- Being tested
- MyndMove
- Keywords
- Stroke, Cerebrovascular accident, Upper extremity, Cerebral Infarction, Brain Infarction, Brain Ischemia, Cerebrovascular Disorders, Cardiovascular Diseases, Nervous System Diseases, Central Nervous System Diseases
- Medical subject headings
- Stroke, Cerebral Infarction, Brain Infarction, Brain Ischemia, Cerebrovascular Disorders, Cardiovascular Diseases, Nervous System Diseases, Central Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyndMoveDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| MyndMove | Experimental | 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. Receives: Device: MyndMove |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper Extremity Fugl-Meyer Assessment (UE-FMA)
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
Measured: baseline to 6 weeks
Secondary outcomes (1)
FIM and Self - Care FIM
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.
Measured: Baseline - 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2017
- Study startAug 2014
- Primary completion30 Sep 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Debbie A Hebert, MSc(Kin), Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03323632
- Sponsor's protocol ID
- MT ST-2001
- Other IDs
- 14-7505DE
- Status last verified
- Aug 2014
- First submitted
- 24 Oct 2017
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Hebert, D, Bowen, J. M., Ho, C. Antunes, I, O'Reilly, D. J. and Bayley, M. (2017) Examining a new functional electrical stimulation therapy with people with sever upper extremity hemiparesis and chronic stroke: A feasibility study. British Journal of Occupational Therapy. 0/0: 1 - 10.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Feasibility and Usability of MyndMove Therapy for FES Facilitated Treatment of Subacute and Chronic Severe Hemiparesis of the Upper Limb Following Stroke
- ClinicalTrials.gov ID
- NCT03323632
- Acronym / sponsor ID
- MT ST-2001
- Conditions
- Stroke
- Keywords
- Stroke, Cerebrovascular accident, Upper extremity, Cerebral Infarction, Brain Infarction, Brain Ischemia, Cerebrovascular Disorders, Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- 30 Sep 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 27 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MyndMove | Experimental | Device: MyndMoveThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyndMoveDuring 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. | Device | MyndMove |
Primary outcome
Upper Extremity Fugl-Meyer Assessment (UE-FMA)
Time frame: baseline to 6 weeks
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
1 secondary outcome
FIM and Self - Care FIM
Time frame: Baseline - 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
- BackgroundHebert, D, Bowen, J. M., Ho, C. Antunes, I, O'Reilly, D. J. and Bayley, M. (2017) Examining a new functional electrical stimulation therapy with people with sever upper extremity hemiparesis and chronic stroke: A feasibility study. British Journal of Occupational Therapy. 0/0: 1 - 10.
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Debbie A Hebert, MSc(Kin) principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyndMove in people with Stroke, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper Extremity Fugl-Meyer Assessment (UE-FMA) (time frame: baseline to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03323632, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2017.