AzTrials
AzTrials

Hemiparesis of the Upper Limb Following StrokeNCT02266836

MyndMove Therapy for Severe Hemiparesis of the Upper Limb Following Stroke

A study testing MyndMove in people with Hemiparesis of the Upper Limb Following Stroke, run by MyndTec Inc. at 6 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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
What is being tested?
MyndMove
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
6 sitesCanada
Study dates
Oct 2014to Oct 2015
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
Show all 10Show fewer
  • 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
Show all 13Show fewer
  • 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

6 sites in 1 country.

6 sites in 1 country

Canada6 sites

  • Study site

    Brampton, Ontario

  • Study site

    London, Ontario

  • Study site

    Oshawa, Ontario

  • Study site

    Ottawa, Ontario

  • Study site

    Toronto, Ontario

  • Study site

    Windsor, Ontario

Other trials in Canada

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
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 groups in NCT02266836
Study groupRoleWhat they receive
MyndMoveExperimentalThe 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.

  1. Change in 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 (4)

  1. Change in Functional Independence Measure and Self-Care Functional Independence Measure for the early subacute subjects

    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

  2. System Usability Scale

    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).

    Measured: An average of 5 weeks after therapy has begun

  3. All adverse events

    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.

    Measured: Baseline - An average of 5 weeks after therapy has begun

  4. Amplitudes to elicit muscle movement

    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.

    Measured: Throughout study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2014 (estimated)
  2. Study startOct 2014
  3. Primary completionOct 2015
  4. Study completionOct 2015

Resources

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
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02266836
Sponsor's protocol ID
MT-ST-2001
Status last verified
Aug 2019
First submitted
26 Sep 2014
Last updated
28 Jan 2020
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing MyndMove in people with Hemiparesis of the Upper Limb Following Stroke, run by MyndTec Inc. at 6 sites 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: finished, as of the sponsor's last update on 28 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in 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 NCT02266836.

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 28 Jan 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in