Introduction to MyndMove Therapy Clinical Studies
Feasibility and usability of MyndMove for treatment of subacute and chronic severe Hemiparesis (weakness or paralysis to one side of the body) of the upper limb following stroke.
MyndMove is a non-invasive medical device that uses short, low energy electrical pulses delivered by electrodes placed on the skin to cause controlled and well-coordinated muscle contractions. The MyndMove system is designed to help stroke and spinal cord injury (SCI) patients by allowing occupational therapists and physiotherapists to create coordinated reaching and grasping movements in the paralyzed arm(s), hand(s), and/or finger(s). Patients move their arm(s), hand(s), and/or finger(s) as they try carry out typical reaching, grasping and object manipulation movements. As they do this, the brain sends a signal to the muscle through the efferent pathway, once received the muscle sends a signal back to the brain through the afferent pathway allowing the patient to regain a voluntary movement. A variety of therapeutic exercises have been designed to provide patients with a range of reaching and grasping movements.
MyndMove therapy is the result of over a decade of clinical research at the Toronto Rehabilitation Institute (TRI), University Health Network (UHN). During that period, approximately 17 stroke patients were treated with the MyndMove therapy, which, in scientific publications, is called functional electrical stimulation (FES) therapy. All these treatments were well tolerated by patients.
Based on promising outcomes reported in randomized controlled studies, MyndTec Inc. has undertaken the development of MyndMove, a commercial version of the medical technology. The MyndMove device is designed to meet both medical device regulations and to facilitate the safe and effective delivery of therapy by providing an electronic user interface to guide the therapist during treatment delivery. The MyndMove device includes an 8 channel stimulator, a touchscreen interface, stimulation electrodes and cables, a backend data management system, and pre-programmed movement protocols.
MyndMove has been approved for use by Health Canada.
There are approximatively 50,000 strokes in Canada annually. There are about 300,000 people living with effects of a stroke.
There are 86,000 people in Canada living with spinal cord injury. Over 40% of patients need personal assistance with activities of daily living.
Who will benefit from MyndMove Therapy? (Click to expand)
MyndMove is a revolutionary non-invasive therapy that aims to restore voluntary movement to patients with upper-limb paralysis following stroke or spinal cord injury. Individuals who have suffered paralysis or hemiparesis to the arm and hand as a result of stroke or spinal cord injury are candidates for MyndMove therapy. The overall benefit realized by an individual will vary depending on a number of factors including severity of the paralysis, number of treatments, frequency of treatments and length of time after the stroke before treatment is initiated.
In order for patients to benefit from MyndMove, they must be medically stable, able to actively participate in and to communicate with the therapist during treatment. Physicians and clinicians will determine if MyndMove is appropriate for individual patients.
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MyndMove Therapy is delivered by specially trained and certified Physiotherapists and Occupational Therapists at accredited rehabilitation centers.
Over the course of the therapy, patients advance through a treatment regimen tailored to their recovery needs by their therapists.
MyndMove Therapy allows the therapist’s discretion in selection of movement Protocols for any particular session. This enables the therapists to reinforce recovered movements from previous sessions, introduce new movements or combinations from a selection of forward and side reach motions for the shoulder, to fine hand grasping and pinching control of fingers.
MyndMove can be integrated with other therapies and as part of a comprehensive neurorehabilitation program.
Therapist Training and Certification
Occupational Therapists and Physiotherapists undergo a comprehensive course in the fundamental principles of MyndMove FES, device operation, protocol selection, and hands-on practice resulting in the therapist being certified for the therapeutic delivery of the MyndMove.
Clinical Study (Click to expand)
Novo Healthnet is participating in a clinical study which is designed to address the clinical feasibility and usability of MyndMove Therapy in sub-acute and chronic severe Hemiparesis of the Upper Limb following stroke.
Many stroke patients suffer weakness or paralysis of their arms and hands. They are often unable to grasp and reach objects voluntarily and have difficulty performing basic activities of daily life such as dressing, feeding, bathing and grooming. Despite extensive rehabilitation programs, many of these individuals remain dependent on others for assistance with activities of daily living. This unmet medical need remains the focus of a wide range of research efforts.
MyndMove is a non-invasive medical device that uses short, low energy electrical pulses to induce muscle contractions. A variety of therapeutic stimulation sequences (TSS) or protocols have been designed to provide diverse reaching and grasping movements. Each TSS is designed to allow occupational therapists and physiotherapists to enable specific coordinated and articulated movements in the paralyzed arm and fingers in stroke patients. MyndMove enables a therapist to generate a full range of reaching and grasping movements, which the patient is unable to perform by him/herself. By using the MyndMove therapy to help the patient move his/her arm(s) and hand(s) as he/she attempts to carry out typical reaching, grasping and object manipulation movements, the patient gradually improves their ability to perform these tasks voluntarily.
How many people will take part in the study? (Click to expand)
45-75 people will take part in this study with five (5) patients per clinical site.
What benefits can I expect from being in the study? (Click to expand)
You may not directly experience any benefits from being part of the study. Ongoing studies such as this one provide information about the viability and effectiveness of emerging stroke and SCI rehabilitation therapy. The information collected from your participation has the potential to help future patients recover after stroke or SCI.
What side effects or risks can I expect from being in the study? (Click to expand)
Electrical stimulation therapy has some risks. Some of these risks are known based on experience with approved and marketed surface electrical stimulators such as neuromuscular electrical stimulators, functional electrical stimulators and transcutaneous electrical neuromuscular stimulators. Surface electrical stimulators should not be used:
- On people fitted with a pacemaker, an implantable defibrillator, or an implanted neurostimulation device
- On people suffering from epilepsy
- Near an unhealed bone fracture
- Over swollen, infected, or inflamed areas or skin eruptions, such as phlebitis, thrombophlebitis, and varicose veins
- On areas of the body if cancerous lesions are present or suspected
- On or around the abdomen of pregnant women
If any of the above issues or concerns are true for you, please inform the research study staff immediately.
What are the costs of taking part in this study? (Click to expand)
You will receive this treatment at no cost to you. You will not be paid to participate in this study. You will not be reimbursed for your expenses related to your participation in the study.
Participating Clinics And Clinical Study (Click to expand)
If you are interested in being considered for participation in the MyndMove Therapy Clinical Study(if you meet inclusion criteria) (September 1 – January 31, 2015), please download the referral form below and fax or email to the locations listed below.
Visit MyndTec for more information