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.
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
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
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.
Unnamed facility
Brampton, Ontario, Canada
Unnamed facility
London, Ontario, Canada
Unnamed facility
Oshawa, Ontario, Canada
Unnamed facility
Ottawa, Ontario, Canada
Unnamed facility
Toronto, Ontario, Canada
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
Time frame: baseline to 6 weeks
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.
Time frame: Baseline - 6 weeks
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).
Time frame: An average of 5 weeks after therapy has begun
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Unnamed facility
Windsor, Ontario, Canada
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.
Time frame: Baseline - An average of 5 weeks after therapy has begun
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.
Time frame: Throughout study