Hemiparesis of the Upper Limb Following Stroke Clinical Trial
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.
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
;