Casa Colina Hospital and Centers for Healthcare
The goal of this clinical trial is to learn about the safety, tolerability, and feasibility of ExaStim transcutaneous electrical stimulation combined with task-specific rehabilitation, and to characterize changes in arm function in adults with chronic unilateral ischemic stroke. The main questions it aims to answer are: * Does 12 weeks of ExaStim stimulation combined with structured, task-specific rehabilitation improve arm function? * What are the safety, tolerability, and feasibility of ExaStim use in individuals with chronic stroke? Participants will: * Complete a 12-week intervention period combining ExaStim transcutaneous electrical stimulation with structured, task-specific rehabilitation * Undergo clinical assessments and outcome testing baseline, week 4, week 8, week 12, and week 17 (follow-up) * Monitor and report pain and quality of life via Visual Analog Scales (VAS) and questionnaires throughout the 17-week study duration
Primary exploratory clinical objective: To characterize change in upper extremity motor impairment following 12 weeks of ExaStim stimulation combined with structured, task-specific rehabilitation in individuals with chronic stroke. Secondary objective: To characterize safety, tolerability, and feasibility of ExaStim use in individuals with chronic stroke. Exploratory objectives include describing immediate on/off-stimulation differences in dexterity and persistence of observed changes at Week 17; the design is not intended to establish causal effectiveness. Additional exploratory outcomes:…
Inclusion Criteria: 1. Subject must have a documented diagnosis of a singular unilateral ischemic stroke event confirmed by radiology report. 2. Participant is in the chronic stage of neurological recovery, defined as at least 6 months after the unilateral ischemic stroke event. 3. Subject is aged 18-75 years 4. In the investigators or qualified clinician's judgment, the subject must possess sufficient global cognitive capacity to understand and follow study-related instructions, actively participate in task-specific rehabilitation, and provide informed consent. Cognitive capacity will be sup…
Week 0 includes one baseline assessment session and two to three parameter optimization sessions. Participants will attend 2 rehabilitation sessions per week for 12 weeks, for a total of 24 sessions. Each session will provide \~60 minutes of rehabilitation, including at least 45 minutes of active stimulation delivered concurrently with therapeutic activity. The therapist will select activities according to participant goals, affected-arm capacity, movement quality, fatigue, pain, and cardiovascular tolerance. Each session will emphasize repeated practice, functional strength or functional practice. Missed sessions will be rescheduled within the 12-week period if appropriate. Separate assessment visits occur in Weeks 4, 8, 12, and 17 and may last approximately one to two hours with rest breaks. The final evaluation is scheduled for Week 17. All assessments will use the same participant-specific baseline date as the time reference, and actual visit dates and intervals will be recorded.
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