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Evaluation of the efficacy and safety of SHINI hand-training device, with device optimization, in chronic stroke

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Stroke
Date of first enrollment	09/02/2026
Target sample size	15
Countries of recruitment
Study type	Interventional
Intervention(s)	Content: 20 minutes of training with SHINI-2 (investigational device) and 20 minutes of upper-limb functional training Dose per session: 40 minutes Frequency: 1-4 sessions per week Treatment period: 3-4 weeks Total sessions: 8-12 sessions within the 3-4-week period

Outcome(s)

Primary Outcome

Occurence of Clinical Trial Act-defined disease, etc. events, summarized as (i) the number of events, and (ii) the number and proportion of participants with one or more event

Secondary Outcome

Device optimization Device deficiency Blood pressure Heart rate Oxygen saturation Fugl-Meyer Assessment for the Upper Extremity Modified Ashworth Scale Hand circumference at the metacarpophalangeal joint level. Range of motion of the upper limb and fingers Tip-to-palm distance Action Research Arm Test Box and Block Test Motor Activity Log Grip strength Pinch strength Surface electromyography of flexor digitorum superficialis, extensor digitorum communis, flexor carpi radialis, flexor carpi ulnaris, abductor pollicis longus, abductor digiti minimi, etc Functional Independence Measure EQ-5D-5L General Self-Efficacy Scale modified Borg Scale Questionnaire

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	Patients with chronic stroke (6 months or more post-onset) who have hand function impairment. Age 18 years or older. Able to provide written informed consent after adequate explanation of the study objectives and methods
Exclude criteria	Severe cognitive impairment or severe communication disorder that makes it difficult to understand instructions or carry them out. Unstable vital signs. PR. (Heart rate greater than 120 beats per minute. Symptomatic bradycardia, for example a heart rate less than 50 beats per minute. Systolic blood pressure 180 millimetres of mercury or higher, or less than90 millimetres of mercury. Diastolic blood pressure110 millimetres of mercury or higher Oxygen saturation (SpO2) below 92 percent.) Physical conditions unsuitable for the use of SHINI, such as marked spasticity or joint contractures that make passive joint movement difficult. Deemed inappropriate for participation by the principal investigator