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

Exploratory study evaluating the efficacy and safety of the SHINI hand-training device in patients with chronic stroke, with iterative device optimization

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs032250521

Enrollment

Registered

2025-11-25

Start date

2026-02-09

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke Stroke, Cerebral infarction, Cerebral hemorrhage

Interventions

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:

D012046, D000071939, D000066530

rehabilitation, hand function training, stroke rehabilitation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Contacts

Public ContactGaku Watanabe

University of Tsukuba Hospital

watanabe.gaku.mv@ms.hosp.tsukuba.ac.jp+81-29-853-3795

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026