Clinical research for efficacy and safety of hand-finger rehabilitation robot SMOVE for the patients with upper limb paresis after recovery stage stroke patients

Clinical research for efficacy and safety of hand-finger rehabilitation robot SMOVE in the goods operation training for the patients with upper limb paresis after recovery stage stroke patients: A pilot study under single center, open-label, randomized, standard therapy controlled trial. - SMOVE pilot study_02

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs072180005

Enrollment

Registered

2018-10-25

Start date

2018-12-28

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

Subacute stage cerebral stroke patients with upper limb paresis Cerebrovascular Stroke

Interventions

3 week intervention (7days a week). Subjects in SMOVE group receive a 20 min. normal training session for upper extremity following another 20 min. training session for upper extremity with SMOVE on.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age Between 20 y.o. and 85 y.o. Patients in convalescent stage (15 days to 42 days after onset) with cerebral stroke (cerebral infarction or hemorrhage) being treated with rehabilitation therapy in convalescent stage rehabilitation beds. with hand/finger Brunnstrom stage III to IV

Exclusion criteria

Exclusion criteria: Patients with subarachnoid hemorrhage having upper limb paresis caused not by cerebral stroke. with severe hepatic / renal /cardiac / pulmonary failure with malignant tumor not completely cured whose skin condition is not suitable for electrodes placement, or device putting on their hands. with severe spasticity ( upper than MAS 3) who are treated with type A botulinus toxin or ITB therapy

Design outcomes

Primary

Measure	Time frame
Change value of Fugl-Meyer-Assessment Upper Extremity (FMA-UE) on Day22 after starting examination	—

Secondary

Measure	Time frame
Secondary endpoints 1) Brunnstrom stage (Upper limbs) 2) Brunnstrom stage (hands) 3) Box and Block test 4) Action Research Arm Test 5) Simple Test for Evaluating hand Function 6) Modified Ashworth Scale 7) Grip 8) Pinch 9) Functional Independent Measure Safety endpoints 1) The incidence rates during the study intervention period of adverse events 2) The incidence rates during the study intervention period of device defects	—

Measure

Time frame

Secondary endpoints 1) Brunnstrom stage (Upper limbs) 2) Brunnstrom stage (hands) 3) Box and Block test 4) Action Research Arm Test 5) Simple Test for Evaluating hand Function 6) Modified Ashworth Scale 7) Grip 8) Pinch 9) Functional Independent Measure Safety endpoints 1) The incidence rates during the study intervention period of adverse events 2) The incidence rates during the study intervention period of device defects

—

Contacts

Public ContactNobutaka Mukae

Kyushu University Hospital

mukae@ns.med.kyushu-u.ac.jp+81-92-642-5524

Outcome results

None listed

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