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

Phase 2

• Conditions: Subacute stage cerebral stroke patients with upper limb paresis; Cerebrovascular Stroke; D020521

• Registration Number: JPRN-jRCTs072180005
• Lead Sponsor: Kagiyama Tomoko

Brief Summary

o significant difference in recovery of affected hand / upper limb function due to the difference in intervention between the two groups was revealed. No serious side effects due to SMOVE or malfunction of SMOVE during the intervention were observed.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-25
• Study Completion: 2020-04-28
• Results First Posted: 2022-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 16

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change value of Fugl-Meyer-Assessment Upper Extremity (FMA-UE) on Day22 after starting examination

Secondary Outcome Measures

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