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

JRCT ID: jRCTs072180005

Registered date:25/10/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Subacute stage cerebral stroke patients with upper limb paresis
• Date of first enrollment: 28/12/2018
• Target sample size: 16
• Study type: Interventional

Intervention(s)

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. Subjects in non-SMOVE group receive a 20 min. normal training session for upper extremity following another 20 min. training session for upper extremity without SMOVE.

Outcome(s)

• Primary Outcome: Change value of Fugl-Meyer-Assessment Upper Extremity (FMA-UE) on Day22 after starting examination

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 85age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Kagiyama Tomoko