Investigator-initiated trial of NIRS neurorehabilitation system for poststroke gait disturbance. - NIRS-G01

Mihara Masahito0 sites70 target enrollmentMarch 4, 2020

ConditionsStroke

Overview

No summary available.

Registry

who.int

Start Date

March 4, 2020

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Mihara Masahito

•1\) Patients aged 20 years or older with written informed consent from the patient to participate in the study
•2\) Patients with gait disturbance due to first clinical episode of cerebral infarction or intraparenchymal hemorrhage
•3\) Patients aged 12 weeks or more but less than 32 weeks after onset at enrollment
•4\) Patients with a Functional Ambulation Category 3\-4 at enrollment
•5\) Patients with a Berg Balance Scale \<\= 50 at enrollment
•6\) Patients who can sit with feet soles on the floor for at least 10 minutes
•7\) Patients who can be stably evaluated by the Berg balance scale and 10 m walking under the use of assistive devices such as an orthosis and a cane
•8\) Patients who can understand verbal instructions and perform tasks adequately

•1\) Patients with severe cognitive impairment, a Mini\-mental State Examination \<\= 23
•2\) Patients with severe frontal lobe dysfunction, a Frontal Assessment Battery \<\= 12
•3\) Patients with severe leg anesthesia, score 1, the patient recognizes movement of the digits but not the correct direction, even at maximal excursion, or less of the position sense (lower extremity) subscale in Stroke Impairment Assessment Set
•4\) Patients with more than 90% stenosis in anterior cerebral artery on the lesion side
•5\) Patients with cortical lesions involving the supplementary motor area
•6\) Patients with a history of cranioplasty
•7\) Patients with homonymous hemianopsia or severe hemispatial neglect (More than 10% deviation in a 50 cm line bisection test)
•8\) Patients with unstable general condition including vital sign
•9\) Patients with severe eyesight deterioration (Binocular visual acuity of 0\.05 or less with correction)
•10\) Patients with severe infections