Investigator-initiated trial of NIRS neurorehabilitation system for poststroke gait disturbance.
- Conditions
- Stroke
- Registration Number
- JPRN-jRCT2062190037
- Lead Sponsor
- Mihara Masahito
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 70
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
11) Patients with skin lesions requiring treatment on the scalp
12) pregnant women
13) Patients with a score of 11 or higher on Geriatric depression scale 15
14) Patients with a history of or complicated with clinically significant neuropsychiatric disorders
15) Patients receiving botulinum toxin therapy, robot rehabilitation, BMI rehabilitation, transcranial magnetic stimulation, transcranial electrical stimulation, or transcutaneous functional electrical stimulation within 6 months prior to enrollment
16) Patients whose participation in this study is judged to be inappropriate by the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients achieving both 1 and 2 below;<br>1. Improvement of 3 points or more on the Berg Balance Scale from baseline to 8 weeks after the start of intervention<br>2. Improvement of 0.1 m/s or more in the 10m walk test from baseline to 8 weeks after the start of intervention
- Secondary Outcome Measures
Name Time Method