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

JRCT ID: jRCT2062190037

Registered date:04/03/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Stroke
• Date of first enrollment: 10/11/2020
• Target sample size: 70
• Study type: Interventional

Intervention(s)

Intervention: neurofeedback training
Control: standard rehabilitation

Outcome(s)

Primary Outcome

Proportion of patients achieving both 1 and 2 below;
1. Improvement of 3 points or more on the Berg Balance Scale from baseline to 8 weeks after the start of intervention
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

1) 3m-Timed Up and Go Test
- Change over time from baseline
- Improvement rate from baseline to 8 or 12 weeks after start of intervention
2) Berg Balance Scale
- Change over time from baseline
- Change from baseline to 8 or 12 weeks after start of intervention
- Proportion of patients who improved 3 or more points from baseline to 8 or 12 weeks after start of intervention
3) Functional Ambulation Category
- Proportion of patients who improved by 1 or more from baseline to 8 or 12 weeks after start of intervention
4) Modified Ashworth Scale
- Change from baseline to 8 or 12 weeks after start of intervention
5) 10 m walk test
- Change over time from baseline
- Proportion of patients who improved 0.1 m/s or more from baseline to 8 or 12 weeks after the start of intervention
6) Fugl-Meyer Scale
- Change over time from baseline
7) Functional Independence Measure
- Change over time from baseline
8) Average number of steps and activity by activity meter
- Change over time from baseline
9) Clinical Global Impressions - global improvement with respect to gait function
- Score at 8 or 12 weeks after the start of the intervention
10) Number of fall
- Number of fall from baseline to 8 or 12 weeks after start of intervention
11) Apathy scale
- Change from baseline to 8 or 12 weeks after start of intervention

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Mihara Masahito
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development,Shimadzu corporation