JRCT ID: jRCTs072250123
Registered date:08/01/2026
Effects of noisy galvanic vestibular stimulation patients with stroke
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | Stroke |
| Date of first enrollment | 02/02/2026 |
| Target sample size | 40 |
| Countries of recruitment | |
| Study type | Interventional |
| Intervention(s) | noisy galvanic vestibular stimulation |
Outcome(s)
| Primary Outcome | change in COP (Center Of Pressure) sway area at baseline and stimulation in mCTSIB (modified Clinical Test of Sensory Interaction in Balance). |
|---|---|
| Secondary Outcome | 1) Change in COP total trajectory length at baseline and stimulation in mCTSIB. 2) Changes in body sway indicators at baseline and stimulation in static standing using force plate and head IMU (Inertial Measurement Unit). 3) Changes in ankle strategy responses at baseline and stimulation in standing on a vibrating platform. 4) Change in maximum walking speed at baseline and stimulation in the 10-meter walking test. 5) Changes in body sway indicators at baseline and stimulation in IMU attached during 10-meter walking test. |
Key inclusion & exclusion criteria
| Age minimum | > 18age old |
|---|---|
| Age maximum | Not applicable |
| Gender | Both |
| Include criteria | 1. Individuals who have voluntarily provided written informed consent. 2. Individuals who are 18 years or older at the time of consent, regardless of sex. 3. Individuals who have been diagnosed with intracerebral hemorrhage or cerebral infarction within the past 3 months and currently admitted to a convalescent rehabilitation ward of the medical institution. 4. Individuals with a Functional Ambulation Categories score of 3 or higher after stroke. |
| Exclude criteria | 1. Individuals who may affect balance and walking with a history of orthopedic disorders, peripheral vestibular disorders, central nervous system diseases or psychiatric disorders. 2. Individuals with a Functional Ambulation Categories score of 3 or lower prior to the onset of stroke. 3. Individuals who are unable to understand the purpose of the study due to severe cognitive impairment or higher brain dysfunction. 4. Individuals with implanted metallic devices such as pacemakers, deep brain stimulation devices, or cochlear implants. 5. Individuals with intracranial implanted metallic devices such as clips and coils, ventriculo-peritonel shunt, the endoprosthesis. 6. Individuals with skin injuries such as lacerations at the electrode application site. 7. Pregnant or breastfeeding individuals. 8. Individuals deemed unsuitable for study participation by the principal investigator, sub-investigators, or research collaborators. |
Related Information
| Primary Sponsor | Mitsutake Tsubasa |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Tsubasa Mitsutake |
| Address | 5-1-1 Nabeshima, Saga city, Saga Japan Saga Japan 849-8501 |
| Telephone | +81-952-34-2180 |
| mitsuba@cc.saga-u.ac.jp | |
| Affiliation | Saga University |
| Scientific contact | |
| Name | Tsubasa Mitsutake |
| Address | 5-1-1 Nabeshima, Saga city, Saga Japan Saga Japan 849-8501 |
| Telephone | +81-952-34-2180 |
| mitsuba@cc.saga-u.ac.jp | |
| Affiliation | Saga University |