Acute stroke acute stroke ,
Conditions
Interventions
A single-center, randomized-controlled study.
Rehabilitation glasses (REHA glasses) enable the tilt of the visual field according to the body tilt in patients with lateropulsion. REHA glasses make the
single center, double-blind, randomized-controlled study, rehabilitation glasses
Sponsors
Yokota Chiaki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) aged 20 - 89 years old 2) admission to the Stroke Care Unit within 48 hours of stroke onset (hemispheric stroke) 3) first-ever stroke 4) moderate to severe lateropulsion, defined as a score of spontaneous body posture > 1.0 on the Scale for Contraversive Pushing on the day of informed consent (within 14 days after the onset of stroke) 5) right-handed 6) ability to start intervention of the study between 7 and 14 days after the onset of stroke 7) getting written informed consent (allowed signature by proxy)
Exclusion criteria
Exclusion criteria: 1)communication difficulties due to impaired consciousness, impaired cognitive function, and severe aphasia 2) a premorbid Functional Ambulation Category 0-2 3) patients with mental disorders or cognitive dysfunction who are unable to understand the study protocol 4) pregnant women 5) patient with an implantable electrical cardiac device 6) patients who are unable to undergo rehabilitation safely after putting on the rehabilitation glasses 7) patients who are unsuitable to participate in the study by the other problems
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of participants with an improvement of one point or above in the Functional Ambulation Categories (FAC) from baseline to post-intervention (after completing five sessions of the intervention). | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy outcomes 1) Proportion of participants with a Functional Ambulation Categories (FAC) score of 3-5, and proportion of participants capable of independent 50 m walking (at post-intervention) 2) Changes in the Scale for Contraversive Pushing, Fugl-Meyer Assessment (subscores of lower extremity and balance), Functional Independence Measure, Subjective Visual Vertical, Apathy Score, and Mini-Mental State Examination (from baseline to post-intervention) 3) Proportion of participants with FAC score of 3-5, and proportion of participants capable of independent 50 m walking (at 90 days after stroke onset) Safety outcomes 1) Occurrence of cybersickness symptoms (e.g., nausea, dizziness, and discomfort) possibly related to the use of REHA-glasses 2) Occurrence of falls during the use of REHA-glasses 3) Worsening of neurological symptoms during the use of REHA-glasses (NIHSS score 2 or above) 4) Occurrence of recurrent stroke or cardiovascular diseases (e.g., ischemic heart disease, heart failure, or major vascular diseases such as aortic dissection) during the use of REHA-glasses | — |
Contacts
Public ContactChiaki Yokota
National Cerebral and Cardiovascular Center
Outcome results
None listed