OASIS STUDY Outcome Assessment Using SF-36 v2 in Stroke Patient Study(OASIS STUDY)

Completed

• Conditions: Stroke

• Registration Number: NCT00281034
• Lead Sponsor: Kyorin Pharmaceutical Co.,Ltd

Brief Summary

1. To survey the health-related quality of life using the SF-36v2 score of patients with chronic brain infarction in Japan

2. Chronic brain infarction in Japan is better than EU/USA

Detailed Description

Period:2005-2007

Observation Time:baseline, 8week, 24week

matters investigated:

1. QOL determination using SF-36 v2

2. Age, sex, brain infarction type, stroke severity (modified Rankin scale), side of stroke, complication, smoking, alcohol, dizziness-vertigo-presyncope-light headedness, combination medicine, subjective symptoms, psychic symptoms, rehabilitation, recurrence, evaluation of depression (Japan-Stroke Scale (JSS)-D)

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2006-01-23
• Study First Submitted QC: 2006-01-23
• Study First Posted: 2006-01-24
• Study Completion: 2007-07
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-10
• Last Update Posted: 2012-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2069

Inclusion Criteria

1. Patients whose last attack occurred more than 1 month ago
2. Outpatients (including hospitalization for rehabilitation)
3. Japanese nationality
4. Patients who consented to participate in this study
5. Group I: Patients with dizziness, vertigo, presyncope, and light-headedness which are likely due to secondary chronic cerebral circulation impairment associated with sequelae of brain infarction, and patients for whom KETAS (IBUDILAST) was prescribed Group II: Patients without dizziness, vertigo, presyncope, and light-headedness which are likely due to chronic cerebral circulation impairment associated with sequelae of brain infarction

Exclusion Criteria

1. Patients who cannot read, understand and fill in the questionnaire by themselves
2. Patients who idle their time away
3. Patients who are hospitalized
4. Patients who are undergoing treatment for dizziness, vertigo, presyncope, light-headedness which are likely due to chronic cerebral circulation impairment associated with sequelae of brain infarction
5. Patients whose dizziness, vertigo, presyncope, and light-headedness is definitely or likely caused by Meniere disease, vestibular neuronitis, benign paroxysmal positional vertigo, otitis media, or epilepsy6. Patients whom the investigator judges are not suitable to participate in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
score of SF-36	0, 8 week, 24 week

Trial Locations

Locations (1)

Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital; 🇯🇵 Tachikawa-City, Tokyo, Japan