Tokyo, April 27 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061380) titled 'A study investigating whether training to improve visual attention can help improve to activities of daily living in patients with subacute stroke' on April 26.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -but assessor(s) are blinded
Control - Active
Primary Sponsor:
Institute - Tokyo Bay Rehabilitation Hospital
Condition:
Condition - Stroke
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To clarify the effect of visual attention training on improving ADL abilities compared to auditory attention training in patients with subacute stroke.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Visual attention function training. In addition to standard rehabilitation interventions, interventions lasting approximately 20 minutes each will be conducted 5 days a week for 3 weeks outside of clinical time. The rehabilitation tool (touch panel mode) from Attention (Creact Co., Ltd.) was used. The sequence of passive element order to random, active element deletion to coloring to deletion noise to coloring noise was repeated twice. Evaluations will be conducted before and after the intervention and at discharge.
Interventions/Control_2 - Auditory attention function training.
In addition to standard rehabilitation interventions, interventions lasting approximately 20 minutes each will be conducted 5 days a week for 3 weeks outside of clinical time. The Paced Auditory Serial Addition Test (PASAT), included in the Clinical Assessment for Attention - Revised (CAT-R), was used.
The process of practicing under the 2-second condition followed by the actual trial, and then practicing under the 1-second condition followed by the actual trial, will be repeated twice in sequence. Evaluations will be conducted before and after the intervention, and at discharge.
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - Inclusion criteria were as follows: patients with a first-ever stroke (cerebral infarction or cerebral hemorrhage); those who were more than 3 months post-stroke; individuals who were independent in activities of daily living prior to stroke onset; and those for whom consent was obtained from the attending physician.
Key exclusion criteria - Exclusion criteria were as follows: patients with subarachnoid hemorrhage; those aged less than 20 or greater than or equal to 90 years; those with scattered cerebral infarctions; those with infratentorial lesions; patients with clear visual or hearing impairments at the time of recruitment; those with evident aphasia at recruitment; those who scored less than 24 on the MMSE-J at the most recent evaluation at recruitment; those who scored less than 3 on the SIAS visuospatial perception item at the most recent evaluation at recruitment; those with a motor FIM score greater than or equal to 78 or less than 39 at recruitment; those who required greater than or equal to 300 seconds to complete the TMT-J Part A during the pre-evaluation; those hospitalized for clinical trials or for post-stroke sequelae; those participating in other intervention studies; those who wished to resume driving after stroke and were undergoing evaluation; and those who did not provide consent.
Target Size - 28
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 03 Month 06 Day
Date of IRB - 2026 Year 03 Month 06 Day
Anticipated trial start date - 2026 Year 04 Month 26 Day
Last follow-up date - 2029 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070231
Disclaimer: Curated by HT Syndication.