Tokyo, July 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062298) titled 'The effectiveness of a group intervention for those who have stopped driving after brain injury' on July 22.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - Nagoya City Rehabilitation Agency
Condition:
Condition - Brain injury
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Testing the effectiveness of group intervention for those who have stopped driving after brain injury.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - The intervention group will receive the group intervention focusing on driving discontinuation and local transportation in Phase 1. In Phase 2, neither assessments nor interventions will be conducted.
Interventions/Control_2 - The contorol group will receive standard information using a guidebook in Phase 1. They will receive the group intervention focusing on driving discontinuation and local transportation in Phase 2.
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - Persons diagnosed with brain injury
Those who have stopped driving after brain injury
Persons whose consent was obtained after receiving an explanation.
Key exclusion criteria - Persons whose driving with no restrictions
Target Size - 40
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2026 Year 06 Month 10 Day
Date of IRB - 2026 Year 06 Month 22 Day
Anticipated trial start date - 2026 Year 07 Month 22 Day
Last follow-up date - 2028 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071293
Disclaimer: Curated by HT Syndication.
