Tokyo, Aug. 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058477) titled 'Evaluation of the Effectiveness of Non-Pharmacological Interventions for Improving Apathy after Stroke' on Aug. 1.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -but assessor(s) are blinded
Control - Active
Primary Sponsor:
Institute - Kawasaki University of Medical Welfare
Condition:
Condition - Post-stroke apathy
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study aims to compare the effectiveness of three non-pharmacological interventions: cognitive training, physical exercise, and behavioral therapy for improving post-stroke apathy and to identify the most beneficial approach.
Basic objectives2 - Others
Intervention:
Interventions/Control_1 - Cognitive training will be provided for 40 minutes per day, 5 days per week, for 2 weeks (total 10 sessions). Training includes visual scanning tasks, verbal fluency tasks, and constructional tasks. The intervention will be administered by clinical rehabilitation staff.
Interventions/Control_2 - Physical exercise will be conducted for 40 minutes per day, 5 days per week, for 2 weeks (total 10 sessions). The intervention includes sit-to-stand training, gait training, and muscle strengthening exercises. The intervention will be administered by clinical rehabilitation staff.
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male and Female
Key inclusion criteria - Ability to provide written informed consent, Aged between 18 and 79 years, Right-handed, MMSE score of 23 or higher, AES score of 37 or higher, Diagnosed with post-stroke apathy within 3 months after stroke onset
Key exclusion criteria - Patients with severe systemic diseases that hinder participation in rehabilitation, or with psychosis, depression, disturbance of consciousness, or hearing or visual impairments that interfere with assessment.
Target Size - 42
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 08 Month 01 Day
Anticipated trial start date - 2025 Year 08 Month 01 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=R000066640
Disclaimer: Curated by HT Syndication.