Tokyo, June 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061872) titled 'An Evaluation of the Initial Efficacy of a One-Handed Game Controller: A Randomized Crossover Trial' on June 15.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - Sonoda-kai Neuro-Rehabilitation Hospital

Condition: Condition - Cerebrovascular disease Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The aim is to conduct an exploratory evaluation of the device's feasibility and initial efficacy Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Conduct an evaluation of a custom-made game using the one-handed game controller developed in this study Interventions/Control_2 - Conducting a self-designed game evaluation task using an existing one-handed game grip

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - 1) Patients who have experienced a first stroke and exhibit symptoms on only one side (regardless of symptom severity) 2) Patients capable of operating this device or an existing single-hand game controller with either their left or right upper limb 3) Patients who can maintain a seated position independently, or who can safely maintain a seated position in their usual chair or wheelchair Key exclusion criteria - 1)Individuals with impaired cognitive function (MMSE score of 23 or lower) 2)Individuals who have difficulty understanding or performing game tasks or answering questionnaires due to higher-level cognitive impairments such as severe visual or hearing impairments, aphasia, or attention disorders 3)Individuals deemed unable to participate safely due to pain, fatigue, dizziness, blood pressure fluctuations, or poor general health 4)Individuals for whom game operation is deemed inappropriate due to upper limb immobilization or weight-bearing restrictions, postoperative contraindications, or activity restrictions prescribed by a physician 5)Individuals from whom informed consent for the study cannot be obtained Target Size - 24

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 06 Month 06 Day Date of IRB - 2026 Year 06 Month 06 Day Anticipated trial start date - 2026 Year 06 Month 10 Day Last follow-up date - 2027 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070796

Disclaimer: Curated by HT Syndication.