Tokyo, July 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062166) titled 'A Study of Seated Balance Training Using a Virtual Reality Device in Patients with Acute Stroke' on July 9.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Southern Tohoku General Hospital, Southern Tohoku Research Institute for Neuroscience

Condition: Condition - cerebral infarction, cerebral hemorrhage Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the feasibility of adding seated VR training to conventional physical therapy in patients with acute stroke, and to preliminarily estimate effect sizes to inform a subsequent confirmatory RCT. Basic objectives2 - Others

Intervention: Interventions/Control_1 - Intervention group: In addition to conventional physical therapy (40 min/day), patients receive seated VR training using mediVR Kagura (20 min/day), for a total of 60 min/day. The VR task is a seated reaching task (horizontal game) in which patients reach for targets presented in the VR space using a hand-held controller. The size, distance, and range of the targets are adjusted according to each patient's physical function. If patients have difficulty holding the controller with the paretic upper limb, the controller is fixed to the shoulder with a band. The VR training is performed 10 sessions in total over 14 days, starting from day 5 or later after stroke onset. Conventional physical therapy includes range-of-motion exercises, muscle strengthening, gait training, and ADL training. Occupational therapy and speech therapy are provided to both groups with equivalent frequency and duration as needed. Interventions/Control_2 - Control group: Patients receive conventional physical therapy for 60 min/day for 14 days, including range-of-motion exercises, muscle strengthening, sitting and standing balance training, sit-to-stand training, gait training, and ADL training, with qualitative content equivalent to the conventional physical therapy provided to the intervention group. Occupational therapy and speech therapy are provided to both groups with equivalent frequency and duration as needed.

Eligibility: Age-lower limit - 18 years-old

Gender - Male and Female Key inclusion criteria - 1. Patients with first-ever supratentorial cerebral infarction or intracerebral hemorrhage (excluding subarachnoid hemorrhage) 2. Within 5 to 10 days after stroke onset 3. Aged 18 years or older and younger than 85 years 4. Functional Ambulation Categories (FAC) 0-2 (unable to walk to walking with assistance) 5. Able to maintain a sitting position on the edge of the bed for at least 1 minute 6. Mini Mental State Examination (MMSE) score of 20 or higher 7. Japan Coma Scale (JCS) of single-digit or better, with the ability to understand the assessments and VR tasks 8. Patients who received an explanation of the study and provided written informed consent Key exclusion criteria - 1. Patients with severe visual or hearing impairment that makes it difficult to perform the VR tasks 2. Patients with a history of adverse events such as VR sickness (cybersickness) 3. Patients for whom exercise therapy is contraindicated due to active infection, fracture, severe pain, hemodynamic instability, or other conditions 4. Patients judged inappropriate for participation by the attending physician or study investigators from the perspective of safety or study validity Target Size - 30

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 06 Month 28 Day Date of IRB - 2026 Year 07 Month 06 Day Anticipated trial start date - 2026 Year 07 Month 13 Day Last follow-up date - 2027 Year 11 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071142

Disclaimer: Curated by HT Syndication.