Tokyo, July 3 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062115) titled 'Effects of weight-bearing training using a Perceptual Stimulus Insole (PSI) on standing balance in patients with post-stroke hemiplegia' on July 2.

Study Type: Interventional

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

Primary Sponsor: Institute - NHO Shikoku Medical Center for Children and Adults

Condition: Condition - Acute post-stroke hemiplegia Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to examine, in patients with acute post-stroke hemiplegia, the effects and characteristics of postural-control motor tasks including weight-bearing training with a Perceptual Stimulus Insole (PSI) on paretic-side weight-bearing ratio and center-of-pressure sway. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - In addition to standard physical therapy, participants wear a Perceptual Stimulus Insole (PSI) and perform weight-bearing training toward the paretic and non-paretic sides, with weight position taught through plantar sensory input. The weight-bearing training consists of 4 sets over 10 minutes. All assessments are performed without the PSI, before and immediately after the intervention. Interventions/Control_2 - In addition to standard physical therapy, participants perform weight-bearing training toward the paretic and non-paretic sides with verbal instruction of weight position. The weight-bearing training consists of 4 sets over 10 minutes (identical intervention time and standard physical therapy as the intervention group).

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - Patients with acute post-stroke hemiplegia presenting unilateral motor paresis due to cerebrovascular disease; able to understand task instructions; able to stand up and maintain standing independently; and willing to participate in the study. Key exclusion criteria - Patients with impaired consciousness; severe aphasia, apraxia, or agnosia; or orthopedic disorders affecting postural control. Target Size - 40

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 01 Month 15 Day Date of IRB - 2026 Year 01 Month 26 Day Anticipated trial start date - 2026 Year 08 Month 10 Day Last follow-up date - 2027 Year 08 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071079

Disclaimer: Curated by HT Syndication.