Tokyo, April 7 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061166) titled 'A Fundamental Study of Brain Representation Mechanisms Using fNIRS: Insights into Verticality Perception and Balance Control' on April 7.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - SBC Tokyo Medical University
Condition:
Condition - Healthy participants, Stroke
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The objective is to elucidate the neural substrates underlying balance assessment and to clarify clinical applications by identifying the underlying mechanisms of balance training.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Interventions consist of truncal tilt training performed under two conditions. The specific intervention involving a wedge involves inserting a wedge under the ischial tuberosity on the hemiparetic side during maximum lateral truncal tilt training.
Interventions/Control_2 - The control group performs maximum lateral truncal tilt training without a wedge.
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male and Female
Key inclusion criteria - Patients with first-ever stroke resulting in hemiplegia
Presence of supratentorial lesions
Individuals who provided informed consent after receiving a verbal explanation
Key exclusion criteria - Withdrawal of consent or a request to decline participation by the subject.
Cases where the principal investigator or sub-investigator determines that discontinuation is appropriate for other reasons.
Target Size - 52
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 04 Month 07 Day
Date of IRB - 2025 Year 09 Month 04 Day
Anticipated trial start date - 2026 Year 04 Month 07 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=R000069997
Disclaimer: Curated by HT Syndication.