Tokyo, Aug. 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058828) titled 'Effect of NP-FES (Electrical Stimulation) on Hand Blood Flow in Elderly Stroke Patients Differences Between Severe and Mild Paralysis' on Aug. 21.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - Gunma Paz University

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

Objective: Narrative objectives1 - The objective of this study is to clarify the effects of Neuroprosthetic Functional Electrical Stimulation (NP-FES) on peripheral circulation in patients with chronic stroke. In particular, the study aims to compare blood flow responses between the severe paralysis group (Brunnstrom Recovery Stage 2 or below) and the mild paralysis group (Brunnstrom Recovery Stage 5 or above), and to identify the onset timing and differences in responsiveness of circulatory improvement. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Electrical stimulation (70 Hz, 120 ms) is applied to the paretic extensor muscles, triggered by electromyographic signals from the non-paretic side, to induce joint movement.

Stimulation is delivered for 4 minutes per session.

Frequency: twice a week for 4 weeks (8 sessions in total).

Measurement timing: before stimulation, immediately after stimulation, and 3 minutes post-stimulation.

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients with chronic stroke, at least 1 year after onset

Hemiplegia with Brunnstrom Recovery Stage of 2 or below, or 5 or above

Age 20 years or older

Written informed consent obtained from the participant Key exclusion criteria - Patients with cognitive impairment that makes it difficult to understand the study or provide informed consent

Patients with severe cardiac, respiratory, or orthopedic conditions that preclude safe intervention

Patients with skin disease, infection, or injury at the electrode placement site

Patients with implanted electronic devices such as pacemakers Target Size - 20

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2022 Year 11 Month 01 Day Date of IRB - 2021 Year 07 Month 28 Day Anticipated trial start date - 2023 Year 01 Month 05 Day Last follow-up date - 2024 Year 11 Month 10 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067268

Disclaimer: Curated by HT Syndication.