Clinical Trial: Effects of Unilateral Vibration Stimulation on Muscle Tone in Contralateral Homologous Muscles in Patients with Post-Stroke Spasticity (Japan)

Tokyo, Aug. 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058736) titled 'Effects of Unilateral Vibration Stimulation on Muscle Tone in Contralateral Homologous Muscles in Patients with Post-Stroke Spasticity' on Aug. 8.

Study Type: Interventional

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

Primary Sponsor: Institute - Graduate School of Kansai University of Health Sciences

Condition: Condition - Stroke patients Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to investigate whether unilateral vibration stimulation suppresses spasticity during stimulation in patients with post-stroke spasticity. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Vibration stimulation generally requires setting the frequency, amplitude, load weight, stimulation site, and stimulation time. In this study, a vibration stimulus with a frequency of 80 Hz, amplitude 0.4 mm, and load weight 400 g for 70 seconds to the FCR on the paralyzed side. A muscle-tendon vibratory stimulation device, MGV-1000-F (Uchida Electron Co., Ltd., Tokyo, Japan), was utilized to apply the vibratory stimulation.

Eligibility: Age-lower limit - 50 years-old = Gender - Male and Female Key inclusion criteria - Inclusion criteria were defined as patients with upper limb motor impairment after stroke and a Modified Ashworth Scale (MAS) score of 1 or higher in the flexor carpi radialis muscle. Key exclusion criteria - Exclusion criteria were as follows: participants with a FCR MAS score of 4, those unable to maintain the starting position of the examination due to joint range of motion limitations, those with upper limb motor disorders not caused by stroke, those with bilateral hemiplegia, those with a Hasegawa Dementia Scale Revised (HDS-R) score of 21 or lower, and those with superficial or deep sensory loss. Target Size - 25

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2024 Year 09 Month 04 Day Date of IRB - 2025 Year 01 Month 07 Day Anticipated trial start date - 2025 Year 01 Month 07 Day Last follow-up date - 2025 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067162

Disclaimer: Curated by HT Syndication.