Tokyo, Oct. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059248) titled 'A Study on the Suppression of Spasticity by Vibration Stimulation' on Sept. 30.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Single blind -investigator(s) and assessor(s) are blinded Control - Placebo

Primary Sponsor: Institute - Fujita Health University

Condition: Condition - stroke Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Spasticity is defined as a velocity-dependent increase in muscle tone accompanied by hyperreflexia. Clinical findings include increased resistance during passive movement, hyperreflexia, and clonus. Spasticity is observed in many patients after cerebrovascular disorders and impedes activities of daily living, making appropriate spasticity assessment and treatment crucial. Vibration stimulation is one treatment for spasticity, with numerous reports on its efficacy. However, there is no consensus on optimal conditions such as frequency, amplitude, or duration of vibration stimulation. It is necessary to clarify effective stimulation conditions within a short timeframe.Many reports use the Modified Ashworth Scale (MAS) to assess the effectiveness of vibration stimulation, which involves judging the resistance felt when manually moving the target joint on a 6-point scale. However, the MAS procedure is ambiguous, and the low reliability of MAS evaluation results is a concern. Quantitative evaluation is necessary to appropriately assess spasticity and clarify treatment effects.The purpose of this study is to use quantitative evaluation to analyze in detail the spasticity-suppressing effects of vibration stimulation and to clarify the optimal stimulation settings. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Subjects capable of undergoing three-dimensional motion analysis and the 10m walking test shall undergo these gait assessments. Measure the subject's maximum ankle dorsiflexion angle. Position the subject in a reclining wheelchair and ensure they remain at rest. The subject's posture shall be set with the hip joint at 45 degrees of flexion and the knee joint at 60 degrees of flexion. Attach the iQMoS to the subject's foot. Using the spasticity measurement device, move the subject's ankle joint twice each at low speed (5 degrees/second) and high speed (300degrees/second) up to the maximum dorsiflexion angle measured in step 1. Remove the spasticity measurement device. Condition 1: Apply low-frequency (30Hz), high-amplitude (2-4mm) vibration stimulation using the Power Plate pro5. Immediately after vibration stimulation, repeat steps 1 through 6. Subsequently, repeat steps 1 through 6 to confirm the duration of effect. Interventions/Control_2 - Subjects capable of undergoing three-dimensional motion analysis and the 10m walking test shall undergo these gait assessments. Measure the subject's maximum ankle dorsiflexion angle. Position the subject in a reclining wheelchair and ensure they remain at rest. The subject's posture shall be set with the hip joint at 45 degrees of flexion and the knee joint at 60 degrees of flexion. Attach the iQMoS to the subject's foot. Using the spasticity measurement device, move the subject's ankle joint twice each at low speed (5 degrees/second) and high speed (300degrees/second) up to the maximum dorsiflexion angle measured in step 1. Remove the spasticity measurement device. Apply low-frequency (91Hz) vibration stimulation with an amplitude of 1.0mm using the Handheld Massager MD-001S Immediately after vibration stimulation, repeat steps 1 through 6. Subsequently, repeat steps 1 through 6 to confirm the duration of effect.

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Individuals who, after receiving full explanation and with full understanding, provided written consent of their own free will to participate in this study Individuals diagnosed with central nervous system disorders Key exclusion criteria - Individuals with unstable general condition Individuals unable to understand instructions due to impaired consciousness or severe aphasia Individuals with a history of orthopedic disorders in the ankle joint Individuals with passive ankle dorsiflexion range of motion less than 0 degrees Individuals deemed inappropriate by the principal investigator or co-investigator Target Size - 180

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 05 Month 20 Day Date of IRB - 2025 Year 05 Month 20 Day Anticipated trial start date - 2025 Year 05 Month 20 Day Last follow-up date - 2030 Year 10 Month 05 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067768

Disclaimer: Curated by HT Syndication.