Tokyo, Oct. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063144) titled 'Neurophysiological Characteristics of Associated Reactions in Stroke Patients' on Oct. 15.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Non-randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - Kyoto University

Condition: Condition - Stroke (cerebral infarction or intracerebral hemorrhage); healthy adults (comparison groups) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To clarify the neurophysiological characteristics of associated reactions after stroke, by comparing muscle activity arising on the contralateral side and neurophysiological measures when the effort level of unilateral voluntary contraction is varied, among patients with hemiparesis after stroke, young healthy adults, and older healthy adults. Basic objectives2 - Others

Intervention: Interventions/Control_1 - Stroke group: Participants perform isometric elbow flexion and knee extension of the non-paretic side at 30%, 50%, and 70% of maximum voluntary contraction (MVC) (condition order randomized for each participant; 20 trials per condition; torque increased over approximately 2-3 s and held for 6 s; 60-s rest between trials), with simultaneous EEG and EMG recording. In addition, a voluntary matching task (20 trials) is performed, in which participants voluntarily activate the paretic muscle (biceps brachii or rectus femoris) to match the EMG amplitude of the associated reaction elicited under the 70% MVC condition. Measurements are divided over 3 days (day 1: assessments; day 2: elbow flexion task; day 3: knee extension task) and completed within 1 week after consent. Interventions/Control_2 - Young healthy group: Participants perform isometric elbow flexion and knee extension of the non-dominant side at 30%, 50%, and 70% MVC (order of tasks and conditions randomized for each participant; 20 trials per condition; torque increased over approximately 2-3 s and held for 6 s; 30-s rest between trials), with simultaneous EEG and EMG recording. Measurements are completed in 1 day (approximately 140 min including rest).

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - [Stroke group] 1) Aged 60 to 85 years 2) Hemiparesis of the upper and lower limbs due to a first-ever unilateral supratentorial cerebral infarction or intracerebral hemorrhage 3) At least 1 month after stroke onset 4) Stable general condition 5) Able to understand the study explanation and task instructions and to perform the tasks 6) Able to participate in measurements of up to approximately 100 min per day, including rest 7) Medical clearance for study participation obtained from the attending physician (or the full-time physician at the geriatric health services facility) [Young healthy group] [Stroke group] 1) Aged 60 to 85 years 2) Hemiparesis of the upper and lower limbs due to a first-ever unilateral supratentorial cerebral infarction or intracerebral hemorrhage 3) At least 1 month after stroke onset 4) Stable general condition 5) Able to understand the study explanation and task instructions and to perform the tasks 6) Able to participate in measurements of up to approximately 100 min per day, including rest 7) Medical clearance for study participation obtained from the attending physician (or the full-time physician at the geriatric health services facility) [Young healthy group] 1) Healthy individuals aged 18 to 30 years 2) Right-handed according to the Edinburgh Handedness Inventory 3) Right-footed according to the Waterloo Footedness Questionnaire-Revised [Older healthy group] 1) Healthy individuals aged 60 to 85 years 2) Right-handed according to the Edinburgh Handedness Inventory 3) Right-footed according to the Waterloo Footedness Questionnaire-Revised Key exclusion criteria - [Stroke group] 1) Mini-Mental State Examination (MMSE) score of 20 or less recorded in the medical record, or judged to have difficulty sufficiently understanding the study explanation or task instructions due to aphasia or other higher brain dysfunction 2) Respiratory or cardiovascular disease that makes it difficult to perform the motor tasks safely 3) Limitation in range of motion that affects task performance 4) Persistent or repetitive involuntary movements of the limbs or trunk at rest that are judged to affect EEG or EMG recording or analysis 5) Botulinum toxin injection into the upper or lower limb, including the target muscles, within 4 months before the date of consent [Young and older healthy groups] 1) Central nervous system, neuromuscular, or orthopedic disease that affects task performance or neurophysiological assessment 2) Respiratory or cardiovascular disease that makes it difficult to perform the motor tasks safely 3) Use of central nervous system-acting drugs that may affect neurophysiological assessment 4) Current psychiatric disorder that makes study participation or task performance difficult 5) Currently engaged, or engaged within the past year, in specialized or competitive training in a specific sport (training at least 3 times per week for a cumulative period of at least 1 year, or activity as a competitive athlete) Target Size - 75

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 10 Month 01 Day Anticipated trial start date - 2026 Year 11 Month 01 Day Last follow-up date - 2030 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072276

Disclaimer: Curated by HT Syndication.