Tokyo, Feb. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060662) titled 'Verification of the effectiveness of combined therapy of exercise therapy and repetitive peripheral magnetic stimulation (rPMS) for improving lower limb function and movement in convalescent stroke patients; randomized crossover trial' on Feb. 15.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - others

Condition: Condition - Patients aged 40 or older to younger than 65 Patients admitted to our hospital's rehabilitation ward for rehabilitation treatment within 60 days of stroke onset Patients who have had a first stroke and the type of stroke is unilateral cerebral infarction or cerebral hemorrhage Patients with mild to moderate lower limb motor paralysis (Brunnstrom stage 3/4/5) Patients with a degree of gait disorder with a Functional Ambulation Categories (FAC) score of 3/4 Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To clarify the effects of combined therapy of exercise therapy and repetitive peripheral magnetic stimulation (rPMS) on motor paralysis of the lower limbs of stroke patients with hemiplegia admitted to a convalescent rehabilitation ward. With the medical environment demanding efficiency, explore the possibility of providing more effective exercise therapy and responding to early expansion of activities of daily living (ADL). Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Conventional rehabilitation and rPMS combination program Interventions/Control_2 - Conventional rehabilitation

Eligibility: Age-lower limit - 40 years-old

Gender - Male and Female Key inclusion criteria - Patients aged 40 or older to younger than 65 Patients admitted to our hospital's rehabilitation ward for rehabilitation treatment within 60 days of stroke onset Patients who have had a first stroke and the type of stroke is unilateral cerebral infarction or cerebral hemorrhage Patients with mild to moderate lower limb motor paralysis (Brunnstrom stage 3 to 5) Patients with a degree of gait disorder with a Functional Ambulation Categories (FAC) score of 3 to 4 Key exclusion criteria - Patients with metal implants or implant devices (e.g. cardiac pacemaker) within the stimulation site Pregnant patients Patients with or history of epilepsy Patients whose general conditions such as blood pressure, pulse rate, and blood sugar levels are unstable due to dyspnea on exertion, heart failure, arrhythmia, myocardial infarction, etc., and who are judged to have difficulty in functional training. Patients with a history of neurological diseases or orthopedic diseases that affect trunk and lower extremity function *Patients with comorbid diseases such as degenerative diseases, scoliosis, osteoporosis, etc. whose symptoms are judged to be aggravated by functional training Patients with subarachnoid hemorrhage, severe liver disorder, renal disorder, or cardiovascular disease Patients with higher brain dysfunction such as severe sensory impairment, ataxia, or aphasia Patients who do not have the capacity to consent themselves as research subjects Patients whose attending physician has determined that they are unable to participate in this study, taking into account their general condition. Target Size - 20

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 10 Month 08 Day Date of IRB - 2025 Year 11 Month 26 Day Anticipated trial start date - 2026 Year 01 Month 18 Day Last follow-up date - 2027 Year 11 Month 26 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068924

Disclaimer: Curated by HT Syndication.