Clinical Trial: Effects of repetitive sit-to-stand self-exercise combined with neuromuscular electrical stimulation on bilateral quadriceps in hemiplegic patients in a convalescent rehabilitation ward: A randomized crossover study (Japan)

Tokyo, Feb. 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060710) titled 'Effects of repetitive sit-to-stand self-exercise combined with neuromuscular electrical stimulation on bilateral quadriceps in hemiplegic patients in a convalescent rehabilitation ward: A randomized crossover study' on Feb. 20.

Study Type: Interventional

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

Primary Sponsor: Institute - Kyushu University of Nursing and Social Welfare

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

Objective: Narrative objectives1 - The objective of this study is to investigate the effects of repetitive sit-to-stand self-exercise combined with neuromuscular electrical stimulation (NMES) on the bilateral quadriceps, in addition to conventional rehabilitation, on lower limb motor function, standing balance, and walking ability in hemiplegic patients admitted to a convalescent rehabilitation ward, using a randomized crossover design. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - conventional rehabilitation Period A: Conventional rehabilitation only (60 min/day). Duration: 2 weeks for each phase, with a 1-week washout period (5 weeks in total). Interventions/Control_2 - Repetitive sit-to-stand self-exercise combined with NMES, in addition to conventional rehabilitation Period B: Repetitive sit-to-stand exercise with NMES (1 set/day, 3 days/week) plus conventional rehabilitation (60 min/day). Duration: 2 weeks for each phase, with a 1-week washout period (5 weeks in total).

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - 1. Patients aged 18 to 85 years. 2. Patients admitted to the convalescent rehabilitation ward of our hospital (within 180 days after stroke onset). 3. Patients with their first-ever stroke, classified as either cerebral infarction or intracerebral hemorrhage. 4. Patients presenting with mild to moderate lower limb motor paralysis. 5. Patients with a Functional Ambulation Categories (FAC) score of 1 or higher. 6. Patients with stable systemic conditions, including blood pressure, pulse rate, and blood glucose levels. 7. Patients capable of providing written informed consent personally. Key exclusion criteria - 1. Patients with significant cognitive impairment that interferes with the execution of repetitive sit-to-stand exercise with NMES (Mini-Mental State Examination [MMSE] score of 23 points or less). 2. Patients with contraindications to electrical stimulation therapy, including cardiac pacemakers, pregnancy, malignant tumors, active bleeding sites, infections, or areas of inflammation. 3. Patients deemed unable to perform self-exercises due to exertional dyspnea, heart failure, arrhythmia, myocardial infarction, or other cardiovascular conditions. 4. Patients with a history of neurological or orthopedic diseases affecting trunk or lower limb function, or those with comorbidities (e.g., degenerative diseases, scoliosis) whose symptoms might be exacerbated by functional training. 5. Patients with severe hepatic impairment, renal impairment, or cardiovascular disease. 6. Patients with severe sensory impairment, ataxia, or higher brain dysfunction such as aphasia, which makes the execution of repetitive sit-to-stand exercise with NMES difficult. Target Size - 16

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 10 Month 28 Day Anticipated trial start date - 2026 Year 03 Month 01 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069456

Disclaimer: Curated by HT Syndication.