Clinical Trial: A Pilot Randomized Controlled Trial to Evaluate the Efficacy of Belt Electrode-Skeletal Muscle Electrical Stimulation (B-SES) in Rehabilitation Following Proximal Femur Fracture Surgery (Japan)

Tokyo, Dec. 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060064) titled 'A Pilot Randomized Controlled Trial to Evaluate the Efficacy of Belt Electrode-Skeletal Muscle Electrical Stimulation (B-SES) in Rehabilitation Following Proximal Femur Fracture Surgery' on Dec. 12.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Gunma University

Condition: Condition - Proximal Femur Fracture Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to calculate the effect size when implementing B-SES in rehabilitation following proximal femoral fractures and to obtain foundational data for determining an appropriate sample size for the upcoming validation trial. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - In the B-SES group, B-SES is administered once daily, five days a week (Monday through Friday). Preparation and removal of the B-SES take 5 minutes, with a stimulation time of 15 minutes, totaling 20 minutes per session. Regarding rehabilitation time during the intervention period, the B-SES group will undergo 100 minutes of regular rehabilitation plus 20 minutes of B-SES on 5 days per week (Monday through Friday). On 2 days per week (Saturday and Sunday), they will undergo 120 minutes of regular rehabilitation. Interventions/Control_2 - The control group undergoes approximately 120 minutes of standard rehabilitation daily.

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1) Postoperative cases of proximal femur fractures in patients aged 20 years or older 2) Patients admitted to the Rehabilitation Ward at Fujioka General Hospital undergoing rehabilitation 3) Patients scheduled for hospitalization in the Rehabilitation Ward at Fujioka General Hospital for 4 weeks or longer 4) Patients who have provided written consent to participate in this study Key exclusion criteria - 1) Patients instructed by an orthopedic surgeon to avoid weight-bearing 2) Patients with concomitant fractures in other lower limb areas 3) Patients with cerebrovascular or neurological disorders 4) Patients with implanted electronic devices preventing B-SES implementation 5) Patients unable to communicate 6) Patients with skin abnormalities at belt electrode application sites 7) Patients with sensory impairment or hypersensitivity at the belt electrode application site 8) Upon admission to the recovery ward Blood test shows D-dimer over 10 and an increase from the previous measurement Clinical findings suggestive of lower extremity venous thrombosis Patients meeting both conditions and diagnosed with lower extremity venous thrombosis via lower extremity venous ultrasound or contrast-enhanced CT 9) Other patients deemed unsuitable for the study at the physician's discretio)n Target Size - 30

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 11 Month 28 Day Date of IRB - 2025 Year 11 Month 28 Day Anticipated trial start date - 2026 Year 01 Month 05 Day Last follow-up date - 2027 Year 06 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068694

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