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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

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 - 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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000060064
Enrollment
30
Registered
2025-12-12
Start date
2026-01-05
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Proximal Femur Fracture

Interventions

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

Sponsors

Gunma University
Lead Sponsor
Fujioka General Hospital
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
The primary endpoint is the change in walking speed (value at 4 weeks after admission to the rehabilitation ward minus the value at admission to the rehabilitation ward).

Countries

Japan

Contacts

Public ContactHironori Arii

Gunma University Hospital Division of Rehabilitation

hiro-arii@gunma-u.ac.jp0272208655

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026