UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060064 |
|---|---|
| Receipt number | R000068694 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2025/12/12 |
| Last modified on | 2025/12/12 12:11:58 |
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Basic information
Public title
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
Acronym
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
Scientific Title
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
Scientific Title:Acronym
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
Region
| Japan |
Condition
Condition
Proximal Femur Fracture
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hironori |
| Middle name | |
| Last name | Arii |
Organization
Gunma University Hospital
Division name
Division of Rehabilitation
Zip code
371-8511
Address
3-39-15,Showa town, Maebashi city, Gunma prefecture
TEL
0272208655
hiro-arii@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Hironori |
| Middle name | |
| Last name | Arii |
Organization
Gunma University Hospital
Division name
Division of Rehabilitation
Zip code
371-8511
Address
3-39-15, Showa town, Maebashi city, Gunma prefecture
TEL
0272208655
Homepage URL
hiro-arii@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Gunma University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Fujioka General Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma University Hospital Clinical Research Review Board
Address
3-39-15, Showa town, Maebashi city, Gunma prefecture
Tel
0272208740
gunmaciru-office@umin.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 12 | Month | 12 | Day |
Last modified on
| 2025 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068694
