UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056700 |
|---|---|
| Receipt number | R000064794 |
| Scientific Title | Effectiveness of Neuromuscular Electrical Stimulation in Patients undergoing Lower Extremity Revascularization Surgery. |
| Date of disclosure of the study information | 2025/01/14 |
| Last modified on | 2025/01/13 16:42:11 |
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Basic information
Public title
Investigation of the effect of electrical stimulation on patients undergoing lower limb revascularization surgery
Acronym
Investigation of the effect of electrical stimulation on patients undergoing lower limb revascularization surgery
Scientific Title
Effectiveness of Neuromuscular Electrical Stimulation in Patients undergoing Lower Extremity Revascularization Surgery.
Scientific Title:Acronym
Effectiveness of Neuromuscular Electrical Stimulation in Patients undergoing Lower Extremity Revascularization Surgery.
Region
| Japan |
Condition
Condition
Peripheral Arterial Disease
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effects of neuromuscular electrical stimulation on revascularization patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The test is the prolongation of walking distance in the 6-minute walk test after 3 months of treatment, and evaluates whether the neuromuscular electrical stimulation group is superior to the control group.
Key secondary outcomes
Physical activity at 3 and 12 months post-treatment will be evaluated to determine if improvement in physical activity was associated with prevention of restenosis.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The neuromuscular electrical stimulation group will receive neuromuscular electrical stimulation of the bilateral triceps muscles in addition to a program compliant with the usual rehabilitation program. Neuromuscular electrical stimulation was performed for 1 hour per day for 3 months. The frequency and pulse width are fixed at 50 Hz and 200 microseconds, respectively. The output should be set to 5 to 30 mA for safety reasons, and the stimulation should be performed within a pain tolerable range.
Interventions/Control_2
The control group will receive only the usual rehabilitation program.
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
Patients who required inpatient care for lower limb revascularization surgery and had a prescription for physical therapy.
Key exclusion criteria
Patients who could not be assessed for activities of daily living or physical function, who are not ambulatory independently, or who had to undergo reoperation due to postoperative events. In addition, the following are contraindications or prohibitions for POSTIM, a neuromuscular electrical stimulation device.
Patients with certain implantable electronic devices such as pacemakers, hematochezia, areas of moderate or greater edema, areas of sensory disturbance, patients with acute (painful) disease of unknown cause, patients with heart problems, patients with a high predisposition to bleeding, patients with malignant tumors, pregnant women, injured or inflamed skin areas, febrile disease patients with contagious diseases, patients with skin surface with venous irritation (veins protruding), patients with metal or plastic implants (artificial heads, implanted nails, etc.) in the body, patients who are at risk of thrombosis, venous thrombosis, varicose veins or other vascular disorders, patients on carotid sinus, and other patients deemed inappropriate by the physician.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Ogawa |
Organization
Aichi Medical University
Division name
Department of Rehabilitation Medicine
Zip code
480-1195
Address
1-1 Yazakokarimata, Nagakute,Aichi,
TEL
0561-62-3311
ogawa.takahiro.794@mail.aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Yamamoto |
Organization
Aichi Medical University Hospital
Division name
Department of Rehabilitation
Zip code
480-1195
Address
1-1 Yazakokarimata, Nagakute, Aichi, Japan
TEL
0561-62-3311
Homepage URL
yamamoto.masahiro.223@mail.aichi-med-u.ac.jp
Sponsor or person
Institute
Nihon Fukushi University
Institute
Department
Personal name
Masaharu Nakajima
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aichi Medical University Hospital
Address
1-1 Yazakokarimata, Nagakute, Aichi, Japan
Tel
0569-20-0111
amu_ethics@aichi-med-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2024-201
Org. issuing International ID_1
Aichi Medical University Hospital
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 | 01 | Month | 14 | 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
| 2024 | Year | 11 | Month | 27 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 14 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | 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 | 01 | Month | 13 | Day |
Last modified on
| 2025 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064794
