UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036558 |
|---|---|
| Receipt number | R000041583 |
| Scientific Title | Effect of belt electrode skeletal muscle electrical stimulation (B-SES) on leg function and ambulatory state during the bed rest period after surgery for diabetic foot patients. |
| Date of disclosure of the study information | 2019/04/21 |
| Last modified on | 2022/04/26 12:36:35 |
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Basic information
Public title
Effect of belt electrode skeletal muscle electrical stimulation (B-SES) on leg function and ambulatory state during the bed rest period after surgery for diabetic foot patients.
Acronym
Effects of belt electrode skeletal muscle electrical stimulation (B-SES) on diabetic foot patients
Scientific Title
Effect of belt electrode skeletal muscle electrical stimulation (B-SES) on leg function and ambulatory state during the bed rest period after surgery for diabetic foot patients.
Scientific Title:Acronym
Effects of belt electrode skeletal muscle electrical stimulation (B-SES) on diabetic foot patients
Region
| Japan |
Condition
Condition
Diabetic Foot
Peripheral Arterial Disease
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of belt electrode skeletal muscle electrical stimulation (B-SES) on leg function and ambulatory state during the bed rest period after surgery for diabetic foot patients.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Range of Motion (Ankle Joint)
Key secondary outcomes
Lower limb strength
Ambulatory State
Size of wounds
Plantar load of walking
Physical activities (IPAQ)
QOL(EQ-5D-5L)
Skin Perfusion Pressure
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
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 addition to rehabilitation mainly consisted of ROMex and Strength Training, B-SES is applied on bilateral lower limbs.
Interventions/Control_2
Rehabilitation mainly consisted of ROMex and Strength Training.
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)admitted to the hospital for treatment of diabetic foot ulcers or ischemic ulcers
2)ambulated until one week before hospitalization
3)wound infections were controlled
Key exclusion criteria
1)underwent major amputation.
2)worsened lower limb symptom or general condition of patients due to postoperative complications.
3)other coexisting diseases which made rehabilitation more difficult (or long term hospitalization)
4) patients who do not agree to this study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Shinsuke |
| Middle name | |
| Last name | Imaoka |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Community-based Rehabilitation Sciences
Zip code
852-8102
Address
1-7-1 Sakamoto Nagasaki
TEL
095-819-7994
ptssinnsukeimaoka@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Shinsuke |
| Middle name | |
| Last name | Imaoka |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Community-based Rehabilitation Sciences
Zip code
852-8102
Address
1-7-1 Sakamoto Nagasaki
TEL
095-819-7994
Homepage URL
ptssinnsukeimaoka@yahoo.co.jp
Sponsor or person
Institute
Nagasaki University Graduate School of Biomedical Sciences
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Graduate School of Biomedical Sciences
Address
1-7-1 Sakamoto Nagasaki
Tel
095-819-7994
ptssinnsukeimaoka@yahoo.co.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
| 2019 | Year | 04 | Month | 21 | 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
Main results already published
Date of protocol fixation
| 2019 | Year | 03 | Month | 16 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 04 | Month | 21 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 04 | Month | 20 | Day |
Last modified on
| 2022 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041583
