UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027861 |
|---|---|
| Receipt number | R000031924 |
| Scientific Title | The effect of electrical nerve simulation for a post operative femoral neck fracture patient |
| Date of disclosure of the study information | 2017/06/22 |
| Last modified on | 2020/06/23 10:13:45 |
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Basic information
Public title
The effect of electrical nerve simulation for a post operative femoral neck fracture patient
Acronym
The effect of electrical nerve simulation for a post operative femoral neck fracture patient
Scientific Title
The effect of electrical nerve simulation for a post operative femoral neck fracture patient
Scientific Title:Acronym
The effect of electrical nerve simulation for a post operative femoral neck fracture patient
Region
| Japan |
Condition
Condition
post operative femoral neck fracture patients
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of electrical stimulation for post-operative femoral neck fracture
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
knee extensor of muscle strength
post ope 1day to 1 manth
Key secondary outcomes
gait
ADL
hospital stay (days)
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
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
electrical nerve stimulation
300 miccro sec
80Hz
maximum current strength to withstand
20min
Interventions/Control_2
only exercise
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
| 40 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
gait level higher than T-cane
Key exclusion criteria
dementia
gait disturbance
refuse of electrical nerve stimulation
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Mitsunori |
| Middle name | |
| Last name | Tokuda |
Organization
Heisei Memorial Hospital
Division name
Department of Rehabilitation
Zip code
6340813
Address
827 Shijyo-cho, Kashihara-city, Nara, 634-0813, JAPAN
TEL
0744-29-3300
tokuda.mitsunori@gmai.com
Public contact
Name of contact person
| 1st name | Mitsunori |
| Middle name | |
| Last name | Tokuda |
Organization
Heisei memorial Hospital
Division name
Department of Rehabilitation
Zip code
6340813
Address
827 Shijyo-cho, Kashihara-city, Nara, 634-0813, JAPAN
TEL
0744-29-3300
Homepage URL
tokuda.mitsunori@gmail.com
Sponsor or person
Institute
Heisei memorial Hospital
Institute
Department
Personal name
Funding Source
Organization
Heisei memorial Hospital
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
Heisei Memorial Hospital
Address
827 Shijyo-cho, Kashihara-city, Nara, 634-0813, JAPAN
Tel
0744293300
tokuda.mitsunori@gmail.com
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
| 2017 | Year | 06 | Month | 22 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/rigaku/advpub/0/advpub_11638/_pdf/-char/ja
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/rigaku/advpub/0/advpub_11638/_pdf/-char/ja
Number of participants that the trial has enrolled
82
Results
Training of the quadriceps using NMES from the next day following surgery in postoperative patients with femoral proximal fractures contributed to early improvement in knee extension muscle strength, early acquisition of gait and ADL independence, and improved gait ability at discharge.
Results date posted
| 2020 | Year | 06 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 04 | Month | 01 | Day |
Baseline Characteristics
The patients with proximal femoral fractures
Participant flow
post operation
Adverse events
None
Outcome measures
knee extension muscle strength, the Japanese Orthopedic Association (JOA) scores, and the number of days taken for gait and activities of daily living (ADL) to become independent.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2015 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2015 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 03 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 22 | Day |
Last modified on
| 2020 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031924
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
