UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000027861
Receipt No. 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 (Ver. 5)

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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
Email 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
Email tokuda.mitsunori@gmail.com

Sponsor
Institute Heisei memorial Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031924