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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000030982
Receipt No. R000035371
Scientific Title The effect of gait training combined with electrical stimulation in patients with femoral neck fracture
Date of disclosure of the study information 2018/01/24
Last modified on 2019/02/23

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Basic information
Public title The effect of gait training combined with electrical stimulation in patients with femoral neck fracture
Acronym The effect of gait training combined with electrical stimulation
Scientific Title The effect of gait training combined with electrical stimulation in patients with femoral neck fracture
Scientific Title:Acronym The effect of gait training combined with electrical stimulation
Region
Japan

Condition
Condition Femoral neck fracture
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the effect of gait training combined with electrical stimulation on gluteus medius in patients with femoral neck fracture.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes gait ability
muscle strength of hip abductor
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment Other
Interventions/Control_1 gait training combined with electrical stimulation
two weeks
20 minutes
Interventions/Control_2 gait training only
two weeks
20 minutes
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
100 years-old >=
Gender Male and Female
Key inclusion criteria Patients after initial femoral neck fracture
Patients who can walk with more than supervision
Key exclusion criteria Mini Mental State Examination <21
Neurological disorders
Heart pacemaker
Severe heart disorders
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuya Takeda
Organization Kawamura Hospital
Division name Department of Rehabilitation
Zip code
Address 84-1, Daihannya, Akutami, Gifu, Gifu
TEL 058-241-3311
Email kazuya2271@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Kazuya Takeda
Organization Kawamura Hospital
Division name Department of Rehabilitation
Zip code
Address 84-1, Daihannya, Akutami, Gifu, Gifu
TEL 058-241-3311
Homepage URL
Email kazuya2271@gmail.com

Sponsor
Institute Kawamura Hospital
Institute
Department

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
Address
Tel
Email

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
2018 Year 01 Month 24 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 Terminated
Date of protocol fixation
2018 Year 01 Month 31 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 01 Month 24 Day
Last modified on
2019 Year 02 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035371

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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