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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030958
Receipt No. R000035341
Scientific Title The effect of task oriented training combined with electrical stimulation on hip abductor in patients with femoral neck fractrure.
Date of disclosure of the study information 2018/01/23
Last modified on 2018/12/13

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Basic information
Public title The effect of task oriented training combined with electrical stimulation on hip abductor in patients with femoral neck fractrure.
Acronym The effect of task oriented training combined with electrical stimulation in patients with femoral neck fractrure.
Scientific Title The effect of task oriented training combined with electrical stimulation on hip abductor in patients with femoral neck fractrure.
Scientific Title:Acronym The effect of task oriented training combined with electrical stimulation in patients with femoral neck fractrure.
Region
Japan

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

Objectives
Narrative objectives1 The purpose of this study is to preliminarily investigate the effect of task oriented training combined with electrical stimulation on hip abductor in patients with femoral neck fracture.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Force of hip abductor
walking ability
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment Other
Interventions/Control_1 task oriented training combined with electrical stimulation
Interventions/Control_2 task oriented 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
65 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria 1. First fracture
2.Gait level is higher than T-cane gait under supervision.
3.Walking was independent before fracture.
Key exclusion criteria 1. Dementia (Mini-Mental State Examination (MMSE)< 24)
2. Neurological disorders
3. Heart pacemaker
4. Sensitive skin.
5. Inability to give informed consent form.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junji Nakamura
Organization Nishiyamato Rehabilitaiton Hospital
Division name Department of Rehabilitation Medicine
Zip code
Address 3-2-2, Sasayuridai, Kanmaki-cho, Kitakatsuragi-gun, Nara
TEL 0745-71-6688
Email n.junji.0923@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Junji Nakamura
Organization Nishiyamato Rehabilitaiton Hospital
Division name Department of Rehabilitation Medicine
Zip code
Address 3-2-2, Sasayuridai, Kanmaki-cho, Kitakatsuragi-gun, Nara
TEL 0745-71-6688
Homepage URL
Email n.junji.0923@gmail.com

Sponsor
Institute Nishiyamato Rehabilitaiton Hospital
Institute
Department

Funding Source
Organization Japanese Society for Electrophysical Agents in Physical Therapy
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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 23 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2016 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 01 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 23 Day
Last modified on
2018 Year 12 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035341

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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