UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of task oriented training combined with electrical stimulation on hip abductor in patients with femoral neck fractrure.
Title of the study (Brief title)	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	Junji Nakamura
Organization	Nishiyamato Rehabilitaiton Hospital
Division name	Department of Rehabilitation Medicine
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	Junji Nakamura
Organization	Nishiyamato Rehabilitaiton Hospital
Division name	Department of Rehabilitation Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000035341