UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030958
Receipt number 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 09:32:46

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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 or person

Institute

Nishiyamato Rehabilitaiton Hospital

Institute

Department

Personal name



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

Value
https://center6.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