UMIN-CTR Clinical Trial

Public title

The influence that visual feedback gives in a knee extension muscular strength level

Acronym

The influence that visual feedback gives in a knee extension muscular strength level

Scientific Title

The influence that visual feedback gives in a knee extension muscular strength level

Scientific Title:Acronym

The influence that visual feedback gives in a knee extension muscular strength level

Region

Japan

Condition

stroke and weak elderly person

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Consider whether the knee extension muscular strength of an elderly person and the cerebral damage patient produces a difference by having visual feedback or not. In addition, examine stigmata and the characteristic of the cognitive function to affect the difference of the muscular strength level.

Basic objectives2

Others

Basic objectives -Others

Validity, difference

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Isometric knee extension muscular strength level

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Open -no one is blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

I measure isometric knee extension muscular strength without using visual feedback.

Interventions/Control_2

I measure isometric knee extension muscular strength using visual feedback.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

100

years-old

>=

Gender

Male and Female

Key inclusion criteria

Our House inpatient whom there is a request of the rehabilitation than a doctor and undergoes rehabilitation with the goal of improvement of the muscular strength and intervenes in.
A stroke patient and a weak elderly patient.
The patient whom there is not of science views to suggest a person without the past of a knee joint disease and cancer, a knee joint ache and inflammation of the knee joint such as a feeling of heat, swelling, the flare on carrying out the isometric knee extension muscular strength measurement.
The patient whom I can recognize measurements of the muscular strength measuring equipment, and a procedure of the muscular strength measurement can understand. About the recognition of measurements, I show the indication of measurements and judge it whether you can call out time exactly.
The patient that an agreement by the free will of a patient or the family was provided after understanding enough after having received enough explanation on participating of the final examination
The patient who is stable in its condition of a patien

Key exclusion criteria

The patient who is not stable in its condition of a patient
The person that understanding and an agreement are not provided by the person or a family for participation of the final examination
The patient whom it was judged an examination responsibility doctor or an examination allotment doctor to be inappropriate as a subject

Target sample size

120

Name of lead principal investigator

1st name
Middle name
Last name	Takuma Mogamiya

Organization

Department of Rehabilitation Medicine StMarianna University Yokohama City Seibu Hospital

Division name

Rehabilitation part

Zip code

Address

1197-1, Yasashicho, Asahi-ku, Yokohama-shi, Kanagawa

TEL

045-366-1111

Email

hdmcj204@yahoo.co.jp

Name of contact person

1st name
Middle name
Last name	Takuma Mogamiya

Organization

Department of Rehabilitation Medicine StMarianna University Yokohama City Seibu Hospital

Division name

Rehabilitation part

Zip code

Address

1197-1, Yasashicho, Asahi-ku, Yokohama-shi, Kanagawa

TEL

045-366-1111

Homepage URL

Email

hdmcj204@yahoo.co.jp

Institute

Department of Rehabilitation Medicine StMarianna University Yokohama City Seibu Hospital

Institute

Department

Personal name

Organization

Department of Rehabilitation Medicine StMarianna University Yokohama City Seibu Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

01

Month

06

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Terminated

Date of protocol fixation

2015

Year

07

Month

01

Day

Date of IRB

Anticipated trial start date

2016

Year

01

Month

07

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

07

Month

16

Day

Last modified on

2016

Year

07

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021226