UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The influence that visual feedback gives in a knee extension muscular strength level
Title of the study (Brief title)	The influence that visual feedback gives in a knee extension muscular strength level
Region	Japan

Condition
Condition	stroke and weak elderly person
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
Primary outcomes	Isometric knee extension muscular strength level
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
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

Intervention
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
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

Research contact person
Name of lead principal investigator	Takuma Mogamiya
Organization	Department of Rehabilitation Medicine StMarianna University Yokohama City Seibu Hospital
Division name	Rehabilitation part
Address	1197-1, Yasashicho, Asahi-ku, Yokohama-shi, Kanagawa
TEL	045-366-1111
Email	hdmcj204@yahoo.co.jp

Public contact
Name of contact person	Takuma Mogamiya
Organization	Department of Rehabilitation Medicine StMarianna University Yokohama City Seibu Hospital
Division name	Rehabilitation part
Address	1197-1, Yasashicho, Asahi-ku, Yokohama-shi, Kanagawa
TEL	045-366-1111
Homepage URL
Email	hdmcj204@yahoo.co.jp

Sponsor
Institute	Department of Rehabilitation Medicine StMarianna University Yokohama City Seibu Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Department of Rehabilitation Medicine StMarianna University Yokohama City Seibu Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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	2016 Year 01 Month 06 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 07 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 07 Month 16 Day
Last modified on	2016 Year 07 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021226