UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficacy of stroke rehabilitation using engineering apparatus
Title of the study (Brief title)	stroke rehabilitation using engineering apparatus
Region	Japan

Condition
Condition	stroke patients
Classification by specialty	Neurology Neurosurgery Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this clinical study is to assess the efficacy of stroke rehabilitation using engineering apparatus.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Simple test for evaluating hand function at 4 weeks of rehabilitaion
Key secondary outcomes	modified Rankin Scale Brunnstrom Recovery Stage Modified Ashworth Scale Stroke Impairment Assessment Set Fugl-Meyer Assessment Barthel Index

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	Individual
Blinding	Open -but assessor(s) are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	control group:standard rehabilitation (40 minutes/day, 5 time/week, one month)
Interventions/Control_2	interventions:standard rehabilitation and rehabiritation using engineering apparatus (standaed rehabilitation(20 minutes) and rehabiritation using engineering apparatus(20 minutes)/day, 5 time/week, one month)
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	stroke patients for the first time
Key exclusion criteria	a patients with cognitive disfunction
Target sample size	56

Research contact person
Name of lead principal investigator	Isao Matsushita
Organization	Toyama university hospital
Division name	Department of rehabilitation
Address	2630 sugitani toyama
TEL	0760-434-7850
Email	matusita@med.u-toyama.ac.jp

Public contact
Name of contact person	koji Ishikuro
Organization	Toyama university hospital
Division name	Department of rehabilitation
Address	2630 sugitani toyama
TEL	076-434-7850
Homepage URL
Email	ishikuro@med.u-toyama.ac.jp

Sponsor
Institute	Toyama university 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	Toyama university hospital
Organization
Division
Category of Funding Organization	Other
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 05 Month 23 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 04 Month 28 Day
Anticipated trial start date	2016 Year 05 Month 23 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	2016 Year 05 Month 22 Day
Last modified on	2016 Year 05 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025746