UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of rehabilitation intervention using robotics knee orthosis
Title of the study (Brief title)	Evaluation of rehabilitation intervention using RKO
Region	Japan

Condition
Condition	cerebrovascular disease
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy of RKO for inpatients with cerebrovascular disease, and the safety of RKO and the characteristic of assist setting
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	10m walk fastest time
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	RKO intervention group Intervention period: 10 days
Interventions/Control_2	rko nonitervention group
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	20 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	* Brunnstrom stage: III to IV * Patinets can keep sitting squqre or standing position by watch or self-support (permission to use a staff) * Patients can perform assistance walk exercise with therapist
Key exclusion criteria	* Patients cannot use MIE owing to severe aphasia, apraxia, agnosia, dementia, sensory disturbance * Patients have difficult effort walk owing to hypertension, cardiovascular disease, respiratory disease, severe frailty
Target sample size	30

Research contact person
Name of lead principal investigator	kikuko ikeda
Organization	Tibatokushuukai hospital of okinawatokushuukai medical Corporation
Division name	Rehabilitation
Address	2-11-1 Takasudai Funabashi,Chiba Prefecture,Japan 274-0065
TEL	0474667111
Email	chiken@chibatoku.or.jp

Public contact
Name of contact person	takuya fujita
Organization	Tibatokushuukai hospital of okinawatokushuukai medical Corporation
Division name	Rehabilitation
Address	2-11-1 Takasudai Funabashi,Chiba Prefecture,Japan 274-0065
TEL	0474667111
Homepage URL
Email	chiken@chibatoku.or.jp

Sponsor
Institute	Tibatokushuukai hospital of okinawatokushuukai medical Corporation
Institute
Department

Funding Source
Organization	Tibatokushuukai hospital of okinawatokushuukai medical Corporation
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	2017 Year 01 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 20 Day
Anticipated trial start date	2016 Year 02 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 12 Month 21 Day
Last modified on	2018 Year 06 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028934