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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025354
Receipt No. R000028934
Scientific Title Evaluation of rehabilitation intervention using robotics knee orthosis
Date of disclosure of the study information 2017/01/01
Last modified on 2018/06/23

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Basic information
Public title Evaluation of rehabilitation intervention using robotics knee orthosis
Acronym Evaluation of rehabilitation intervention using RKO
Scientific Title Evaluation of rehabilitation intervention using robotics knee orthosis
Scientific Title:Acronym 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
1st name
Middle name
Last name kikuko ikeda
Organization Tibatokushuukai hospital of okinawatokushuukai medical Corporation
Division name Rehabilitation
Zip code
Address 2-11-1 Takasudai Funabashi,Chiba Prefecture,Japan 274-0065
TEL 0474667111
Email chiken@chibatoku.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name takuya fujita
Organization Tibatokushuukai hospital of okinawatokushuukai medical Corporation
Division name Rehabilitation
Zip code
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)

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
2017 Year 01 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 01 Month 20 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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