UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025354
Receipt number 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 18:39:37

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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 or person

Institute

Tibatokushuukai hospital of okinawatokushuukai medical Corporation

Institute

Department

Personal name



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

Value
https://center6.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