UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033809
Receipt number R000038566
Scientific Title Examination of the effect of rehabilitation intervention of robotics ankle orthosis on hemiplegia of cerebrovascular disorder
Date of disclosure of the study information 2018/08/25
Last modified on 2018/08/22 17:13:12

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Basic information

Public title

Examination of the effect of rehabilitation intervention of robotics ankle orthosis
on hemiplegia of cerebrovascular disorder

Acronym

Examination of the effect of intervention of robotics ankle orthosis

Scientific Title

Examination of the effect of rehabilitation intervention of robotics ankle orthosis
on hemiplegia of cerebrovascular disorder

Scientific Title:Acronym

Examination of the effect of intervention of robotics ankle orthosis

Region

Japan


Condition

Condition

Stroke

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The objective is to investigate the adaptive symptoms of the robotics ankle orthosis and the characteristics of the setting by comparing the practicing effect with the group with the robotics ankle orthosis applied to the hemiplegic patients as compared with the non-treated group .

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I


Assessment

Primary outcomes

10m walking time

Key secondary outcomes

Brunstrom recovery stege
Functional independence measure
Amount of assistance for transfer and walking and types of auxiliary tool
Sensory disorders of lower limbs of SIAS
Walking practice distance at the time of intervention
Assist setting and mounting time of robotics ankle orthosis
Overlapping walking distance
Stride length
Paralyzed side standing leg time on walking
Angle of hip joint, knee joint, ankle joint during walking
Passionately and automatic ankle dorsiflexion angle


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Device,equipment

Interventions/Control_1

Walking training using a robotics ankle orthosis

Interventions/Control_2


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


Not applicable

Gender

Male and Female

Key inclusion criteria

Cerebrovascular disorder Hemiplegic patients

Key exclusion criteria

Severe aphasia, apraxia, dizziness, dementia, sensory disturbance.
Patients who are difficult to walk with one's assistance.

Target sample size

12


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kikuko Ikeda

Organization

CHIBA TOKUSHUKAI HOSPITAL

Division name

Department of Rehabilitation

Zip code


Address

2-11-1 Takanedai,Fnabasi-shi, Chiba Japan

TEL

047-466-7111

Email

xgmny681@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Dai Kawakita

Organization

CHIBA TOKUSHUKAI HOSPITAL

Division name

Department of Rehabilitation

Zip code


Address

2-11-1 Takanedai,Fnabasi-shi, Chiba Japan

TEL

047-466-7111

Homepage URL


Email

xgmny681@yahoo.co.jp


Sponsor or person

Institute

CHIBA TOKUSHUKAI HOSPITAL

Institute

Department

Personal name



Funding Source

Organization

CHIBA TOKUSHUKAI HOSPITAL

Organization

Division

Category of Funding Organization

Other

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

2018 Year 08 Month 25 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

Preinitiation

Date of protocol fixation

2018 Year 08 Month 01 Day

Date of IRB


Anticipated trial start date

2018 Year 08 Month 20 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

2018 Year 08 Month 20 Day

Last modified on

2018 Year 08 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038566


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name