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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033809
Receipt No. 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

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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
Institute CHIBA TOKUSHUKAI HOSPITAL
Institute
Department

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
URL(English) https://upload.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


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