UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of the effect of rehabilitation intervention of robotics ankle orthosis on hemiplegia of cerebrovascular disorder
Title of the study (Brief title)	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	Kikuko Ikeda
Organization	CHIBA TOKUSHUKAI HOSPITAL
Division name	Department of Rehabilitation
Address	2-11-1 Takanedai,Fnabasi-shi, Chiba Japan
TEL	047-466-7111
Email	xgmny681@yahoo.co.jp

Public contact
Name of contact person	Dai Kawakita
Organization	CHIBA TOKUSHUKAI HOSPITAL
Division name	Department of Rehabilitation
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 08 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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