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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033245
Receipt No. R000037904
Official scientific title of the study Comprehensive study for rehabilitation with robot suits and the three demensional motion analysis system.
Date of disclosure of the study information 2018/07/04
Last modified on 2018/07/02

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Basic information
Official scientific title of the study Comprehensive study for rehabilitation with robot suits and the three demensional motion analysis system.
Title of the study (Brief title) Comprehensive rehabilitation study with robot suits
Region
Japan

Condition
Condition Spinal cord injury, stroke, neuro-muscular disease,disuse syndrome
Classification by specialty
Medicine in general Neurology Surgery in general
Orthopedics Neurosurgery Rehabilitation medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To exmaine the safety and effectiveness of rehabilitation with robot suits HAL for the conditions such as spinal cord injury, stroke, neuro-muscular disease,and disuse syndrome.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Basic mobility and gait function examined by the three dementional motional analysis for the baseline, 2weeks after, 4weeks after, and 8weeks after the intervention.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
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
Other
Interventions/Control_1 rehabilitation with robot suits HAL
Frequency of intervention:1-10 times (as needed)
Interventions/Control_2 General rehabilitation
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
15 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria Patients with the weakness of lower limb(s) due to spinal cord injury, stroke, neuro-muscular disease, or disuse syndrome.
Key exclusion criteria Patients who cannot engage in physical exercises due to other diseases or patients who cannot follow the exercise instruction due to cognitive impairments.
Target sample size 50

Research contact person
Name of lead principal investigator Shinoda Yusuke
Organization The University of Tokyo Hospital
Division name Rehabilitation Center
Address Hongo 7-3-1 Bunkyo-ku Hongo Tokyo
TEL 03-5800-8680
Email yshinoda-tky@umin.ac.jp

Public contact
Name of contact person Hasegawa Masato
Organization The University of Tokyo Hospital
Division name Rehabilitation Center
Address Hongo 7-3-1 Bunkyo-ku Hongo Tokyo
TEL 03-5800-8680
Homepage URL
Email hasegawam-reh@h.u-tokyo.ac.jp

Sponsor
Institute The University of Tokyo Hospital
Institute
Department

Funding Source
Organization The University of Tokyo Hospital
Organization
Division
Category of Funding Organization Self funding
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 07 Month 04 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2016 Year 04 Month 01 Day
Anticipated trial start date
2016 Year 04 Month 01 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 07 Month 02 Day
Last modified on
2018 Year 07 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037904

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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