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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000026439
Receipt No. R000030369
Scientific Title Efficacy of the exercise using Balance Exercise Assist Robot for the postoperative patients with myelopathy
Date of disclosure of the study information 2017/06/01
Last modified on 2019/03/26

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Basic information
Public title Efficacy of the exercise using Balance Exercise Assist Robot for the postoperative patients with myelopathy
Acronym Efficacy of the exercise using Balance Exercise Assist Robot for the postoperative patients with myelopathy
Scientific Title Efficacy of the exercise using Balance Exercise Assist Robot for the postoperative patients with myelopathy
Scientific Title:Acronym Efficacy of the exercise using Balance Exercise Assist Robot for the postoperative patients with myelopathy
Region
Japan

Condition
Condition Myelopathy
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aim to examine the efficacy the exercise using Balance Exercise Assist Robot for the postoperative patients with myelopathy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Functional Reach Test
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 The intervention group receives 40 min of exercise using a Balance Exercise Assist Robot and 40 min of conventional physiotherapy per day for 18 days. Occupational therapy is performed for 40 minutes a day according to the upper extremity disorder.
Interventions/Control_2 The control group receives 40 min of conventional balance exercise and 40 min of conventional physiotherapy per day for 18 days. Occupational therapy is performed for 40 minutes a day according to the upper extremity disorder.
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
90 years-old >
Gender Male and Female
Key inclusion criteria Inclusion criteria is as follow: 1) the myelopathy patients performed surgery on spinal/spinal cord disease, 2) the patients who can walk using a walker without manual contact, 3) patients who can stop on Balance Exercise Assist Robot.
Key exclusion criteria Exclusion criteria is as following: 1) Difficulty in communication, 2) Patients have a risk to their health by exercise intensity.
Target sample size 36

Research contact person
Name of lead principal investigator
1st name Yasuo
Middle name
Last name Mikami
Organization Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name Department of Rehabilitation Medicine
Zip code 602-8566
Address 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, Japan
TEL 075-251-5324
Email reha@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name Suzuyo
Middle name
Last name Ohashi
Organization Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name Department of Rehabilitation Medicine
Zip code 602-8566
Address 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, Japan
TEL 075-251-5324
Homepage URL
Email reha@koto.kpu-m.ac.jp

Sponsor
Institute Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization Kyoto Prefectural University of Medicine
Toyota Motor Corporation
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 Kyoto Prefectural University of Medicine, Clinical Research Review Board
Address 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, Japan
Tel 075-251-5337
Email rinri@koto.kpu-m.ac.jp

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 06 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 Preinitiation
Date of protocol fixation
2017 Year 03 Month 07 Day
Date of IRB
Anticipated trial start date
2017 Year 06 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
2017 Year 03 Month 07 Day
Last modified on
2019 Year 03 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030369

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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