UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026439 |
|---|---|
| Receipt number | 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 | 2020/01/31 11:43:08 |
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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
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
reha@koto.kpu-m.ac.jp
Sponsor or person
Institute
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Institute
Department
Personal name
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
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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 03 | Month | 07 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 13 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 31 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
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
| 2020 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030369
