UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019295 |
|---|---|
| Receipt number | R000021773 |
| Scientific Title | Clinical studies on the effects of intervention of neuroscience-based physical therapy on patients with stroke |
| Date of disclosure of the study information | 2015/11/01 |
| Last modified on | 2019/03/26 09:13:55 |
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Basic information
Public title
Clinical studies on the effects of intervention of neuroscience-based physical therapy on patients with stroke
Acronym
Clinical studies on stroke patients
Scientific Title
Clinical studies on the effects of intervention of neuroscience-based physical therapy on patients with stroke
Scientific Title:Acronym
Clinical studies on stroke patients
Region
| Japan |
Condition
Condition
Patients with stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of kinesthetic illusion induced by visual stimulation on recovery of hemiparesis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle force, Electromyography, Simple test for evaluating hand function (STEF), Fugl-Meyer Assessment (FMA)
Key secondary outcomes
Sensorimotor function (measured using Kinestage), Brunnstrom stage, Action Research Arm Test(ARAT)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Participants are presented visual stimuli which evoke kinesthetic illusion 20minutes a day for 10 days, in addition to a regular rehabilitation protocol for upper limb (A). Participants undergo a regular rehabilitation for upper limb for 10 days (B).
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
Participants should meet the following requirements.
1) Stroke patients who are judged not to have negative risks in participating in the experiment by the physician in charge.
2) Who provides a written informed consent to participate in the experiment.
3) Who does not have cognitive disorders (the score of MMSE should be higher than 21 points)
Key exclusion criteria
Who cannot comfortably sit on a chair for 20 minutes.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Fuminari |
| Middle name | |
| Last name | Kaneko |
Organization
Keio University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjyuku, Tokyo, Japan
TEL
+81-3-5363-3833
f-kaneko@keio.jp
Public contact
Name of contact person
| 1st name | Megumi |
| Middle name | |
| Last name | Okawada |
Organization
Keio University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjyuku, Tokyo, Japan
TEL
+81-3-5363-3833
Homepage URL
m-okawada@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Japan agency for medical research and development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Medical University
Address
17-1 jyonishi, Cyuou-ku,Sapporo
Tel
011-611-2111
rinri@sapmed.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
医療法人社団進和会旭川リハビリテーション病院（北海道）
医療法人社団豊生会東苗穂病院（北海道）
医療法人社団明芳会イムス板橋リハビリテーション病院（東京都）
茨城県立医療大学医科学センター（茨城県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 11 | Month | 22 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 09 | Day |
Last modified on
| 2019 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021773
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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