UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018648 |
|---|---|
| Receipt number | R000021593 |
| Scientific Title | The effect of HANDS therapy among outpatients with chronic hemiparesis: Randomized control study |
| Date of disclosure of the study information | 2015/08/13 |
| Last modified on | 2020/06/25 13:41:20 |
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Basic information
Public title
The effect of HANDS therapy among outpatients with chronic hemiparesis: Randomized control study
Acronym
HANDS therapy for outpatients
Scientific Title
The effect of HANDS therapy among outpatients with chronic hemiparesis: Randomized control study
Scientific Title:Acronym
HANDS therapy for outpatients
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to study the effect of HANDS therapy among outpatients with chronic heiparesis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Fugl-Meyer Assessment
Key secondary outcomes
Mortor activity log
Box and block test
MAS
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
HANDS therapy for 4weeks, 8hours a day and Subthreshold Electrical stimulation with HANDS system for 4weeks, 8hours a day
Interventions/Control_2
Subthreshold Electrical stimulation with HANDS system for 4weeks, 8hours a day and HANDS therapy for 4weeks, 8hours a day
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Time from stroke onset >5month
No cognitive deficit
No severe proprooceptive deficit
No severe contracture in paretic hand
Muscle contraction was detected inparetic finger extensor
Independen for locomotion
Key exclusion criteria
Severe heart failurre
Severe pulmonary dysfunction
Severe hypertension
Uncontrolled seizure
Pace maker and other implanted
Other serious medical condition
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiyuki Fujiwara |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
Address
2-1-1 Hongo, Bunkyo, Tokyo 113-8421 Japan
TEL
03-3813-3111
tofuji@xc5.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiyuki Fujiwara |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
Address
2-1-1 Hongo, Bunkyo, Tokyo 113-8421, Japan
TEL
03-3813-3111
Homepage URL
tofuji@xc5.so-net.ne.jp
Sponsor or person
Institute
Juntendo University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
東海大学医学部付属病院（神奈川県）順天堂大学医学部附属病院順天堂医院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 13 | 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
Completed
Date of protocol fixation
| 2014 | Year | 09 | Month | 03 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 03 | Day |
Anticipated trial start date
| 2014 | Year | 11 | Month | 26 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 12 | Day |
Last modified on
| 2020 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021593
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
