UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018648
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email tofuji@xc5.so-net.ne.jp

Sponsor
Institute Juntendo University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021593

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.