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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030581
Receipt No. R000034920
Scientific Title The effect of exercise of unaffected upper limb with physiotherapy in stroke patients
Date of disclosure of the study information 2017/12/28
Last modified on 2017/12/26

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Basic information
Public title The effect of exercise of unaffected upper limb with physiotherapy in stroke patients
Acronym Exercise of unaffected upper limb with pysiotherapy
Scientific Title The effect of exercise of unaffected upper limb with physiotherapy in stroke patients
Scientific Title:Acronym Exercise of unaffected upper limb with pysiotherapy
Region
Japan

Condition
Condition stroke
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To confirm the effect of the exercise of unaffected hand
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the change of intracortical inhibition
Key secondary outcomes motor threshold
pinch force
drawing circle.
acceleration of finger

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 participants have the exercise that induce light fatigue.
the exercise of upper limb (10 min)
rehabilitaion of upper limb (40 min)
Interventions/Control_2 participants have the exercise that do not induce light fatigue.
the exercise of upper limb (10 min)
rehabilitaion of upper limb (40 min)
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
16 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria stroke patients
Brunnstrom stage of upper limb no less than 3
Participants can pinch movement by thum and index finger.
inpatients and out patinets of Kagoshima University Hospital
Key exclusion criteria patients with metalic implant, pacemaker etc.
patinets with severe disorder of higher brain function
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Seiji Etoh
Organization Kagoshima University Hospital
Division name Department of physical medicine and rehabilitation,
Zip code
Address Kirishima-City, Kagoshima, Japan
TEL 0995-78-2538
Email etohs@m2.kufm.kagoshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Seiji Etoh
Organization Kagoshima University Hospital
Division name Department of physical medicine and rehabilitation
Zip code
Address Kirishima-City, Kagoshima, Japan
TEL 0995-78-2538
Homepage URL
Email etohs@m2.kufm.kagoshima-u.ac.jp

Sponsor
Institute Kagoshima University Hospital
Institute
Department

Funding Source
Organization Kagoshima University Hospital
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
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

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 28 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 12 Month 26 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 28 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 12 Month 26 Day
Last modified on
2017 Year 12 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034920

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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