UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030581 |
|---|---|
| Receipt number | 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 | 2020/12/28 17:38:38 |
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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 | Seiji |
| Middle name | |
| Last name | Etoh |
Organization
Kagoshima University Hospital
Division name
Department of physical medicine and rehabilitation,
Zip code
890-8520
Address
8-35-1, Sakuragaoka, Kagoshima city
TEL
0992755339
etohs@m2.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Seiji |
| Middle name | |
| Last name | Etoh |
Organization
Kagoshima University Hospital
Division name
Department of physical medicine and rehabilitation
Zip code
890-8520
Address
8-35-1, Sakuragaoka, Kagoshima city
TEL
0992755339
Homepage URL
etohs@m2.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kagoshima University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
, Kagoshima
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Guraduate school of Kagoshima University
Address
8-35-1, Sakuragaoka, Kagoshima city
Tel
0992755339
etohs@m2.kufm.kagoshima-u.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 | 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
| 2017 | Year | 11 | Month | 27 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 28 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 05 | Month | 31 | Day |
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
| 2020 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034920
