UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015287 |
|---|---|
| Receipt number | R000017777 |
| Scientific Title | Development of the system of the clinical motion analysis of the ADL activity related upper extremity in patients with hemiparetic stroke. |
| Date of disclosure of the study information | 2014/10/01 |
| Last modified on | 2017/04/25 08:53:55 |
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Basic information
Public title
Development of the system of the clinical motion analysis of the ADL activity related upper extremity in patients with hemiparetic stroke.
Acronym
Development of the system of the motion analysis of the ADL in patients with hemiparetic stroke.
Scientific Title
Development of the system of the clinical motion analysis of the ADL activity related upper extremity in patients with hemiparetic stroke.
Scientific Title:Acronym
Development of the system of the motion analysis of the ADL in patients with hemiparetic stroke.
Region
| Japan |
Condition
Condition
STROKE
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1.To build a motion analysis system to evaluate the ADL activity related upper extremity,folding a towel, carrying a cup to the mouth and opening a plastic bottle,objectively.
2. To measure the ADL activity related upper extremity on the same condition using the motion analysis system we built twice for less than one week and examine the reliability of the evaluation index.
Basic objectives2
Others
Basic objectives -Others
Motion analysis
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1.Basic information in patients with stroke ,age and sex
2.The parameters related in stroke
Type,lesion,part,onset after stroke,complication
3.The parameters related in dysfunction,desease severity of motor paralysis, sensory dysfunction and contracture,higher brain disfunction,degree of ADL independence,utility of upper extrimity.
4.Motion analysis evaluation index of ADL movement,Range of motion,time of motion,velocity,Muscle activity,length of motion.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
We measure the ADL activity related upper extremity using the motion analysis system we built to about 10
healthy subjects.
Interventions/Control_2
We measure the second ADL activity related upper extremity using the motion analysis system we built to the same (interventions 1) 10 healthy subjects for less than one week.
Interventions/Control_3
After measuring to the healthy subjects,we measure the ADL activity related upper extremity using the motion analysis system to 10 hemiparetic subjects under the same conditions with the healthy group.
Interventions/Control_4
We measure the second ADL activity related upper extremity using the motion analysis system we built to the same (interventions 3) 10 hemiparetic subjects for less than one week.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Over 20 years old
2.Hemiparesis due to unilateral hemispheric lesion
3.With motor dysfunction of upper extremity
4.150days and over from stroke onset
5.Can keep sitting by oneself
6.Without higher cortical dysfunction
7.Range of motion of the affected upper extremity:shoulder flexion90,elbow extention-40,finger extention0
8.Without severe pain of the affected upper extremity
9.Without severe deep sensory disturbance
Key exclusion criteria
/The enforcement of the clinical evaluation is difficult
/Condition unstable medically
/Contraindications to upper
extremity exercise
1.Severe heart failure
2.Poorly controlled hyper tension
3.Acute systemic disease or fever
4.Acute pulmonary embolism
5.Severe hepatic dysfunction and renal dysfunction
6.Orthopedic diseases which may disturb upper extremity functions
7.With severe cognitive and mental dis orders
8.With metabolic disorders such as acute thyroiditis
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Meigen Liu |
Organization
Keio University School of Medicine
,Japan
Division name
Department of Rehabilitation Medicine
Zip code
Address
35 Shinanomachi,Shinjyuku-ku,Tokyo,
TEL
03-5363-3833
meigenliukeio@mac.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsuko Nishimoto |
Organization
Graduate School of Medicine,Keio University
Division name
Department of Rehabilitation Medicine
Zip code
Address
35 Shinanomachi,Shinjyuku-ku,Tokyo,
TEL
03-5363-3833
Homepage URL
sakurasaku710eena@gmail.com
Sponsor or person
Institute
Keio University School of Medicine,
Japan
Institute
Department
Personal name
Funding Source
Organization
Strategic Research Program for Brain Science
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
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
慶應義塾大学病院（東京都） KEIO UNIVERSITY HOSPITAL.TOKYO,JAPAN
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 10 | 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
Completed
Date of protocol fixation
| 2014 | Year | 05 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 01 | 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
| 2014 | Year | 09 | Month | 30 | Day |
Last modified on
| 2017 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017777
